GB2281512A - Semen-absorbent douche device - Google Patents

Abstract

The device, which is for at least partial insertion into a vaginal or anal cavity, comprises semen-absorbent petaline portions 4 radially disposed relative to an axis of translation of the device, such that (a) in moving upwardly in the cavity, at least one petaline portion may at least partly contact semen, and (b) in moving downwardly, at least one said petaline portion will have at least some semen for withdrawal from the cavity; at least one preselected material 6 comprised by at least one petaline portion for release therefrom in the cavity; and a shaft 2 for introducing the device such that the petaline portions may undergo translational and rotational motions relative to said axis. The material 6 may particularly be a surfactant such as nonoxynol-9 which imparts spermicidal, fungicidal, bactericidal and virucidal properties so that the device may be used to prevent infection and/or to provide contraception. <IMAGE>

Description

INPROVEHENTS RELATING TO VAGINAL AND ANAI. HEALTH At each sexual act without a condom a woman may become the recipient of e.g. Smi of semen. This semen deposition leads to problems, both medical and aesthetic. One problem is related to the change in the pH of the vagina after sex, due to the continuing presence of semen. The vagina is normally highly acid (pH 4), and this acidity protects against penetration and infection by fungi, bacteria and viruses. Semen is alkaline (pH 8), and contains buffering systems which maintain alkalinity for many hours. After sex without a barrier the vagina becomes alkaline and remains so until the following day. Semen acts as a substrate in which organisms can grow. A gradual colonisation of the vagina follows, by commensal organisms which are normally held in check by an acid pH.

Women in monogamous relationships are affected as well as women who change their partners.

Vaginal infections are far more widespread than is generally realised.

Between one third and one half of sexually active women not using barrier contraception experience vaginal infection, often repeatedly, before the age of thirty years. This applies particularly to women using the contraceptive pill (the Pill).

More women aged 20 to 45 years seek medical advice for vaginal thrush infection than for any other reason: Candida albicans, which causes thrush, develops invasive pseudohyphae at pH6. The increasingly recognised anaerobic vaginosis only occurs at a pH more alkaline than 5.5.

Commensal organisms reside (by definition) in the body. They cause problems only if there are changes in the surrounding milieu which favour their growth. Both partners in the sex act have commensal organisms on and in the genital organs. Commensals both from the woman and from the man are a potential source of illness to the woman, particularly if conditions favour colonisation. The problems caused by commensal colonisation tend to be overlooked, because most medical attention is paid to the so-called sexually transmitted diseases, which are caused by highly infectious, pathogenic organisms, not normally resident in the body.

Infections cause inflammation and damage to the protective outer layers of the vaginal and cervical epithelium, impairing resistance to further invasions: genital warts occur almost exclusively in sexually active women with a history of previous vaginal infections. Cervical pre-cancer is closely related to genital wart infection.

Cervical cancer is regarded by many authorities as a sexually transmitted disease.

Chart 1. which is based on research by me in my medical practice, shows the progressive appearance of vaginal infections (95), wart infections (41), pre-cancerous changes or dysplasia (52), then early cervical cancer or carcinoma-in-situ (8), in 253 sexually active women (Pill-starters) aged thirty years or less.

Spermatozoa are known to transport bacteria with them as they penetrate the uterus and Fallopian tubes. The more commensal and anaerobic bacteria in the vagina, the more likely is deeper transport of bacteria by motile spermatozoa.

Salpingitis and pelvic inflammatory disease are common in sexually active women, but less so in those who use barrier methods of contraception. Such infections may result in sterility.

An aesthetic problem is the unpleasant seepage of semen from the vagina over the hours, and even days, after sex. This phenomenon is reflected in the growth of the panty liner market over recent years.

Vaginal douching has been used since antiquity as a form of contraception and as a protection against disease. It worked to some extent: dilute acetic acid, which was a frequent douching liquid, would have immobilised spermatozoa and restored vaginal acidity. Liquid douching was, however, unreliable - and messy.

Contraception before the introduction of the Pill involved the exclusion of semen from the vagina, or its speedy removal. Women who take the Pill have not needed, for the purposes of contraception, to exclude or remove semen from the vagina.

Increase of commensal colonisation of the vagina has been a consequence of the continuing presence of semen.

Many chemical contraceptives, e.g. nonoxynol-9, work by surfactant activity.

They render spermatozoa immobile and act as spermicides by destroying the outer coating of spermatozoa. In order to function as contraceptives such chemicals must be placed in the vagina before sex. However, when they are placed in the vagina after sex they will still immobilise most of the spermatozoa. Furthermore, as well as being spermicides, these surfactants are also fungicides, bactericides and virucides.

It should be noted that, although this application of the invention includes a spermicidal effect, the invention need not be used as a contraceptive.

A first aspect of the present invention provides a device for being at least partly inserted into a vaginal cavity or anal cavity, said device comprising: a plurality of semen-absorbent petaline portions respectively disposed relative to an axis of translation of said device, said petaline portions being disposed relative to corresponding ones of radial axes comprised by said petaline portions, those radial axes being transverse of said axis of translation, such that: (a) in moving upwardly in said cavity, at least one said petaline portion may have at least one open mode whereby surface of that portion may at least partly contact semen, and (b) in moving downwardly in said cavity, at least one said petaline portion may have at least one withdrawal mode whereby that portion will have at least some semen for withdrawal from said cavity; at least one preselected material comprised by at least one said petaline portion for release therefrom in said cavity; and an introductory portion of said device, for introducing into said cavity said petaline portions, such that said introduced petaline portions may undergo translational and rotational motions relative to said axis of translation0 A second aspect of the present invention provides a a method of utilising pH, comprising: (a) providing a vaginal cavity or anal cavity with at least one preselected material that will enable at least part of said cavity to have a suitable pH for said cavity; and (b) withdrawing sperm from said cavity.

The present invention may be embodied and performed in any suitable manner(s). For example, each and every component of a device of the first aspect of the invention may be embodied in any suitable manner(s), and utilised in any suitable manners, for instance as later described below by way of example with reference to the accompanying drawings.

In a device of the first aspect of the invention, preferably at least one said petaline portion has a segmental edge, such that the free end of that portion has at least two segments for successively contacting the wall of said cavity at least once when said introduced petaline portions undergo said rotational motion. At least two said segments of at least one said petaline portion may be adjacent each other and contain therebetween a recess (which may receive sperm).

At least one said segment may have a curved end. Said curved end may be globular. Free ends of said petaline portions may correspond to a suitable figure of rotational contact (e.g. helical contact) of those ends with the wall of said cavity. At least two free ends of said petaline portions may be aligned with respect to each other. At least two free ends of said petaline portions may be angularly separated relative to said axis of translation. Said petaline portion(s) may be constituted in any suitable manners, e.g. two said petaline portions may be constituted by a semenabsorbent member having first and second opposite ends corresponding to angularly separated dispositions (e.g. substantially 1800) relative to said axis of translation, said first and second ends being respective first and second said petaline portions, said plurality of semen-absorbent petaline portions comprising at least one said semen-absorbent member.

At least one said petaline portion may be an absorbent fabric frond, etc. At least two said petaline portions may be identical or different in appearance, and may be symmetrically or etc.disposed.

Said introductory portion of a device of the first aspect of the invention will be embodied suitable for said introduction of said petaline portions. Some examples of said introductory portion are given later below.

Preferably, said at least one preselected material enables at least part of said vaginal cavity or at least part of said anal cavity to have a suitable pH for said cavity. In this respect, the present invention is especially but not exclusively suitable for enabling said vaginal cavity to have a suitable acidic plI for health, preferably a pli in the range substantially 4 to substantially pH 5. Some examples of said at least one preselected material are given later below.

In said method of the first aspect of the invention, said method is preferably carried out by utilising a device of the first aspect of the invention, e.g. to provide a said acidic pH for health. Some examples of said method are given later below.

Some examples of the present invention include: 1. A device suitable as a douche (i.e. a douche device) to be used by a sexual partner after sexual intercourse, in order to combat e.g. vaginal infection due lo commensal colonisation and lo preempt the unpleasant seepage of semen e.g. from the vagina in the hours after sexual intercourse: comprising an elongated introducer with hand grip, a collar of absorbent members (e.g. absorbent fabric fronds) securely attached at the leading end, and areas of pharmaceutically active material(s), e.g.

surfactant gel, positioned for preferably optimum release into the vagina to act as spermicide, fungicide, bactericide, virucide, etc.

2. A douche as in the example above, with a smoothly rounded leading end to the introducer avoiding any trauma to the vaginal epitlielium during insertion, and during rotation.

3. A douche as in any example above, whereby the smoothly rounded leading end is coated by a soft surfactant gel, further protecting the vaginal epithelium on insertion.

4. A douche as in any example above, whereby means are provided to introduce absorbent fabric fronds with a large surface to volume ratio.

5. A douche as in any example above, whereby the absorptive surface and scouring ability of the absorbent fabric fronds is increased by crimping the fabric.

6. A douche as in any example above, whereby the edges of the fabric fronds are coated with surfactant.

7. A douche as in any example above, whereby means are provided to introduce the absorbent fabric fronds into the posterior fornix of the vagina, to rotate them, and to remove them.

