JP6296432B2 - Method for determining dysuria - Google Patents

Description

  The present invention relates to a method for determining dysuria.

(Urination disorder)
The World Health Organization (WHO) lists dysuria as well as Alzheimer's disease and osteoporosis as three major diseases to be overcome in the 21st century.
Among these, “dysuria” is a general term for abnormalities related to urination. And this dysuria includes many symptoms. Symptoms that can be included in dysuria include urinary urgency, frequent urination, urinary incontinence (immediate, abdominal pressure, mixedness, etc.), pain and discomfort in the bladder, pelvis (lower abdomen, sputum, urethra, Pain / discomfort in the perineum, testicles, scrotum, etc.), urine, decreased urinary retention / disappearance, delayed urination, decreased urinary dysfunction, urinary lineage disruption, abdominal pressure urination, terminal dropping, residual urine sensation, and pathological conditions Examples include detrusor overactivity (urodynamic examination findings characterized by involuntary detrusor contraction during the bladder infusion phase, which occurs spontaneously or by evoked stimuli), low-compliance bladder, bladder perception Enhancement {(during intravesical pressure test by infusion method) initial bladder fullness occurs early (early urinary intention) or strong urinary urgency occurs early in low bladder capacity}, bladder perception decreased , bladder perceived lack, non-specific bladder perception, bladder pain, urinary urgency Furthermore, as the cause of dysuria, overactive bladder, neurogenic bladder, interstitial cystitis, and the like.

(Diagnosis method for dysuria)
As a method for diagnosing the various urination disorders, a method of diagnosing based on a urination function test result has been generally employed. Specifically, in this method, first, water is poured into the bladder via a catheter, or spontaneous urine storage is performed by self-produced urine.
Next, the urination phenomenon from the urine storage period to the discharge period is reproduced by discharging the liquid accumulated in the bladder. At this time, the urination function is evaluated by monitoring in detail the activity of the bladder and / or urethra, and further, diagnosis and pathological analysis of the urination disorder are performed based on the evaluation result. Specific examples of such a micturition function test include urine flow measurement, residual urine measurement, bladder pressure measurement, urethral pressure measurement, internal pressure urine flow test, external sphincter electromyogram, urinary bladder / urethrography, and the like.

  Diagnosis / pathological analysis of dysuria based on the results of the micturition function test is usually defined only by the bladder capacity in the urine storage phase, and is widely performed because abnormalities in the urination function can be observed more directly. is there. However, this method can only evaluate the functions of the lower urinary tract such as the bladder and urethra, and the nervous system (especially the central nervous system) that regulates the function by controlling the lower urinary tract is considered to be a lesion. There is a problem that only a part (particularly, peripheral nervous system) can be estimated.

(Example of urination function test)
The present inventors have reported the following as an example of a urination function test.
Patent Document 2012-45168 (Patent Document 1) states that “a method of using a near-infrared analyzer for measuring a hemoglobin concentration parameter in blood on the surface of a subject's brain, wherein the measured hemoglobin concentration parameter is: Used to determine whether the subject is a patient with dysuria or a high-risk person, and for the waveform of the hemoglobin concentration parameter during the urine accumulation period, 1) subtract the average basic value at the start from the average value at the end The slope of dividing the value by bladder capacity decreases or becomes negative compared to normal, and 2) increases and then decreases, when the subject is a patient with dysuria or high risk thereof The method of using a near-infrared analyzer characterized in that it is determined that the person is a person ".
However, in the above method, the use of a near-infrared analyzer is indispensable.

Neurourology and Urodynamics 26: 904-907 (2007) (Non-Patent Document 1) states that “Patients with dysuria are more urgent with respect to bladder capacity than normal subjects without dysuria. Is disclosed.
However, the above method does not disclose or suggest the relationship between the visual analog scale { Visual Analog Scale (VAS) } and the bladder capacity, and cannot identify each urination disorder.

(Parkinson's disease)
Lower urinary tract disorders are observed in Parkinson's disease (PD). Major symptoms include frequent urination, urgency, and urinary incontinence. As the background, detrusor overactivity (DO (Detrusor Overactivity) is a concept proposed by the International Continent Society of 2002. The presence of urinary urgency with frequent urination is the main feature and may be accompanied by urge urinary incontinence}. However, the details of urinary dysfunction during PD and its background in PD patients are not clear.

As described above, many diagnosing and pathological analysis methods have been proposed for dysuria, but there are problems with each of the conventional methods, and there are sufficient methods that can be used clinically. The current situation is not established.
Furthermore, there is currently no useful parameter for quantitative evaluation regarding abnormal urinary urgency, such as urgency that occurs at the time of DO.

