RU2815756C1 - Method for examination of patients after prostatectomy for presence of incontinence - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to urology, urologic oncology, pelvic surgery, and can find application in objective quantitative assessment of incontinence after prostatectomy. A physiological saline in an amount of up to 200 ml of physiological saline at a comfortable temperature is introduced into the bladder cavity using a catheter under sterile conditions until the urge to urinate. Visual and quantitative assessment of incontinence is performed at each stage with successive changes of body position: standing position at rest; walking; transition from a standing position to a sitting position; transition from a sitting position to a standing position; squatting from a standing position. Every time the body position changes, a cough test is performed.

EFFECT: method provides increasing the objectivity of the incontinence assessment, eliminating the load on the cardiovascular system by introducing the liquid directly into the bladder, besides, it does not require special equipment, at the same time the method is reproducible in real time, easy to interpret the results.

1 cl, 1 ex

Description

Field of technology

The invention relates to medicine, namely to pelvic surgery, urology, oncourology, and can be used when examining patients after prostatectomy for the presence of incontinence.

State of the art

A known pathological condition is urinary incontinence, or incontinence, in which there is an involuntary release of urine that cannot be controlled by the patient, regardless of the volume, causes and degree of discomfort caused. Urination is an important act in the physiology of the human body. Normally, the bladder and urethra function as a single system, carrying out two fundamental processes: the accumulation of urine in the bladder and its emptying. Usually produces 1.0-1.5 liters of urine per day. The average capacity of the bladder is 200-300 ml. Accordingly, the average number of acts of urination per day is 4-6 times. Most often, incontinence does not pose a threat to the patient’s life, but is a very significant social problem for a person. This condition reduces a man’s quality of life, leads to causeless irritability, and has a significant impact on physical, hygienic and psychological well-being. The most important causes of male incontinence are prostate diseases and complications after treatment [Aboyan I.A., Orlov Yu.N., Shevchenko A.N., et al. Urinary incontinence after radical prostatectomy: prognostic factors. Oncourology. 2021;17(1):159-166].

In modern clinical practice, the most popular among physicians is the classification developed by the Standards Committee of the International Continence Society (ICS), which includes the following types of urinary incontinence [D’Ancona C., Haylen B., Oelke M., et al. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019;38:433-477.]:

1. Imperative (urgent). It is characterized by the appearance of an unbearable urge to urinate and associated uncontrollable urine loss. The only cause is an overactive bladder.

2. Stress (urinary incontinence due to stress). Characterized by urine loss associated with increased intra-abdominal pressure. Stress refers to various factors that lead to a sudden increase in intra-abdominal pressure (coughing, laughing, sneezing, lifting heavy objects). Stress incontinence is the most common type of this condition.

3. Mixed - characterized by a combination of symptoms of urgency and stress urinary incontinence.

Determining the type of urinary incontinence is an important diagnostic step. It is recommended to perform a cough test with a full bladder (need to cough or strain) in all patients with urinary incontinence for differential diagnosis between different types of urinary incontinence and planning further treatment [Brukhard F.C., et al. EAU guidelines on Urinary incontinence in adults European Association of Urology. 2017:147-174]. If after coughing and/or straining you urinate or leak urine, the test is considered positive.

The criteria for assessing urinary continence proposed by Russian scientists are worthy of attention [Kogan M.I., Belousov I.I., Mitusov V.V., et al. The influence of techniques for reconstructing the vesicourethral segment during radical prostatectomy on the function of urinary continence: assessment of immediate and long-term results . Journal of Urology. 2022;10(4):54-69.]:

1) complete urinary continence - defined as the absence of urine loss;

2) partial urinary continence - defined as the ability to retain urine in the “lying on the back” position and the ability to voluntarily urinate when changing body position, requiring periodic use of absorbent underwear (social continent);

3) total urinary incontinence - defined as a lack of control over urination, requiring constant use of absorbent underwear.

Currently, it is generally accepted that solving the problems of improving the patient’s quality of life is possible only with mandatory consideration and, if necessary, correction of disorders of the psychophysiological status.