8. A douche as in any example above, whereby the soft surfactant gel covering the leading end of the introducer comes to lie in the posterior fornix of the vagina, where it can dissolve in the heat of the body.

9. A douche as in any example above, whereby surfactant from the edges of the fabric fronds is spread throughout the upper vagina and round the cervix when the introducer is rotated.

10. A douche as in any example above, whereby surfactant is applied to the stalk of the introducer between the fabric fronds and the handgrip where it is spread through the mid and lower vagina when the introducer is rotated.

11. A douche as in any example above, whereby the device distributes surfactant widely before the removal of semen and spreads a film of surfactant in the vagina after removal of semen, to destroy potentially harmful fungi, bacteria and viruses lying within the vaginal cavity.

12. A douche as in any example above, whereby the device distributes surfactant widely to immobilise spermatozoa, halting deeper transport of bacteria upon motile spermatozoa into body cavities including the Fallopian tubes.

13. A douche as in any example above, whereby the device leaves behind traces of a suitable perfume.

According to the above examples of the present invention, there may be provided a device to be used by the female partner after sex in order to absorb and remove the semen from the vagina and to introduce protector material(s) e.g.

nonoxynol-9. The device may impart an agreeable perfume after use, etc. The invention achieves the early removal of semen from the vagina, helping thereby to return the vagina to its natural protective acid pH, to prevent vaginal colonisation by commensal organisms, and to minimise the deeper carriage of bacteria upon motile spermatozoa. The invention also preempts the unpleasant drip of semen from the vagina in the hours and days following sex. After insertion into the vagina, the device is retained there while it performs its function of absorption of semen and release of surfactant, and is to be removed within five minutes (as instructed on the packaging), thus avoiding any possibility of toxic shock. The handle of the device, which remains protruding outside the vagina, acts as a further reminder to the user that the device is to be removed after use. The device may be disposable after one single use, thus ensuring that a new and hygienically clean and packaged device is used on each occasion.

Preferably the present invention comprises an appropriate introducer with appropriately shaped layers of absorbent material securely attached at one end, and provided with appropriate quantities of surfactant agent and/or other material(s).

Absorbed material comprised by the douche device may be discarded or utilised if desired for any suitable purpose, e.g. DNA anulysis, etc.

Some embodiments of the invention are shown schematically by way of example in Figures 1 to 9 of the accompanying drawings: Referring to the drawings (Figure 1), a douche device 1 comprises a smooth board, paper or plastic introducer 2 with a head 3 of soft and absorbent fabric fronds or petals 4 attached at the leading end 5 of the introducer 2. A smooth layer of preselected pharmaceutically active surfactant protector gel 6 covers the leading end of the introducer, the edges of the absorbent fabric fronds and the surface of the introducer between the fronds and the handle. The surfactant protector gel contains e.g. perfume, if desired. introducer 2 is a shaft.

In order to allow the absorption of the alkaline semen and help restore the pH balance in the vagina, the inlroducer provides for ihe gentle and deep introduction of absorbent material, such us non-woven fabric, as far as the posterior fornix of the vagina, where most semen lies. In order to allow rupid surfactantinduced immobilisation of spermatozoa, and to facilitate its spermicidal, fungicidal, bactericidal and virucidal action, the introducer provides for the wide distribution of surfactant: by the introduction deep into the posterior fornix of the vagina of surfactant gel covering the leading end of the introducer; by the sweeping action against the cervix and the upper vaginal walls of the fabric fronds which have surfactant-impregnated edges; and by diffusion into the mid and lower vagina of the surfactant present on the shaft of the introducer.

The device may be shaped appropriately so that it can conform to the internal contours of the vagina and to release e.g. surfactant throughout appropriate areas of the vagina, while protecting the vagina from trauma during use.

The lower end of the introducer remains outside the woman's body, and acts as a hand-grip, so that she can rotate tulle introducer gently to fucilitate the absorption of semen by the absorbent fabric fronds, and to facilitate the distribution and deposition of a thin layer of surfactant, and so that she can gently withdraw the device after use. The protruding lower end of the introducer also serves as a further reminder to the user to remove the device after use.

Figure 2 shows the leading end of one introducer shaft 2 with a smooth rounded terminal surface 7, allowing for simple, safe, non-traumatic introduction of the device along the posterior wall of the vagina to rest in the posterior fornix. The smooth rounded leading end is covered by a thin layer of preselected pharmaceutically active surfactant gel 6 which readily liquefies in the body heat of the posterior fornix, disposing of commensal organisms within the semen, and immobilising the spermatozoa.

Figure 2 also shows fabric fronds or petals 4 held securely to the shaft 2 in an appropriate manner. There may be a number of layers of fabric fronds, each slightly separated from the next, thus maximising the absorptive effectiveness of the device. The Figure is in cross-section.

Figure 3 shows a petaline member 4A of absorbent fabric , and may be shaped and/or jolLied in order to increase tlie absorptive surface and the cleansing action when the frond is swept across the vaginal wall. The fabric is highly porous, enabling it to absorb and contain any semen it comes into contact with. The fabric will not disintegrate, nor will it excoriate the vaginal surface.

Figure 4 shows the edge of absorbent fabric, frond or petal 4, where an additional coating of preselected pharmaceutically active surfactant 6 may be held, allowing for the further spread of protective surfactant in the upper vagina and round the cervix when the device is rotated by the user in line with usage instructions.

Figure 5 shows the introducer shaft 2 of one douche device. This shaft may be made of appropriate smooth board or paper tubing of a suitable diameter, or of non-fracturing plastics or wood etc material, of length and flexibility and/or rigidity to allow the absorbent fabric to be introduced to the posterior fornix of the vagina.

The lower part 2A of the shaft 2 is to be held by the user in use, and is ridged to provide a secure grip. The introducer shaft between the fabric fronds and the handle is coated with preselected pharmaceutically active surfactant 6 for release into the vagina to give further protection against infection.

Figure 6 shows schemuticaily one douche device after full insertion into the vagina and after rotation to expose the absorbent surfaces as instructed. The device is now performing its function of absorbing semen and releasing surfactant.

Figure 7 shows schematically a douche device in the process of being withdrawn from the vagina. The action of wiilldrawal pulls the upper, most semenladen fronds downwards, enfolding them within the lower fronds, which are inverted, exposing their under-surfaces to absorb any remaining semen traces, while at the same time releasing and spreading surfactant from their edges and from the surfactant layer on the shaft, as a thin deposit on the walls of the vagina.

Figure 8 shows one douche device with increased application of surfactant or other preselected pharmaceutically active material(s).

Figure 9 is a modification of Figure 1, the modification showing aligned adjacent petals 4 whereas Figure 1 shows angularly separated adjacent petals 4 whose radial axes are substantially 900 apart.

Figure 10 shows chart 1, referred to earlier above.

Figure 11 shows chart 2, referred to later below.

The smooth rounded surface 7 (Figure 2) of the terminal end of introducer shaft 2 may be permanently or removeably fastened to shaft 2, and e.g. constituted by a boss, plug, or the like fastened to the body of shaft 2 by means of at least one fastening means selected from adhesive bonding, interference fit within the body of shaft 2, and screw fastening (for instance by the boss or plug having a screw threaded shank (not shown) that engages with the interior of the body of shaft 2.

it will be appreciated that the provision of the smooth rounder terminal surface 7 may be provided in any suitable manners, e.g. as a moulded or compressed end of shaft 2. Another example is when the body of the shaft 2 has a terminal screw threaded shank (not shown) that engages with the interior of the boss or plug.

Figures 2 and 5 show profiling of the leading end of introducer shaft 2 so as to provide recesses 2B for seating petaline members 4A (Figure 3) comprising petals 4.

The invention provides e.g. five advantages, whereby the vagina is enabled to restore its naturally protective environment and remain free from disease. These five advantages are cumulative: they reinforce one another. Firstly, the invention removes alkalinity from the vagina by removing the semen, so allowing the natural protective acid pH of the vagina to reassert itself quickly; acid-shy commensal organisms are thus kept in check; the production of penetrative pseudo-hyphae of candida albicans is controlled. Secondly, the invention removes the culture medium in which commensal organisms can proliferate unhealihily, by removing the semen substrate. Thirdly, the invention reduces colonisution of the vagina by commensals present in the woman by fungicidal, bactericidal, and virucidal action of surfactant upon organisms within the vagina. Fourthly, the invention reduces colonisation of the vagina by commensals from the man, by removing the semen which contains most of them, and by fungicidal, bactericidal and virucidal action of surfactant on any which may remain. Fifthly, the invention reduces the deeper transport of bacteria carried on motile spermatozoa, by immobilising spermatozoa.

By protecting against commensal colonisation the invention minimises inflammation and damage to the vaginal and cervical epithelium. Intact healthy epithelium affords considerable protection against invasion by pathogenic organisms.

Thus the invention is likely to afford at least some protection against so-called sexually-transmitted diseases, ulhouglr the protection can only be partial, because of the great pathogenicity of these diseases. It is possible that the device affords some protection against the onset of cervical cancer.

Further, the absorption and removal of semen cuts the unaesthetic seepage of semen from the vagina after sex.