Neurourology and Urodynamics 26: 904-907 (2007)

JP2012-45168

  In view of the prior art as described above, an object of the present invention is to provide a method for determining dysuria.

The present inventors have conducted intensive research with the aim of solving the above-described problems. As a result, the following surprising findings were obtained, and the present invention was completed based on the findings.
(1) By urinating bladder perception using bladder capacity measurement and VAS, it is possible to quantitatively measure the trend of urinary intention during the urine storage period.
(2) The value obtained by subtracting the VAS value at the start of the urine storage phase from the VAS value at the end of the urine storage phase is divided by the value obtained by subtracting the bladder capacity at the end of the urine storage phase from the bladder capacity at the start of the urine storage phase. The slope value indicates a value specific to each dysuria.

That is, the present invention is as follows.
1. A method for determining dysuria,
1) the value obtained by subtracting the VAS value at the start of accumulating urine phase from urine collection period at the end of the visual analog scale {Visual Analog Scale (VAS)} value of the subject, the bladder capacity at the end of the accumulating urine Period Comparing the slope value divided by the value subtracted from the bladder capacity at the start of the urine accumulation period with the slope value of a normal person without dysuria;
2) When the inclination value of the subject is higher or lower than the inclination value of the normal person, it is determined that the subject is a patient with dysuria or a high-risk person thereof. ,
How to determine dysuria.
2. 2. The method of determining dysuria according to item 1 above, wherein the determination of high is made when the inclination value of the subject is 1.3 times or more than the inclination value of the normal person.
3. The urination disorder is urgency, frequent urination, urinary incontinence, bladder pain / discomfort, pelvic pain / discomfort, urination, decreased urination, disappearance, urination delay, urinary decline, urinary discontinuity, abdomen Pressure urination, terminal dropping, feeling of residual urine, detrusor overactivity, low-compliance bladder, increased bladder perception , bladder perception, lack of bladder perception , nonspecific bladder perception, bladder pain, urgency, overactive bladder, neurogenic 3. The determination method according to item 1 or 2, which is 1 or 2 or more selected from the group consisting of bladder and interstitial cystitis.
4). In the method for determining enhancement of bladder perception, when the value of the inclination of the subject is in the range of 0.040 to 0.072, the method includes a step of confirming that the subject has enhancement of bladder perception by a known bladder perception enhancement determination method 4. The determination method according to item 3 above.
5. In the method for determining detrusor overactivity, when the inclination value of the subject is in the range of 0.031 to 0.091, it is confirmed that the subject has detrusor overactivity by a known detrusor overactivity determination method. 4. The determination method according to item 3, including a step.
6). In the method for determining decrease in bladder perception, when the inclination value of the subject is lower than the inclination of the normal person, a step of confirming that the subject has decreased bladder perception by a known bladder perception decrease determination method 4. The determination method according to item 3 above.
7). 4. The determination method according to item 3, including a step of determining that the subject has a lack of bladder perception when the inclination value of the subject is substantially zero in the determination method of lack of bladder perception.
8). 8. The determination method according to any one of items 1 to 7, wherein the subject is a Parkinson's disease patient.

  According to the present invention, each urination disorder can be determined by a simple technique.

Laboratory findings during the urine storage period Relationship between bladder perception enhancement and bladder capacity of typical case of DO and VAS Relationship between bladder capacity and VAS in normal cases Relationship between bladder capacity and VAS in bladder perception enhancement cases Relationship between bladder capacity and VAS in DO cases

(Outline of the present invention)
The present invention relates to a method for determining dysuria. The determination method of the present invention is to subtract the value obtained by subtracting the VAS value at the start of the urine storage phase from the VAS value at the end of the urine storage phase from the bladder capacity at the start of the urine storage phase from the bladder capacity at the end of the urine storage phase. The value of the slope divided by the measured value is compared with the reference value of each dysuria to identify the type of dysuria of the subject ”.

(VAS used in the present invention)
The VAS used in the present invention is the urine accumulation phase of the urodynamic test {when urine accumulation is generated by forced water injection, from the start of forced water injection until the subject's bladder capacity reaches the maximum bladder capacity (at this point, During the period of forced irrigation), first bladder sensation {First sensation: FS, (when injecting bladder pressure test is the first time the patient feels full)}, first urination { First desire to void: FDV (during intravesical pressure testing by infusion method) The patient wants to urinate if there is a next opportunity, but feels that he can postpone if necessary}, normal desire to void: NDV , Urinary intention to go to the toilet in everyday life), strong urinary urgency {strong desire to void: SDV, (during urinary bladder pressure testing) Usually maximum urine (maximum In addition to observation (measurement) of the bladder capacity at the time of their appearance, desire to void: MDV), the urinary intention in each situation is evaluated step by step with the maximum urinary intention in daily life as 10.