There is a known method for determining quality of life using a questionnaire. A questionnaire is a questionnaire consisting of a different number of questions about subjective feelings of a person’s physical and psychological health. Currently, the WHOQOL-26 (WHOQOL - World Health Organization's Quality of Life), SF-36, EQ-5D, and QOL questionnaires are used in clinical practice. The result of filling out the questionnaire is the data representing the health score of the respondent [Alexandrova E.A., Khabibullina A.R. Methodology for assessing health-related quality of life using the EQ-5D-3L questionnaire. Russian medical journal. 2019;25(4):202-209]. The main advantage of using questionnaires is their versatility, i.e. possibility of use both for extended population surveys and for specific groups of patients and specific patients. The leading disadvantage of all questionnaires is the low information content for assessing incontinence and resolving issues regarding tactics for correcting the pathological condition [Moroz I.N. Tools for assessing health-related quality of life. Military medicine. 2019;4:78-85].

There is a known method of urodynamic diagnosis represented by a urination diary, which allows the patient to record urination processes in a familiar environment. The urination diary is kept by the patient independently in the form of ordinary everyday, dated, synchronous records from the point of view of the system for reflecting reality. When filling out the diary, utmost sincerity and trust are required. The urination diary is filled out within 48-72 hours in order to fundamentally understand that the changes are characteristic not only of today and are associated with a stressful situation, but are actually a trend in the health problems of this patient. During this time, it includes data on the time and volume of urination, the time and volume of fluid drunk, the time of going to bed and waking up, the use of urological pads, the presence of an imperative urge to urinate and episodes of urinary incontinence, which makes it possible to calculate daily and nocturnal diuresis, as well as objectively assess the clinical picture [Prilepskaya E.A., Kolontarev K.B. Methods for diagnosing urinary incontinence in patients who have undergone radical prostatectomy. Honey. Vestn. Bashkortostan. 2011;6(2):274-277]. However, the data from the urination diary must be correlated with the results of other clinical and laboratory studies.

There is a known method for subjectively assessing the severity of urine loss and the degree of incontinence using the ICIQ-SF questionnaire. To determine the impact of incontinence on the quality of life of patients in daily clinical practice, the questionnaire of the International Society of Urinary Incontinence is used [Lucas M.G., Bosch R.J.L., Burkhard F.C., et al. EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol. 2012;62(6):1130-1142]. The ICIQ-SF questionnaire assesses the frequency and severity of urinary incontinence by providing a subjective assessment of objective phenomena. The ICIQ-SF questionnaire consists of 4 questions to which the patient independently answers. After this, the doctor sums up the points and, based on the resulting sum, interprets the results (minor, mild, moderate or severe incontinence). A higher ICIQ-SF score indicates a worse quality of life for the patient. The highest score is ˗ 21. The disadvantage is the subjectivity of data assessment and the lack of quantitative definitions of incontinence.

There is a known method for determining the type of urinary incontinence using the “DRIP-test” questionnaire. The method for determining the type of urinary incontinence is simple and non-invasive. This is a short questionnaire that the patient can fill out independently. The DRIP test questionnaire consists of seven questions (with “yes” or “no” answers), which the patient answers. After filling out the questionnaire, the doctor interprets the results and can classify the data as one of three types of urinary incontinence: overactive bladder or urge incontinence, stress urinary incontinence and mixed type [Porena M., Mearini E., Mearini L., et al. Voiding dysfunction after radical retropubic prostatectomy: more than external urethral sphincter deficiency. Eur. Urol. 2007;52:38-45.]. The “DRIP-test” questionnaire evaluates the patient’s subjective manifestations of the disease and is used as a tool for dynamic monitoring of the effectiveness of treatment. The method lacks the ability to quantify the degree of incontinence.

There is a known method for objective examination of a patient with incontinence, which is a complex urodynamic study (CUDI). It includes several studies that are performed separately or together, depending on the nature of the patient’s symptoms, to assess the function of the urinary tract by measuring various aspects of the filling and evacuation of urine [Kasyan G.R., Khodyreva L.A., Gvozdev M.Yu. , etc. Urodynamic studies in clinical practice. M.: Publishing house "ABV-press". 2016:39p.]. A comprehensive urodynamic study includes:

1. Uroflowmetry (graphic measurement of urine flow rate in ml/sec);

2. Cystometry - a method for assessing the reservoir and evacuation functions of the bladder, based on recording changes in intravesical pressure as the bladder fills or empties;

3. Profilometry is the measurement of intraurethral pressure to assess the closure function of the urethra.

The use of invasive urodynamic testing is indicated in cases where, based on non-invasive testing, it is impossible to accurately diagnose the cause of the urinary disorder. The key point in examining a patient with urinary incontinence is to determine the degree of insufficiency of the urethral sphincter apparatus and the distal urethral sphincter area. The recommended bladder filling volume is 150-250 ml. The assessment of consistency is carried out during the study [Clement K.D., et al. Urodynamic studies for management of urinary incontinence in children and adults // Cochrane database of systematic reviews. 2013;(10):CD003195.]. Correctly performed urodynamic studies can provide additional objective information regarding the functional state of the lower urinary tract.