It will be appreciated that a douche device of the present invention may therefore have an introducer shaft which is designed for easy insertion into the vagina up to a maximum distance controlled by the user. When the introducer is inserted it conveys absorbent fabric to the posterior fornix of the vagina, where it absorbs the semen which has been deposited there. At the same time the device releases e.g. surfactant into the vagina: the surfactant preferably acts as a spermicide/sperm immobiliser, and as a fungicide, bactericide and virucide. After the semen has been absorbed and the surfactant released, the introducer with the absorbent material now holding the semen is withdrawn from the vagina, and disposed of appropriately.

In the above description, the problem of genito-urinary disorders following semen deposition in the vagina is overcome or reduced by the invention. However, the invention can also be employed for other applications that are not related to this problem.

Thus, the device of the present invention can be embodied and applied for the absorption and release of substances in any orifices and/or ducts and/or cavities and/or delicate areas in the human and/or animal and/or vegetable body and/or inanimate structure. The device can be disposable, it can be re-usable, or it can be partly re-usable (for example, the introducer shaft can be re-usable, with replacement heads of absorbent material for each use occasion). The device can be unitary assembled ready for use in the fuctory, or it can be assembled or disassembled, with or without interchangeable parts, by the user. The device's lieItd can be fixed, as is the absorbent fabric head in the above example, or it can he tree to rotate and/or to traverse on its shaft. The device can be fitted with an aperture at its leading end in order to provide for inspection of the usage site by the user. The device can be fitted with a hole in the leading end and with a plunger inside the introducer tube, in order to allow for liquids to be injected from or aspirated into the introducer tube. The device can incorporate an additional introducer tube, surrounding and housing the absorptive head and shaft, allowing the absorptive head to be advanced from the tube housing, and subsequently withdrawn again into the housing after use. The device can be fitted with a shaft which is flexible or not flexible, straight or angled, jointed or not jointed, and of different sizes and/or rigidity. The absorbent head can be of different size and/or shape and/or material, and can contain different chemicals or combinations of chemicals for release in use, positioned at different points on the invention and in different quantities, or it can contain no additional chemicals. The tip at the leading end and the handgrip at the trailing end of the device can be of diffferent shape and/or size and/or hardness.

Pharmaceutically active material(s) may comprise acid medication to restore vaginal acidity. The absorbent members (e.g. fronds) may be made of paper, or of other cellulose materials, or of woven, sprayed, or compressed absorbent fabrics, or of a mix of materials, etc.

It will be further appreciated by way of example, that the device may additionally be used to release and disperse medication agents before sexual intercourse takes place. This is described below: ALTERNATIVE USE OF lNVPNTION AS PROPIIYI,ACIC INCLUDING AGAINST ATDS Further applications of the invention may be used before or after sexual intercourse. Before sex, the device wiltl increased surfactiint (see Figure 8) is used as a carrier of surfactant or similar lherllpculic substances to tieposit a layer of these substances throughout the vagina. While this entails a certuin loss of spontaneity (as does the use of condoms), the therapeutic coating acts as a specific prophylactic against invasive organisms, including the human immuno-deficiency virus (HIV).

It is known that HIV is a rather fragile organism and that it is killed by surfactants and by other microbicidal substances. After sex, the invention is then used as already detailed above (pages 1 to 9).

A woman having sexual intercourse with a partner who carries the Human Immunodeficiency Virus (HIV) is at risk of contracting IIIV infection, and Acquired Immunodeficiency Syndrome (AIDS). Many studies suggest that her risk of infection is increased if she has inflammation and ulceration of her genital tract: the HIV virus may more easily gain access to her body tissues and blood stream; the virus replicates in the white blaori cells, which are present in inflammation.

The present invention may offer some protection against HIV infection in several ways: (a) When used after sexual intercourse as detailed above i. By absorbing most of the semen, it removes most of the HIV virus.

ii. It adds to the defences of the female partner by spreading a layer of virucide over the vaginal mucosa.

iii. By protecting the user fiom other infections, il makes her less at risk to the inflammation and ulceration which provides sites of entry for the virus in subsequent sexual acts.

(b) When used both before and after sexual intcrcolllse iv. A fourth mode of protection is provided by using the device with increased surfactant (see ligllrc 8) before sexual Iniercourse, in order to coat the vaginal mucosa with a layer of virticide or sinilar lberupeutic substances before any semen is Introduced during sexual intercourse. An additional amount of virucide or similar therapeutic substances is added to the device for introduction into the vagina, thus increasing the protective layer of virucide or similar therapeutic substances prior to sexual contact. After intercourse, the device is used us detailed above (pages 1 to 9).

v. The increased vaginal lubrication provided by use of the inven

Few women taking the Pill use u barrier also. T found that the large majority of my research sample (women up to 35 years) were pill-users, with half of all users starting aged 17 or less. My findings here, are supported by market research (1992), which shows that 77% of women (aged 18-54) never use a barrier (condom).

I found that over half of all women up to 35 years of age suffer vaginal infections and related disorders of Ihe genital tract. In the 2()-35 year old age group, 38% of women suffer vaginal infections, 29% infected cervical smears, and 12% genital warts. These disorders hccollle even more COlmlllOIl In women over 35 years.

The occurrences of these also lords are repeated, with many women suffering four or more episodes, before their 36th birthday.

My research distinguished between known pill-users, (82% of sample), and women who use condoms and/or ubstain from sex (18% of sample). The majority of disorders of the genital tract In women aged 20-35 years, arise in women using a non-barrier contraceptive. This is mostly the Pill. 44% of these women suffered vaginal infections, 35% infected cervical smears, 14% genital warts. Two out of three pill-users had suffered at least one episode of any one of the above disorders, before her 36th birthday. Women who started the pill at a young age (16 years or below) were especially susceptible to these disorders. Women who used condoms and/or abstained from sex, cxperienced a negligible level of these disorders.

Infections also damage the genital tract. Repeat infections are common.

These disorders take time to develop. I found only one fifth of vaginal infections occurred within the first year of starting the pill.

I found that hardly any infections were due to "classical" STD (gonorrhoea, chlamydia, trichomonas). Most are due to commensals, lhut is, micro-organisms normally present in small numbers (such as cundida albicans, Gurdnerella vaginalis, streptococci). Commensal orgunisms are normally held in check by the body itself.

They only cause problems when they proliferate.

The normal vagina is protccted hy a plI of 4. Semen has a pI-I of 7.9 to 8.1, buffered to remain alkaline for up to 18 hours. I found that most sexually active women not using condoms have a normal vaginal pE! nearer 6, and that this pH rises noticeably to 6 and above for a day after sexual intercourse.

During and after sexual intercourse without a barrier, vaginal pH is raised by contact with the alkaline semen. Semen promotes disorders of the genital tract in 7 ways: - it makes the vagina more alkaline and thereby disarms its normal acid pH defences; - it makes the vagina more alkaline and allows commensal organisms of the vagina to proliferate; - it makes the vagina more alkaline and allows commensal organisms from the male to proliferate; - the repeated substrate of atitolysing spermatozoa forms a culture medium in which micro-organisms thrive; - proteases and other enzymes in semen which are necessary for sperm motility irritate the vaginal epithclinnl; - the ulceration and disturbance of the vaginal epithelliim caused by surface infection allows easier ingress of pathogenic micro-orgunisnls; - motile spermatozoa transport orgunisms deeper Inlo the body; Cystitis: Urinary tract infections are common in women, especially sexually active women. Cystitis, and "urethral syndrome", are often triggered by coitus. I found 16% of women aged 15-30 had bacteriologically proven cystitis. 68% of these women with cystitis also had vaginal infection, suggesting a continuum of infection. A number of patients had the same unusual organism isolated from both bladder and vagina, months apart. The commonest organism isolated in cystitis is Escherichia coli; peri-urethral colonisation by E.coli has been recognised in women with vaginal infections; spermatozoa curry E.coli on their motile tails; spermatozoal carriage of infectious organisms has been recognised in salpingitis; non-motile organisms have been isolated from the bladder of women subject to repeated cystitis for several days after coitus. I collclude that cystitis is oflen related to spermatozoal carriage of potential pathogens.

Pre-cancer: The health of pill-users is monitored closely. 95% of my pill-user sample had cervical smears. I found that over one in five pill-users aged 35 and under had abnormal smear results (dyskaryosis, cervical dysplasia). By contrast, only one in 40 women using barrier contraceptives und/or abstaining from sex showed smear abnormalities. 68% of the abnormal smears had been heralded by prior vaginal infections. One third of ubnornnal smears became more serious over time.

Abnormal smears, i.e. pre-cul)w r ous changes, are limited to sexually active women.

Semen contains large amounts ol prostatic amines, which icily be metabolised by anaerobic bacteria to produce carclll(lgellic substances: calcinogenic nitrosamines are produced by anaerobic bacteria in other sites of the body, e.g. stomach in pernicious anaemia. I conclude that the removal of seminal amines is likely to reduce the incidence of cervical abnormalities. Moreover, the DNA of spermatozoa has been implicated by some workers in cervical neoplastic change.

Taking in aggregate the disorders - vaginal infections, infected smears, genital warts, and abnormal smears, I found that around two out of three pill-users under 36 years had suffered at least one episode of any one disorder, compared with one in ten women never using the pill and/or abstaining from sex.

Although condoms are protective, women using the Pill rarely choose to use them in addition. In contrast to condoms and to other barrier contraceptives, the invention is used after sex, and does does not detract from the spontaneity of sex.

It is used by the woman, for her own benefit, independently of the male partner.

The invention allows the woman to remove most of the semen from her vagina following sex, and disperse a protective medication (for example, nonoxynol9, or a combination of surfuclulll and acid gel) in her vagina. By removing the semen, she removes the agent which dlsturbs her vaginal pH balance, irritates her vaginal epithelium, transports organisms into her body, and fllrnishes a substrate in which pathogens can grow. ny dispersing protective medication, she helps restore a normal vaginal pH, and she destroys remaining organisms from the man. By maintaining her vaginal pH ut ils design level, she hells protect herself against infections. By protecting herself against vaginal infections Including genital warts, and the deleterious components of semen, it is likely she will also give herself some protection against cervical cancer.

It will be appreciated that1 by way of further example of this invention, the device's head may also be fitted e.g. with a drawstring for the purposes of withdrawal. The douche device may be fitted with an introducer tube and no shaft, the head being introduced by means of the introducer tube and subsequently withdrawn by means of a drawstring.

In this specification, the words absorb, absorbent, absorption also refer to adsorb, adsorbent, adsorption. The word cavity refers e.g. to hole, hollow space, canal, duct, etc. The words fabric, tissue, woven, non-woven may refer to absorbent or adsorbent natural- and/or man-made material. The words frond, petal, piece may refer to any rounded, polygonal, or rounded and polygoaul plate or plane of absorbent or adsorbent material, etc, offering u prefcruily convenient surface-tovolume ratio. The words fold, folded refer to any suitable folding for increasing surface area, e.g. crimped, corrugated, dimpled, furrowed, pllckered, ridged. The words douche, douching describe cleansing for medical nr rteslllelic purposes of body surfaces or body cavities, with or without use of lie"id, or a douche device used for such cleansing. The words applicator, stalk, introducer, handle, shaft refer to the introductory portion of the device. The expression pharmaceutically actiye material describes substance or substances having a preselected therapeutic and/or medical biochemical effect or effects (e.g. suitable surfacla ) at the site of delivery, etc. The word disposable means thut all or part(s) of the device may be disposed of after a single use or after an intended number of uses, or that different parts of the device are to be disposed of after u different number of uses, etc.

It will be appreciated that some aspects of the present invention can be summarised by the following items: 1. A douche device for belug at least partly inserted into a cavity in which is absorbable material, said device comprising: at least one absorbent portion of the device, for being introduced into the cavity, at least one introduced said absorbent portion being able to absorb at least a portion of said absorbable material, wherein at least one said absorbent portion is optionally a semen-absorbent portion for being introduced into a cavity of a person or animal; un introductory portion of the device, for introducing said at least one absorbent portion into Ille cavity, the introductory portion being connected to saitl el Icusl oi)e absorbent portion; and optionally at least one preselected material conll)lisell by the device, sllcll that at least some of that material may become available in tlie cavity.

2. A device as described in item 1, wherein at least one said absorbent portion is a semen-absorbent portion for being introduced into a vaginal or anal cavity of a person or animal.

3. A device as described in item 1 or 2, wherein at least one said absorbent portion is adjustably positionable relative to said introductory portion.

4. A device as described in item 1 or 2, wherein at least one said absorbent portion is fixedly positioned relative to said introductory portion.

5. A device as described in any one of items 1 to 4, wherein at least one said absorbent portion comprises a plurality of edges.

6. A device as described in item 5, wherein said plurality of edges is at least partly circumferentially arranged relative to said introductory portion of the device.

7. A device as described in any one of items 1 to 6, wherein at least one said absorbent portion comprises at least one absorbent frond.

8. A device as described in any one of items 1 to 7, wherein there is a single said absorbent portion or a stacked plurality of said absoll)ent portions.

9. A device as described in any one of items 1 to 8, wherein at least one said absorbent portion comprises absorbent fabric und/or ui)sorl)(:llt tissue, at least part of which may be woven or non-woven.

10. A device as described In any one of items 1 to 9, wherein at least one said absorbent portion is an absoi'lent crimped portion.

11. A device as described In any one of items 1 to 10, wherein at least one said absorbent portion is adnptcd to comprise at least some of said at least one preselected material.

12. A device as described in item 11, wherein at least one edge of at least one said absorbent portion is adapted to comprise at least some of at least one said preselected material.

13. A device as described in any one of items 1 to 12, wherein said introductory portion comprises a first end portion thereof connected to said at least one absorbent portion, motion of said first end portion thereby being able to move said introduced at least one said absorbent portion.

14. A device as described in item 13, wherein said introductory portion comprises a second end portion Ihercofa said second end portion being adapted to be a hand grip.

15. A device as described In item 14, wherein said second end portion is profiled, said profiling optionally comprising at least one ridge.

16. A device as described In any one of items 1 to 15, wherein said introductory portion is adapted In sllllpe for being inLrr,tlllccd Into a vaginal or anal cavity of a person or animal.

17. A device as described ln any one of Ilciiiu l lo 16, wherein said introductory portion comprises at least some of said at least one preselected material.

18. A device as described in item 17, wherein intermediate between said first and second end portions of said introductory portion, at least part of the intermediate region of said introductory portion is adapted to comprise at least some of said at least one preselected material.

19. A device as described in any one of items 1 to 18, further comprising a sleeve surrounding said introductory portion so that said introductory portion may be advanced or retracted relative to said sleeve, to allow ut least one said absorbent portion to advance or retract relative to said sleeve.

20. A device as described in any one of items 1 lo 19, comprising at least one terminal portion of the device, said at least one terminal portion being forward of said at least one absorbent portion, said at least one terminal portion being adapted in shape to avoid or reduce risk of trauma when in a vaginal cavity of a person or animal.

21. A device as described in item 20, wherein said terminal portion is adapted to comprise at least some of said at least one preselected material.

22. A device as described In any one of items 1 to 21, when comprising at least one said preselected material, that material optionally being pharmaceutically active.

23. A device as described iii licin 22, wherein nl least some of said at least one preselected material is chosen llonl gels, water s()lIIl)le threads, aerosol foams, waxes, creams, lubricants, pastels, powders, granules, water-based liquids, oil-based liquids, pessaries, surfactants, and unguents., and water soluble films.

24. A device as described in item 22 to 23, wherein at least one said preselected material has sperniici(le activity.

25. A device as described In any one of items 22 to 24, wherein at least one said preselected material has fungicide activity.

26. A device as described in any one of items 22 to 25, wherein at least one said preselected material has bactericide activity.

27. A device as described in any one of items 22 to 26, wherein at least one said preselected material has virucide activity.

28. A device as described in any one of items 22 to 27, wherein said at least one preselected material has pli activity to enable the cavity to have a desired pH, optionally in the range substantially pH 4 to substantially p11 5.

29. A device as described in any one of items 22 to 28, wherein at least one said preselected material comprises nonoxynol-9.

30. A device as described In any one of items 22 to 29, wherein at least one said preselected material comprises octoxynol.

31. A device as described in any one of items 22 to 3 ), wherein at least one said preselected material comprises D-isobutylphenoxypolyethoxyethanol.

32. A device as described in any one of items 22 to 31, wherein said at least one preselected material comprises deodorant material and/or perfume material.

33. A device as described in any one of items 1 to 32, wherein at least a portion of the device comprises llt least one uperture uscable for inspection of the usage site.

34. A device as described in any one of items I to 33, wherein at least a portion of the device comprises an aperture for containing plunger means for allowing at least one preselected material to be injected into or aspirated from the cavity.

35. A device as described in any one of items 1 to 34, when adapted such that at least a portion thereof may be disposed of after ut least one use of the device.

36. A kit of parts for providing at least a portion of a device as described in any one of items 1 to 35.

37. A method for treating a cavity, comprising utilising a device as described in any one of items 1 to 36.

38. A method as described In Item 37, wherein the device enables the cavity to have a desired pH, optionully in the range substantially pal 14 to substantially pH5.

Having regard to the above description of the present invention, my UK research provides the evidence repofled below: ORAL CONTRACEPTION ANI) SUBSEQUENT TERMINATION OF PREGNANCY, VAGINAL INFECTION ANI) CERVI('AI. DYSPLASIA: TWO AUDITS IN GENERAL PRACTICE Obiectives - To study the pattern of oral contraception use, termination of pregnancy, vaginal infection and cervical precancer in young women.

Design - Two audits two years apart.

Setting - One general practice.

Subjects - 582 female patients: 15-33 years on 31.12.1991 (Audit 1); 15-35 years Main outcome measures - Age at start and length of use of oral contraception, pregnancies, genital infections, cervical smear results, colposcopy reports.

Interventions - After Audit 1 no prescription of oral contraception to patients aged 16 years or younger; patients taking oral contraception advised also to use condoms; patients with cervical dysplasia advised to change from oral to barrier contraception.