The closest analogue, adopted as a prototype, is a method for objectively examining a patient, while quantifying the loss of urine when changing the position of the patient’s body in space. Pad test (Pad test) is a quantitative method for assessing incontinence, which consists of recording the number of pads used and weighing the used pads over a period of time. As a rule, a daily pad test is used for analysis, which involves collecting and weighing urological sanitary pads (with a capacity of up to 100 ml) during the day (24 hours). The degree of urinary incontinence is assessed as:

- lightweight when using 1-2 pads,

- medium – with 3-5 pads,

- heavy – with more than 5 pads per day.

The most common occurrence after prostatectomy is stress urinary incontinence, which, depending on the volume of urine lost per day, is divided into 4 stages:

Stage 1 – loss of up to 2 ml of urine per day;

Stage 2 – from 2 to 10 ml per day;

Stage 3 – from 10 to 50 ml per day;

Stage 4 – more than 50 ml per day (volume is assessed using a pad test).

The method is not without drawbacks, such as subjectivity of the data provided by the patient, difficulty in interpreting the data (on the part of the doctor when weighing pads), large measurement errors, especially when weighing pads over a long period of time, for example, per day. In addition, the optimal time interval over which the number of pads used should be assessed has not been established. This test cannot be reproduced in real time (“here and now”) [Trukhan D.I., Yurenev G.L., Makushin D.G., Chusova N.A. Lower urinary tract symptoms: differential diagnosis in primary care. Directory of a polyclinic doctor. 2019;3:23-28].

For more significant urine losses, the severity of urinary incontinence is assessed in clinical practice. There are 3 degrees of severity of urinary incontinence according to D.V. Kanu (1978): light, medium and heavy. In mild cases, involuntary urine leakage is noted only during a sharp and sudden increase in intra-abdominal pressure: severe coughing, fast walking, and the loss of urine is only a few drops. With moderate severity, clinical signs appear during quiet walking, with light physical activity, etc. In severe cases, patients completely or almost completely lose urine even when changing body position [Urology. Russian clinical recommendations / ed. Yu. G. Alyaeva, P. V. Glybochko, D. Yu. Pushkar. - M.: GEOTARMEDIA, 2016:496 p.]. Regardless of the causes of urinary incontinence, an approximate classification of the degree of incontinence has been developed, based on the average amount of urine released uncontrollably within 4 hours:

o - drip – up to 50 ml,

o - light – 50-100 ml,

o - medium – 100-200 ml,

o - heavy – 200-300 ml,

o - very heavy – more than 300 ml.

The degree of urinary incontinence is one of the important factors that should be taken into account when choosing a treatment program and hygienic absorbent products [Gacci M., De Nunzio C., Sakalis V., et al. Latest Evidence on Post-Prostatectomy Urinary Incontinence. J. Clin. Med. 2023;12(3):1190].

The above disadvantages and, above all, the subjectivity associated with the patient’s assessment of the above-mentioned and known methods for assessing the quality of urinary continence, are eliminated in the claimed invention.

Disclosure of the invention.

The objective of the invention is to develop a method for examining patients after prostatectomy for the presence of incontinence using changes in body position in space.

The technical results of the claimed invention are:

- increasing the objectivity of the assessment of incontinence by eliminating the subjectivity of the assessment (interpretation of the condition by the patient himself, violation of the procedure for carrying out diagnostic techniques), which makes it possible to select adequate therapy, thereby improving the quality of life in the early and late postoperative period, as well as reducing the time required for restoration of incontinence;

- eliminating the load on the cardiovascular system by introducing fluid directly into the bladder.

The technical result is achieved through the following techniques.

A saline solution at a comfortable temperature is injected into the bladder cavity until the urge to urinate (mostly the volume of the injected solution is up to 200 ml). In this case, a container for collecting urine is placed at the urethra. After which the patient consistently changes the position of the body in space, while visually and quantitatively determining uncontrolled urine excretion:

- standing at rest;

- when walking;

- when changing the patient’s position from a standing position to a sitting position;

- when changing the patient’s position from a sitting position to a standing position;

- squatting the patient from a standing position;

With each change in body position, an additional cough test is performed.