Results - In two audits 59 of 82 patients (72%) with terminations of pregnancy previously took oral contraception, us did 162 of 178 (91 /,) with vaginal infections, and 90 of 92 (98%) with abnormal smears. 22% of patients started oral contraception aged 16 years or younger, but subsequently had 34% of terminations of pregnancy, 38% of vaginal infections and 3X% of al)llol ll smears. Timing and bacteriology of infections suggeslcd slow vaginal colonistitlon. Infection preceded abnormal smears in 61 patients (66%). Of 48 patients with cervical dysplasia, all 14 (29%) with increasing abnormality, including infiltrating udenocarcinoma, continued oral contraception.

In 1990-91 teenage patients had 3 terminations of pregnancy and 12 vaginal infections, and 14 patients developed cytological abnormalilies: followed in 1992-93, teenage patients had no terminations of pregnancy and 5 vaginal infections, and 6 patients developed cytological abnormalities.

Conclusions - Patients using oral contraception without a barrier suffer double jeopardy from infection and hormone-induced cervical changes. Patients starting oral contraception young have most subsequent termination of pregnancy, vaginal infection, and cervical precancer. Patients developing cervical dysplasia should change from oral to barrier contraception.

In July 1991 Oxfordshire lowered the age of entry to cervical screening from 25 years to 20 years. I decided to preview the notes of my women patients aged 2024 before issuing screening Invitations. I was satisfied lo find that over 80% of those who had a record of marriage, pregnancy or contriiception had already had cervical smears. However, I was dlslllslyod by tlie numbers who Ilrtd terminations of pregnancy (TOP), vaginal infections, all cervical dysplasla, almost all users of the oral contraceptive pill (OCI'). I he a more extensive study.

AUDIT 1. 31.12.1991 I reviewed the medical notes of all 412 female patients aged 15 to 33 years registered with the practice on 31.12.1991, tabulating date of birth, contraceptive history, pregnancies, vaginal infections confirmed by higll vaginal swab reports (HVS), genital warts, genital herpes, l3artholin's adenitis, hospital admission for pelvic inflammatory disease, cervical smears and colposcopic reports.

I found the date of starting OCP in contemporary entries (242 patients), or filed Family Planning Clinic (FPC) form-letters (41 patients) in the medical notes: I asked 10 patients who took OC1' with no recorded starting date, when they started OCP.

Oral contraception: 293 patients had taken OCP, using 26 different brands. 215 patients currently took OCP on 31.12.1991. 98 patients started OCP aged 16 years or younger ('young-starters' ) (CHART 2). 105 patients started OCP before 31.12.1981.

Termination of pregnancy: 57 patients had TOP, 36 after being established on OCP, including 16 'young-starters' (CHART 2). 27 patients had TOP during their teens. In 1990-91 7 patients had TOP, including 3 ill their teens, 10, 23 anal 33 months after starting OCP.

Vaginal infections: 122 patients, includlug 37 in tlielr teens, had 210 episodes of vaginal infection with 240 pathogens (TABLE 1): 114 of these liad 190 episodes after starting OCP (TABLE 1), including 48 'young-starters' (Cl tART 2). 11 patients had vaginal infection (10% of initial episodes) within 6 months, 25 (22%) within one year, and 58 (51%) within 3 years, of starting OCP: of 27 patients who used condoms before OCP 7 had vaginal infections, one before starting, and 6 within one year of starting, OCP. Vaginal infectious occurred in 61 never-pregnant patients and 20 patients before their first pregnancy. In 1990-91 49 patients, including 12 in their teens, had 30 initial and 26 recurrent episodes of vaginal infection.

Other related infections: 94 patients had infection and inflammation reported in cervical smears: candidal hyphae (18), trichomonads (8), 'bacterial exudaie' (6), and 'inflammatory exudate' (76): 91 took OCP, including 42 'young-starters'. In 32 patients smears were so inflamed that cytologists requested repeat smears, commenting: "Cell detail obscured by inflammatory exudate", "Regret mainly white blood cells", or "Unsatisfactory. Almost entirely pus".

Related infections were recorded: genital warts (47 patients, 34 with clinical warts, 27 with wart virus cliaiiges in cervical smears); salpingitis and pelvic inflammatory disease (9 hospital admissions); genital herpes (7); l3artholin's adenitis (5); chlamydia in currettings after a third miscarriage (1). All patients had taken OCP for six months or more, except for one patient with genital warts who used a diaphragm.

Abnormal cervical smears: 60 patients had cytological nl)normalily reported In cervical smears (TABLE 2), 8 while in their teens. In 1')9 91 14 patients developed abnormal smears, including one 19-year-old and 6 aged 20-24 years. 5 patients had smears showing increasing abnormality (TABLE 2).

16 patients had colposcopy: 13, with biopsies confirming cervical intraepithelial neoplasia (CIN), had diathermy or laser ablation: one aged 22 years had hospital admission for secondary haemorrhage, and one year later had repeat ablation for recurrent CIN3. In 5 patients biopsies showed more abnormality than preceding smears (TABLE 2).

42 patients with cytological abnormality had previous infection in HVS and/or smears: 34 patients had genital warts.

59 patients with cytological abnormality started OCP 74:E42 months previously: in 55 OCP was the only recorded contraceptive method (45 currently took OCP, 10 had abnormal post-natal smears after tukillg OC5P for 3 years or more before pregnancy); 4 took OCi' for 5-11 years, then cllullgcd to diaphragm, intrauterine device (IUD) or tubal ligalion 1-3 years before diagnosis. 6 patients with increasing or recurrent abnormality continued taking OCP. One patient took no OCP, but used a diaphragm for 3 years before developing mild dysplasia.

25 of 98 'young-starters' (25%) developed cytological abnormalities (CHART 2), compared to 34 of 195 patients (17%) who started OCP aged 17 years or older, and 8 of 57 patients (14%) who started OCP aged 20 years or older. More than one third of 'young-starters' who started OCP 10 years before audit had developed cytological abnormality (Table 3).

EVALUATION OF AUDIT 1 Patients had suffered more morbidity than expected. Requests for TOP continued, despite easy access lo conlrilccplioll. Indecel, 'young-starters' had the highest incidence of TOP, vaginal infection and cervical pre-cancer. Of 60 patients with cytological abnormality, only 1 had never taken OCP and 4 had changed from OCP to another method of contraception. All with worsening smears had continued with OCP.

After Audit 1 I changed my advice to patients. I decided not to prescribe OCP, for contraception or dysmenorrhoea, to patients this age.

Patients registered before 31.12.1991: Oral contraception: 22 patients started OCP in 1992-1993: 2 patients aged 16 years were prescribed OCP, one in the practice and one at an PI'C: 2 more 16-year-olds, unidentified, attended an FPC . 23() patients had allell(ly started OCP before 31.12.1991, including 76 'yottlig -starters Termination of pregnancy: In 1992-3 no TOP, or births, occurred in patients in their teens (175 patientyears). 5 older patients had TOP, all after taking OCP, including 2 'young-starters'.

Vaginal infection and related infections: In 1992-93 (TABLE 1) 23 patients, including 5 in their teens, had initial vaginal infections, and 4 repeated infections: 19 took OCP, including 8 'youngstarters'. 17 patients with initial infections before 31/12/91 had 19 further episodes of infection: 16 took OCP, including 9 'young-starters'.

9 patients had infection reported in cervical smears, 3 with smears unreadable because of infection: 4 patients had genital wart changes in smears: 2 had genital herpes: all were taking OCP. None had Bartolin's adenitis. None were admitted to hospital because of salpingitis or pelvic inflammatory disease.

Abnormal cervical smears: In 1992-93 6 patients with previously normal smears developed cervical abnormality (TABLE 2), and 4 patients with abnormal smears before 31.12.1991 had increasing cervical abnormality rA131,8 2). 6 of these, aged 28-35 years, had colposcopy. All had biopsies confimling CIN, and were treated with cervical ablation: 3 had more abnormality In biopsies than smears Cl'AflLE 2). 5 with new, and 3 with increasing, abnormalities had previous vaginal infection. 5 with new, and 4 with increasing, abnormalities liad genital wart infections.

All 10 patients currently took OCP, started 1()7i62 months before diagnosis.

2 patients with new abnormalities and 3 with Increasing ubllarlnlllities were 'young starters'.

Patients registered after 31.12,1991.

Oral contraception: 115 patients took OCP, including 26 'younger-stlirters'.

Termination of preananov: 20 patients had TOP: 18 were previously established on OCP, including 10 'young-starters'.

Vaginal infections and related infections: 33 patients had 50 episodes of vaginal infection (TABLE 1): 29 took OCP, including 11 'young-starters'. Patients taking OCP also had infected smears (29), genital warts (16), genital herpes (3), pelvic inflammatory disease (2 hospital admissions), and Bartholin's adenitis (1). 2 patients who never took OCP had Bartholin's adenitis.

Abnormal cervical smears: 26 patients had abnormal smears (TABLE 2). 5 patients had increasing abnormality in subsequent smears (TABLE 2). 9 patients had colposcopy. 7 had biopsies confirming CIN, and wure ireated with cervical ablation. 4 had more abnormality in biopsies than smears ('I'Al31,1; 2). 14 lla(l previous vaginal/cervical infections. 14 had genital wart virus infection.