As a result, the doctor and patient, through visual inspection, assess the quality of urinary continence and quantitative control of involuntary urine loss at rest and during physical activity. At the same time, the load on the cardiovascular system is reduced by introducing fluid for examination directly into the bladder, and the examination time is also reduced by eliminating the waiting period for a full bladder.

The advantage of the method is its reproducibility in real time, ease of interpretation of the results, and the absence of subjectivity on the part of the patient and the doctor assessing and interpreting the results. In addition, the technique described below does not require special measuring instruments.

Implementation of the method.

The preparatory stage consists of catheterization of the bladder in compliance with the principles of preventing contact infection. The manipulation is performed under aseptic conditions in the examination room. Bladder catheterization is performed only with sterile gloves. A sterile catheter is inserted into the patient while lying on a couch, on his back with his legs straightened. Before the procedure, skin areas of the genital organs close to the injection site are treated with a skin antiseptic, i.e. the head of the penis and the external opening of the urethra. Optimal for clinical use in the postoperative period is a sterile two-way Foley catheter with a diameter of 16 Ch with a distal closed end and two side holes and a proximal end with an elastic anti-return valve and a drainage funnel. Application anesthesia of the urethra is performed with the drug Kategel-gel, as well as application of the drug Kategel-gel to the Foley catheter. It is possible to use sterile Vaseline for bladder catheterization. A Foley catheter is inserted through the urethra into the bladder cavity. While passing through areas of urethral narrowing, the man is asked to take a deep breath to relax the muscles. Reaching the bladder is determined by the presence of urine output through the catheter. The volume of the Foley catheter fixation balloon filled through the anti-return valve is 8-12 ml of saline solution.

Up to 200 ml of physiological solution at a comfortable temperature is slowly injected into the bladder cavity through a fixed Foley catheter until the urge to urinate using a Janet syringe. The reduced volume is due to the fact that the patient has undergone prostatectomy and the urethrovesical anastomosis has not yet been fully formed, and the patient may not have an adequate understanding of the mechanism of urinary continence. Tight filling of the bladder (200-250 ml) can cause a backlash with severe urinary incontinence and the result of quantitative assessment of continence will not be objective.

A Billroth clamp or any other clamp is applied to the drainage funnel of the proximal end of the Foley catheter to prevent loss of saline injected into the bladder cavity. A patient with a full bladder moves from a lying position on the couch to a standing position using the strength of the muscles of the whole body. A container for collecting urine for men (“urinal bag”) is brought to the penis. Subsequent changes in body position in space make it possible to visually and quantitatively determine urine loss.

Position 1. Assessment of continence without physical activity in a standing position.

With the patient standing, 8-12 ml of saline is removed from the fixation balloon through the anti-return valve of the proximal end of the Foley catheter. When focusing on maintaining the tone of the muscles of the perineum and pelvic floor (the muscles of the abdominal wall in a relaxed state), the urethral Foley catheter is removed from the urethra. The patient brings a container for collecting urine for men to the penis (“urinal”: a medical basin, or a bucket, or a tray, or just a vessel - preferably with a wide “neck” for clearer visual control - for the purpose of psychological assessment of the patient’s control). A prerequisite is complete relaxation of the muscles of the anterior abdominal wall, i.e. “isolated” keeping only the muscles of the perineum and pelvic floor in tone, since tension in the anterior abdominal wall leads to an increase in intra-abdominal pressure. Accordingly, pressure on the bladder and rectum, which are located in the lower floors of the abdominal cavity, increases, which provokes increased urinary incontinence. The quality of urinary continence and the amount of spontaneously excreted urine at rest while standing are determined. A cough test is performed to detect stress type of urinary incontinence.

Position 2. Assessment of continence during minimal physical activity - walking.

With the patient in a standing position, assessment of continence is carried out by focusing on keeping the muscles of the perineum and pelvic floor (muscles of the abdominal wall in a relaxed state) in tone with minimal physical exertion for the patient, i.e. walking around the office 20-30 steps. During the entire period of loading on the penis, the patient holds a container for collecting urine for men (“urinal”). It is possible to use a urological condom. The quality of urinary retention and the amount of spontaneously excreted urine with minimal physical activity - walking - are determined. A cough test is performed to detect stress type of urinary incontinence.

Position 3. Assessment of continuity when changing body position when moving from a standing position to a sitting position.

The patient is in a standing position with his back to the couch. When focusing on maintaining the tone of the muscles of the perineum and pelvic floor (the muscles of the abdominal wall in a relaxed state), the patient sits down on the couch. During the entire period of loading on the penis, the patient holds a container for collecting urine for men (“urinal”). It is possible to use a urological condom. The quality of urinary retention and the amount of spontaneously excreted urine are determined when the body position changes - the transition from a standing position to a sitting position. A cough test is performed to identify stress urinary incontinence.

Position 4. Assessment of continuity when changing body position - transition from a sitting position to a standing position.

The patient is sitting on the couch. When focusing on keeping the muscles of the perineum and pelvic floor (muscles of the abdominal wall in a relaxed state) in tone, the patient gets up from the couch. During the entire period of loading on the penis, the patient holds a container for collecting urine for men (“urinal”). It is possible to use a urological condom. The quality of urinary retention and the amount of spontaneously excreted urine are determined when the body position changes - when moving from a sitting position to a standing position. A cough test is performed to detect stress type of urinary incontinence.

Position 5. Assessing continuity when changing body position - squatting.

The patient is in a standing position next to and sideways to the couch. When focusing on maintaining the tone of the muscles of the perineum and pelvic floor (the abdominal wall in a relaxed state), the patient squats down. During the entire period of loading on the penis, the patient holds a container for collecting urine for men (“urinal”). It is possible to use a urological condom. The quality of urine retention and the amount of spontaneously excreted urine are determined when the body position changes - when squatting. A cough test is performed to detect stress type of urinary incontinence.

Clinical example.

Patient B., born in 1959. An examination at a medical organization at the site of attachment revealed an elevated PSA of 7.3 ng/ml. A transrectal biopsy of the prostate gland was performed under ultrasound control. Histological conclusion based on the biopsy material: Prostate adenocarcinoma, Gleason index 7 (3+4). During clarifying diagnostics (pelvic MRI, osteoscintigraphy), regional and distant metastatic lesions are excluded.

Planned surgical intervention was performed: Laparoscopic prostatectomy; Extended pelvic-iliac lymph node dissection. Histological conclusion on the surgical material: Acinar adenocarcinoma, Gleason index 7 (3+4), extracapsular extension; No metastases were found in the lymph nodes. The course of the postoperative period is standard. Removal of the urethral catheter on the 10th day. Spontaneous urination has been restored. Discharged from the hospital in satisfactory condition.

At a follow-up visit 3 months after surgical treatment, the patient uses up to 2 diapers per day daily and subjectively feels constant urine leakage. According to diagnostic methods: tumor marker PSA 0 ng/ml; with TRUS, the prostate bed is free, the lymph nodes are not differentiated; rectally, the walls of the rectum are even, smooth, and there are no tumor formations. A general urine test showed no pathology.

The patient was examined using the proposed method. During the examination, 160 ml of physiological solution at a comfortable temperature was slowly injected into the patient's bladder cavity through a fixed Foley catheter until the urge to urinate using a Janet syringe. As a result of visual control, spontaneous urine leakage was not observed during all five positions. When performing a cough test when changing the body position from a sitting position to a standing position (Position 4) and squatting (Position 5), spontaneous release of urine in drops from the external opening of the urethra into a container for collecting urine for men (“urinal bag”) was noted. A quantitative assessment of urine excreted in a urine bag was carried out using a disposable syringe. The excretion of 2 ml of urine was reliably established.

Thus, after a quantitative and visual assessment, a mild degree of urinary incontinence, the stress type, was established. The patient is recommended to use a safety urological pad, Kegel exercises, and neuro-physiotherapeutic rehabilitation techniques. Surgical treatment is not indicated in this situation.

At the follow-up visit 6 months after surgical treatment, the patient uses one safety small urological pad.

Claims (7)

A method of examining patients after prostatectomy for the presence of incontinence, including quantitative determination of involuntary loss of urine when changing body position, characterized in that saline solution is introduced into the bladder cavity before the urge to urinate, a container for collecting urine is placed at the urethra, after which the patient sequentially changes the position of the body in space, while visually and quantitatively determining uncontrolled urine excretion: - standing at rest; - when walking; - when changing the patient’s position from a standing position to a sitting position; - when changing the patient’s position from a sitting position to a standing position; - squatting the patient from a standing position; With each change in body position, an additional cough test is performed.