25 patients took OCP, starting 78l58 months before diagnosis, including 8 'young-starters'. All 5 with increasing abnormality continued taking OCP: one patient developed infiltrating cervical udeno-curcinomll aged 29 years following mild, then severe dysplasiu; cone biopsy showed incomplete excision of adenocarcinoma; repeat cone biopsy and hysterectomy followed; she started OCP aged 17 years, and continued OCP until hysterectomy 18 years later. One patient never took OCP, developing mild dysplasia 3 years ofter successful treatment for Hodgkin's Disease.

Cervical screening and follow-up: In 2 audits 416 patients had 1453 cervical smears, screening 412 of 467 patients (88%) aged 20-35 years, and 327 of 343 patIents (95%) aged 25-35 years, including 28 of 63 women (44% aged 20-35 years who never took OCP.

Initial smears were nominal in 65 of the 92 patients with cervical abnormality: 13 had border-line dyskaryosis and 14 had cervical dysl)lllsia in first smears, as young as 18 years. Abnormal smears were reported in 34 never-pregnant patients, in 19 patients before their first pregnancy, and in 39 previously pregnant patients, including 14 with previous TOP.

Patients with cervical abnormality had close follow-tip: 78 patients later had normal smears, 25 after cervical ablation; one had hysterectomy. However, 4 patients left the practice in 1992-3 with border-line dyskaryosis in the most recent smear, and 9 remaining patients had persisting, recurrent, or recently reported abnormality at 31.12.1993.

DTSCUSSTON: The paperwork of pro-activity is orderly, with agreed protocols for Pill Checks, mail-merged invitations lo attend for cervical smears, and fully-booked appointment lists for Well Woman Clinics, The documentation preserved in patients' medical records tells a mown: disordered slory, with hospital summaries after termination of pregnancy or llll)arolollly, reports of i)llctclilll lests and abnormal smears, and notifications of colposcol)y and cervical ablation.

Among 582 patients, tlle oldest 35 years old, 82 had terminations of pregnancy, 195 had vaginal infections, 132 had infection in cervical smears, 67 had genital warts and 92 had cervical smears showing cytological abnormalities: 44 with borderline dyskaryosis, 47 with cervical dysplasia/CiN, one with infiltrating cervical adenocarcinoma. Patients attended conscientiously for screening: 95% of patients aged 25-35 years had cervical smears. Nevertheless, the incidence of cervical neoplasia was similar to that found by Pereyra in women convicts in 1961(1).

Little morbidity occurred before patients started OCP; 72% of patients having TOP were previously established on OCP, as were 91% of patients with vaginal infections, 98% with genital wart Infections, 97% wiih infected smears, and 98% with cervical cytological abnormalities. Moreover, patients who started OCP younger had more problems, and had them earlier: 'young-starters' were 22% of patients/29% of OCP-takers, with 31% of TOP, 38% of vaginal infections and 38% of cervical cytological abnormalliles.

Since legislation in 1967 made OCI' officially available to unmarried women (2) prescriptions have been wrlttei' for ever younger i)LLtlCIItS (3). The promised fall in teenage pregnancies has not occurred (4): failure of treatment may follow even one forgotten Pill (5). Ready prescription of oral contraception officially sanctions early sexual activity in young people who might otherwise delay (6).

Against the current trend, after Audit 1, I decided not to prescribe OCP to patients aged 16 years or younger. Patients could have attended an FPC: only 3 did so. During the next 2 years there were no terminations of pregnancy in patients in their teens. It is too early to judge the effect of my advice that young patients postpone the start of OCP, thut OCP-users use condoms us well, and that patients with cervical precancer discontinue OCP, but in 1992-93 there were small falls in incidence of infections and abnormal smears.

Vaginal infections wcrc: Iitintingly frelL1ent, particularly as I counted only clinical episodes with namely organisms in IIVS. Moreover, u third of patients attending for screening had infection in cervical smear, one in ten with smears so purulent that cytological examination was impossible. 9()% of infections, including all salpingitis and pelvic inflammatory discase, occurred in patients who had taken OCP for 6 months or more, weakening influential claims that oral contraceptives "reduce the risk of pelvic inflammatory disease by about .5()%" (7).

Candida albicans was the collunollest identification. Candidaiasis has been a problem for women taking OCP from the start (8): "one of the most noticeable trends" documented in Morbidity Statistics in General Practice 1981-82 was the rise in incidence of genito-urinary candidaiasis from "relative nlrity" in 1971-72 to "the most common cause of cons lllallol for women aged l5-44 years" (9). Gardnerella and anaerobes were also common, often in mixed infections: they thrive in company with other pathogens (10,11). 14 had beta-haemolytic streptococci: 9 had trichomonas in HVS or smears: 7 had chiamydia, probably under-diagnosed in standard HVS: one had gonorrhocu.

A minority of patients contracted undoubted sexually transmitted infections.

However, many developed vaginal infections within an npparently monogamous relationship; most of the identified orgunisms were recognised vaginal (12,13) or rectal commensals (13,14); and 73% of initial vaginal infections were reported in patients who had taken OCP for more than a year. I propose that most vaginal infections are the result of slowly developing bacterial colonisation, made possible by changes in vaginal milieu in sexually active patients who do not use a barrier method of contraception.

At puberty the vagina hecomes ucid, with p114 (its) lurgely through the activity of acidophilic lactobaclill (16): semen Is alkaline with plI 7.9-8.1, buffered to remain alkaline for up to 16 hours after ejaculation (15). Repeated sexual intercourse without a barrier, by nilsing vaginal pull, fervours the growth of opportunistic micro-organisms no lollger Inhibited by acidity: candida albicans replicates on the surface at acid pull, but at p1 16 prodllces germ tubes capable of penetrating deeply into epithelium (17): bacteria crowd the surface of epithelial clue cells in anaerobic vaginosis at pH5-6 (18). Semen contains many active enzymes, including prostatic proteases, necessary for spenn motility (19), but affecting the pathogenicity of bacteria (20), and capable of acting dircclly upon vaginal tissues.

Autolysing spermatozoa provide substrate for saprophytic anaerobes. Moreover, in hormonally-induced cervical ectropion, particularly common in young patients taking OCP (21,22), protective squamous epithelium at the cervical os is replaced by delicate endo-cervical mucosu, vulnenible to trauma and ingress of micro-organisms, (21,22). including genital warts (23), aetiologically important in cervical cancer (23), Of 92 patients with cervical abnormalities 61 (66,) liad previously recorded vaginal and/or cervical infections: 53 (58%) 'lad genital wart Infection, including 38 of 48 (79%) with cervical dysplasla. Muliiple infectious lay have a synergistic effect (24): carcinogens have been isolated from candida alblcans (25); anaerobes release a variety of damaging virulence factors (26). In another p1 I-sensitive milieu the high incidence of gastric cancer ili penilclous anteiiila has been linked to carcinogenic nitrosamines produced by achlorhydria-associated alluerobe overgrowth (27), and it may be relevant that many rectul commensals reduce nitrate to nitrite (28), that semen is rich in prostatic ermines (19), and that umines have been identified in bacterial vaginosis (29) with malodorous discharge (30).

Although condom use protects women from infection (31), few patients in this study used condoms. Television advertisements for con(loms, concentrating on infection during casual sexual encounters, fail to promote condom use for established couples. 27 patients stopped using condoms on starting OCP: within a year 6 had vaginal infections.

Condom use has been reported to allow regression nf ClN (32), possibly by protecting the cervix from repeated exposure to 'promoting filctors' in semen (32) or to spermatozoal DNA (33), by decreasing cervical infection (34), or by cessation of use of OCP. Women using Iii l)s have no frirrier lo scrnen: they have more infections (35), but fewer cervical abnormalities than ()('l-users (36). Adverse effects of oestrogens on cervical epitliclium were described before (37), and after (36,38-41), the introduction of oral contraceptives. Few patients recruited in 1968-74 for longterm studies started oral contraception as early as their teens (36, 41).

Studies have disputed adverse effects of oral contraceptives, but they described patients who used OCP briefly (42,43), were older than controls (44,45), or averaged 4 pregnancies before diagnosis of cervical cancer (43). Other studies found an association between OCP and cervical cancer and pre-cancer, but then dismissed the association as due to bias from enhanced diagnosis in OCP-users (46), or due to confounding variables of sexual activity (47), and smoking (48). However, confounding variables were excluded by Vessey et al, who followed 10,000 patients using OCP or IUD for 10 years, found invasive cervical cancer confined to OCPusers, and carcinoma-in-situ and cervical dysplasia commoner in OCP-users, and recommended cervical smears after 4 years on the Pill to "enable serious disease to be detected and treated while it is curable" (36).

Cervical screening was expected to eliminate invasive cancer (49). Instead, the death rate in women under 35 years has been rising since 1970 (50), with previously rare variants increasingly reported, particularly in younger women (51).

Doctors have been castigated for failures in the screening programme (52), but in the present study the problem was not inadequate screening, but the frequency of abnormalities, and their unpredictability. 14 patients (29% of those with cervical dysplasia) had increasingly abnormal smears, emphasisillu the potential danger of even 'borderline' and 'mild' dys)laslll (53): continued oral contraception may have accelerated the deterioration (54). Murcovcr, in 12 patients cervical biopsies showed greater abnormality than preccdillg smears: biopsies ciii through the deeper layers containing the most disordered cells (55), whereas smears sample the surface, the site of maximal maturity, so hilt occasionul tinder-calling ol' cytological abnormality is probably inevitable.

Most smears are normal and in any year only a few unfortunate patients learn that they have developed cervical pre-cancer. However, cumulatively a substantial number of patients are affected: in these audits 20% of patients aged 20-35 years developed cytological abnormalities. Since 1970 the number of abnormal smears has escalated (56), identifying potentially deadly lesions (57), early perhaps, but post facto, necessitating costly, unpleasant treatment (58), and frequent follow-up. Draper and Cook postulated that screening was holding in check a much larger potential increase in invasive cancer (SO). Cervical cancer has been predominantly a disease of older women who had married young and borne children (59): in this study, 90 of 92 patients with cytological abnormalities liad undergone prolonged 'pseudopregnancy' due to OCP (8), while only 39 patients had a previous pregnancy. Young age at first coitus is associated with increased Incidence or cervical cancer (60): in this study, 35 of 126 yotlng-starlers (28%) developed cervical abnormalties, compared to 55 of 304 patients (IfZ ) who lulled ()(I' nued 17 years or more.

Before the introduction of OCP, carcinoma-in-situ was uncommon in women younger than 30 years (61), yet 16 of my patients developed the equivalent CIN3 before their thirtieth birthday. Just as screening was gaining momentum (62), oral contraception became available to 'the generations born since 1940 (who) have been experiencing ever-increasing mortality rules' from cervical cancer (63). It appears possible that the beneficial effect of screening has mitigated, and even obscured, harmful effects of oral contraception on the cervix. Individual practices cannot offer decisive data, because of patient mohility and because patients' preference for OCP leaves few controls who never use OCP (64), but u cytology laboratory or colposcopy clinic would have no difficulty In enlisting groups of practices with sufficient patients for a prospective epidemiological study.

*REFERENCES 1. Pereyra AJ The relationship of sexual activity to cervical cancer: Cancer of the cervix in a prison population Obstet Gynecol 1961;17:154-l59 2. Cartwright A Parents and family planning services London: Routledge and Kegan Paul, 1970 3. Vessey MP Oral contraception and cancer In: Filshie M and Guillebaud J, eds.

Contraception: Science and practice London: Butterworth-Heinemann, 1989: 52-68 4. Pearson JF Preventing unwanted pregnancies BMJ 1991;303:598 5. Metson D Lessons from an audit of unplanned )regiiiiiicies BMJ 1988;297:904-906 6. Boyer CB Psychosocial, behavioral, and educational factors in prevenling sexually transmitted diseases.

Adolescent Medicine:State of tlie Art Reviews 1990;1:597-613 7. Drife J Complications of combined oral contraception In: Filshie M and Guillebaud J, eds.

Contraception: Science and practice London: Butterworth-Heinemunn, 1989:39-51 8. Yaffee HS, Grots I Moniliasis due to norethynodrel with mestranol N Engi J Med 1965;272:647 9. Morbidity Statistics from General Practice 1981-1982 Series MBS no.1 HMSO 10. O'Dowd TC, West RR, Ribeiro CD, Small JE, Munro JA Contribution of Gardnerella vaginalis to vaginitis in a general practice BMJ 1986;292:1640-1642 11. Willis AT, Phillips KD Anaerobic Infections: clinical unsl laboratory practice Luton: Public Health Laboratory Service, 1988 12. Bump RC, Sachs LA, Buesching WJ Sexually transmissible infectious agents in sexually active and virginal asymptomatic adolescent girls Pediatrics 1986;77:488-494 13. Corbishley CM Microbial flora of the vagina atitl cervix J Clin Pathol 1977;30:745-748 14. HolstE Resevoir of four organisms associated with bacterial vaginosis suggests lack of sexual transmission J Clin Microbiol 1990; 28:2035-2039 15. Masters WH and Johnson VE Human Sexual Response Boston: Little,Brown and Company, 1966 16. Redondo-Lopez V, Cook RL, Sobel JD Emerging role of lactobacilli ill the control and maintenance of the vaginal bacterial microflora Rev Inf Dis 1990;12:856-872 17. Mendling W Vulvo-vaginal eandidosis: theory und l)nlclice.

Berlin: Springer-Verlag, l9X 18. Schneli JD Cytology and microbiology of tile vagina Basel: Karger, 1973 19. Jecquier AM, Crich JP Semen analysis: A practical guide Oxford: Blackwells, 1986 20. McGregor JA, Lawellin D, Franco-Buff A, Todd JK, Makowski EL Protease production by microorgunisms associated with reproductive tract infection Am J Obstet Gynecol 1986;154:109-114 21. Harrison HR, Costin M, Meder Jn, Bownds LM, Sim DA, Lewis M et al Cervical chlamydia trachomatis infection in university women: relationship to history, contniception, ectopy, and cervicitis Am J Obstet Gynecol 1985;153:244-251 22. Moscicki A-B, Winkler B, lrwiii CE, Schlachter J Differences in biologic maturation, sexual behavior, aiid sexually transmitted disease between adolescents with iind without cervical intraepithelial neoplasia J Pediatr 1989;115;487-4'93 23. Bosch FX, Munoz N Human papillomavirus and cervical neoplasia: a critical review of the epidemiological evidence In: Munoz N, Bosch FX and Jensen OM, eds.

Human papillomavirus and Cervical Cancer Lyon:IARC Scientific Publications No.94, 1989:134-151 24. Zur Hausen H Human genital cancer: synergism between two virus Infections or synergism between a virus infection and initiating events? Lancet 1982;ii:1370-1372 25. Blank F, Chin O, Just G, Meranze DR, Shimkin Ml3, Wieder R Carcinogens from fungi pathogenic for man Cancer Res 1968;28:2276-22t l 26. Finegold SM, George Wl" Mulligan ME Anaerobic Infections Chicago: Year Book Medical Publishers, 1986 27. Ruddell WSJ, Bone ES, ilill MJ, Walkers CL Pathogenesis of gastric cancer In pernicious anaeiiila Lancet 1978;i:521-523 28. Wilkinson JF Tests employed in bacterial identification In: Cruickshank R, ed.

Medical Microbiology: u guide to the laboratory diagnosis and control of infection Edinburgh: E and S Livingstone, 1965:810-841 29. Chen KCS, Forsyth PS, Buchunan TM, Holmes KK Amine content of vaginal fluid from ullllcllled sntl treated patients with nonspecific vaginItis J Clin Invest 1979;63: 828-835 30. Brand JM, Galask RP Trimethylamine: the substance mainly responsible for the fishy odor often associated with bacterial vaginosis Obstet Gynecol 1986;68:682-685 31. Stone KM, Grimes DA, Mugder LS Personal protection against sexually transmitted diseases Am J Obstet Gynecol 1986; 155:180- 188 32. Richardson AC, Lyon JlS The effect of condom use on squamous ccll cervical intraepithelial neoplasia Am J Obstet Gynecol 1981;140:909-913 33. Gagnon F Contribution to the study of the etiology and prevention of cancer of the cervix of the uterus Am J Obstet Gynecol 19S();6():516-522 34. Coppleson M and Reid B The etiology of squamous carcinoma of the cervix Obstet Gynecol 1968;32:432-436 35. Kelaghan J, Rubin GL, Ory HW, Layde PM Barrier-method contraceptives and pelvic inflammatory disease JAMA 1982;248:184-187 36. Vessey MP, Lawless M, McPherson K, Yeates D Neoplasia of the cervix uteri and contraception: a possible adverse effect of the Pill Lancet 1983;ii:930-934 37. Zuckerman S Effects of prolonged oestrin-stimulation on the cervix uteri Lancet 1937;i:435-437 38. Kaminetzky HA, Swerdlow M Sex steroids and experimental invasive atypia in mice Am J Obstet Gynecol 1964;89:716-722 39. Melamed MR, Koss LG, Flchinger BJ, Kelisky RP, Dubrow H Prevalence rates of uterine cervical carcinoma in situ for women using the diaphragm or contraceptive oral steroids BMJ 1969;3:195-200 40. Bornstein J, Adam E, Adler-Stortliz K, Kaufman Il I Development of cervical und vaginal squamous cell neoplasia as a late consequence of In utero exposure to dietliylsillbestrol Obstet Gynecol Surv 1988;43:15-21 41. Beral V, Hannaford P, Kay C Oral contraceptive use itiid nlt nllncles of the genital tract Lancet 1988;ii:1331-1335 42. Thomas DB Relationship of oral contraceptives to cervical carcinogenesis Obstet Gynecol 1972;40:508-518 43. Boyce JG, Lu T, Nelson JELL, Fruchter RG Oral c J Obstet Gynaec Br Cwlth 1972;79:673-679.

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Oral contraceptives and cervical cancer risk in Costa Rica.

Detection bias or causal association? JAMA 1988;259:59-64 47. Swan SH, Brown WL Oral contraceptive use, sexual activity, unul cervical cancer Am J Obstet Gynecol 1981;139:52-57 48. Clarke EA, Hatcher J, McKeown-Eyssen GE, Lickrish GM Cervical dysplasia: association with sexual behaviour, smoking and oral contraceptive use? Am J Obstet Gynecol 1985;151:612-616 49. Macgregor JE Cervical carcinoma: The beginning of the end ? Lancet 1967;ii:1296-1299 50. Cook GA, Draper GJ Trends in cervical cancer and carcinoma in situ in Great Britain Br J Cancer 1984;50:367-375 51. Elliott PM, Tattersall MAIN, Coppleson M, Russell P, Wong F, Coates AS, et al Changing character of cervical cancer in young women BMJ 1989;298:288-290 52. Editorial. Cancer of the cervix: death by Incompetence Lancet 1985;ii:363-364 53. Campion MJ, Singer A, Mitchell HS Complacency in diagnosis of cervical cancer BMJ 1987;294:1337-1339 54. Stern E, Forsythe AB, Youkeles L Coffelt CF Steroid contraceptive use and cervical dysplasia: increased risk of progression Science 1977;19:1460-1462 55. Buckley CH, Butler EB, Fox 11 Cervical intraepithelial neoplasia J Clin Pathol 1982;35:1-13 56. Wolfendale MR, King S, l1sherwood MMcD Abnormal cervical smears: are we In for an epidemic ? BMJ 1983;287:526-528 57. Kinlen LJ, Spriggs Al Women with poitive cervical smears but without stirgical intervention.

A follow-up study Lancet 1978;ii:463-465 58. Campion MJ, Brown JR, McCance DJ, Atia W, Edwards R, Cusick J et al Psychosexual trauma of un abnormal cervical smear Br J Obstet Gynaecol 1988;95:175-181 59. Stocks P Cancer of the uterine cervix and social conditions Br J Cancer 1955;9:487-494 60. Rotkin LD Relation of adolescent coitus lo cervical cancer risk JAMA 1962;1 79:486-491 61. Pedersen O Spontaneous course of cervical precancerous conditions Am J Obstet Gynecol 1936;72:1()63-1071 62. Way S, Duran F, Peberdy M, Stefan MA Vaginal cytology in "well women" Lancet 1963;ii:624-626 63. Beral V, Booth M Predictions of cervical cancer incidence and mortality In England and Wales Lancet 1986;i:495 64. Kay CR New oral contraception sourly: Ixilot trial report Royal College of Generul ikactitioners' Manchester ltescilrch Unit J Roy Coll GP 1986;36:545-546 Chart 2: Audit 1 - Age when patients started oral conlruception, and age of OCP-start in patients having subsequent terminations of pregnancy1 vaginal Infection, infection in smears, genital warts, and cervIcal cytological abnormalities.

Table 1: Audits 1 and 2 - Micro-organisms named in reports of high vaginal swabs. Most infections occurred in patients taking oral contraception.

Table 2: Audits 1 and 2 - Cervical abnormalities in smears and biopsies, showing increasing morbidity over time.

Table 3: Audit 1: - 10 years after starting OCP, patients starting aged 16 years or younger had almost twice the incidence of ubllormlll smears comlitired with patients starting aged 17 years or older.

TABLE 1: MICRO-ORGANISMS NAMED IN HVS REPORTS NUMBER OF IDENTIFICATIONS Never took OCP Took OCP Total (119 patlonl8) (293 patIents) (412) MICRO-ORGANISM Before Allor IDENTIFIED start start OCP OCP AUDIT 1: 31/12/1991 Candida albicans 5 2 115 122 Gardnerella vag. 3 1 63 67 Anaerobes 0 2 7 9 B-haemolytic strep. 0 1 12 13 Other streptococci 1 3 7 11 Trichomonas vaginalis 0 0 8 8 Chlamydia trach. 0 0 4 4 Staphylococcus aureus 0 0 3 3 Coliforms 1 1 0 2 Neisseria gonorrhoea 0 0 1 1 TOTAL 10 10 220 240 AUDIT 2: 31/12/1993 a) Patients registered before 31/12/1991 Candida albicans 5 2 24 31 Gardnerella vag. 0 0 8 8 Anaerobes 0 0 1 1 B-haemolytic strep 0 0 1 1 Other streptococci 0 0 2 2 Chlamydia trach. 0 0 2 2 Staphylococcus aureus 0 0 1 1 TOTAL 5 2 39 46 b) Patients registered after 31/12/1991 Candida albicans 2 2 24 28 Gardnerella vag. o 0 7 7 Anaerobes 0 2 4 6 Streptococci 0 0 3 3 Trichomonas vag. 0 1 0 1 Chlamydia trach. 0 0 1 1 Staphylococcus aureus 0 0 1 1 Coliforms 0 0 1 1 TOTAL 2 5 43 50 TABLE 2: Cervical abnormalities In smears and biopsles Borderllne Corvlcal dysplasla CA dvskarvasla CIN1 CIN2 ClN3 cervix Audit 1: 31/12/91 Inltial abnormalities 34 18 4 4 0 Increasing abnormality In subsequent smears (5) Worse biopsies than smears (5) Worst result; 31/12/91 Left practice 1992/3 Audit 2: 31/12/93 a) Patients from Audit 1 Worst abnormallty:31/12/91 New abnormalities Increasing abnormality in subsequent smears (4) Worse biopsies than smears (3) b) Patients new In Audit 2 Initial abnormalities Increasing abnormality in subsequent smears (5) Worse biopsies than smears (4)

Worst result: 31/12/93 41 18 8 12 Total both audits 44 21 9 17 XEY: O - initial state; - latest atatol (16) = time in months TABLE 3 AUDIT 1: CERVICAL CYTOLOGICAL ABNORMALITY 10 YEARS AFTER STARTING OCP Started Pill Started Pill Total 16 years or 17 years or younger older ~~~~~~ Patients 46 59 105 Borderline 8 7 15 dyskaryosis Cervical 9 5 14 dysplasia Total abnormal 17 12 29 (37%) (20%) (28%) The present disclostires of the Invention also include the appended claims, drawings, and abstract of the invention. The disclosures of the claims, drawings, and abstract are herci,y imported into the above description.

Claims (17)

1. A device for being at least partly inserted into a vaginal cavity or anal cavity, said device comprising: a plurality of semen-absorbent petaline portions respectively disposed relative to an axis of translation of said device, said petaline portions being disposed relative to corresponding ones of radial axes comprised by said petaline portions, those radial axes being transverse of said axis of translation, such that: (a) in moving upwardly in said cavity, at least one said petaline portion may have at least one open mode whereby surface of that portion may at least partly contact semen, and (b) in moving downwardly in said cavity, at least one said petaline portion may have at least one withdrawal mode whereby that portion will have at least some semen for withdrawal from said cavity; at least one preselected material comprised by at least one said petaline portion for release therefrom in said cavity; and an introductory portion of said device, for introducing into said cavity said petaline portions, such that said introduced petaline portions may undergo translational and rotational motions relative to said axis of translation.

2. A device as claimed in claim 1, wherein at least one said petaline portion has a segmental edge, such that the free end of that portion has at least two segments for successively contacting the wall of said cavity at least once when said introduced petaline portions undergo said rotational motion.

3. A device as claimed in claim 2, wherein at least two said segments of at least one said petaline portion are adjacent each other and contain therebetween a recess.

4. A device as claimed in claim 2 or 3, wherein at least one said segment has a curved end.

5. A device as claimed in claim 4, wherein said curved end is lobular.

6. A device as claimed in any one of claims 1 to 5, wherein free ends of said petaline portions correspond to a suitable figure of rotational contact of those ends with the wall of said cavity.

7. A device as claimed in any one of claims 1 to 6, wherein at least two free ends of said petaline portions are aligned with respect to each other.

8. A device as claimed in any one of claims 1 to 7 wherein at least two free ends of said petaline portions are angularly separated relative to said axis of translation.

9. A device as claimed in any one of claims 1 to 8, wherein two said petaline portions are constituted by a semen-absorbent member having first and second opposite ends corresponding to angularly separated dispositions relative to said axis of translation, said first and second ends being respective first and second said petaline portions, said plurality of semenabsorbent petaline portions comprising at least one said semen-absorbent member.

10. A device as claimed in any one of claims 1 to 9, wherein at least one said petaline portion is an absorbent fabric frond.

11. A device as claimed in any one of claims 1 to 10, wherein said at 7east one preselected material enables at least part of said cavity to have a suitable pH for said cavity.

12. A device as claimed in claim 11, wherein said suitable pH is in the range substantially pH 4 to substantially pH 5.

13. A device as claimed in claim 1, substantially as hereinbefore described with reference to and as shown in the accompanying drawings.

14. A method of utilising pH, comprising: (a) providing a vaginal cavity or anal cavity with at least one preselected material that will enable at least part of said cavity to have a suitable pH for said cavity; and (b) withdrawing sperm from said cavity.

15. A method as claimed in claim 14, wherein said suitable pH is in the range substantially pH 4 to substantially pH 5.

16. A method as claimed in claim 14 or 15, comprising utilising a device as claimed in any one of claims 1 to 13.

17. A method as claimed in claim 14, substantially as hereinbefore described with reference to and as shown in the accompanying drawings.