(Decision to be used in the present invention)
The determination used in the present invention is based on the amount of change in urinary intensity (VAS) / the amount of change in bladder capacity (especially slope and curve). The measurement period of the amount of change is usually between first urine (FDA) and usually maximum urinary (MDV). However, the measurement time of the amount of change in a case in which DO appears is preferably between the time of appearance of DO and usually maximum urinary volatility (MDV). This is because the gradient as the amount of change suddenly increases due to the appearance of DO.

(Criteria used in the present invention)
The criteria used in the present invention are based on the results of laboratory findings in the urine collection phase (see: FIG. 1) obtained in the following examples, and the relationship between bladder capacity and VAS in normal cases without dysuria (see : Fig. 3), the relationship between bladder capacity and VAS in the case of enhanced bladder perception (Reference: Fig. 4), and the relationship between bladder capacity and VAS in the DO case (Reference: Fig. 5), and further graph the amount of change in VAS / bladder It calculated based on the amount of change (slope) of the capacity (see: Table 1 below).

As is clear from the results of the slope of each case in the above table, the increase in bladder perception and the change in strength of DO urine / change in the bladder capacity (slope) are those who do not have dysuria (normal subjects) Compared with the amount of change in strength of urine / the amount of change (slope) in bladder capacity. In particular, the inclination value of the subject is 1.3 times higher than the inclination value of the normal person.
The amount of change in urinary intensity / bladder volume change (slope) of decreased bladder perception is considered to be smaller than the change in urinary strength / bladder volume change (slope) of normal subjects. .
The amount of change in urinary intensity due to lack of bladder perception / the amount of change (slope) in bladder capacity is considered to be almost zero.

(Urination disorders that can be determined by the determination method of the present invention)
The dysuria that can be determined by the determination method of the present invention is not limited to the above-described bladder perception enhancement, DO, bladder perception reduction, and lack of bladder perception, and can be similarly applied to the determination of other dysuria. . For example, urinary urgency, frequent urination, urinary incontinence (immediateness, stress, mixed), bladder pain / discomfort, pelvis (lower abdomen, vagina, urethra, perineum, testicles, scrotum, etc.) Pain, discomfort, urination, decreased urination, disappearance, urination delay, urinary decline, urinary tract disruption, abdominal pressure urination, terminal dropping, residual urine sensation, and dysuria, low-compliance bladder, nonspecific Causes of bladder perception, bladder pain, urgency, and dysuria include neurogenic bladder and interstitial cystitis.

(Determination method of urination disorder of the present invention)
The method for determining dysuria according to the present invention is as follows.
1. Determination method of bladder perception enhancement When the value of the slope, which is the amount of change in the VAS of the subject / the change in the bladder capacity, is in the range of 0.040 to 0.072 (0.056 ± 0.016), the bladder perception enhancement or its risk is high. Therefore, after confirming whether or not the subject has enhanced bladder perception by a known bladder perception enhancement determination method, the enhancement of bladder perception is determined.
2. Method for determining detrusor overactivity When the slope value, which is the amount of change in the VAS of the subject / the amount of change in the bladder capacity, is in the range of 0.031 to 0.091 (0.061 ± 0.030), DO or its risk is high. Therefore, after confirming whether the subject has detrusor overactivity by a known detrusor overactivity determination method, the detrusor overactivity is determined.
3. Determination method of decrease in bladder perception When the slope value, which is the amount of change in the VAS of the subject / the amount of change in the bladder capacity, is lower than the slope of the normal person, the bladder perception is reduced or the risk thereof is high. Therefore, after confirming whether or not the subject has a decrease in bladder perception by a known bladder perception decrease determination method, a decrease in bladder perception is determined.
4). Determination method of lack of bladder perception When the value of the slope, which is the amount of change in the VAS of the subject / the amount of change in the bladder capacity, is almost zero, it is determined that the lack of bladder perception or its risk is high.

  EXAMPLES Hereinafter, although an Example demonstrates this invention more concretely, the technical scope of this invention is not limited to these.

(Measurement of bladder capacity and measurement of bladder perception using VAS)
In the urine accumulation phase of the subject's urodynamics test, initial bladder fullness (FS), initial urinary intention (FDV), normal urinary intention (NDV), strong urinary intention (SDV), normal maximal urinary intention (MDV), and their appearance In addition to the measurement of bladder capacity, the urinary intention in each situation was evaluated step by step with the maximum urinary intention in daily life as 10. Details are as follows.

(subject)
57 subjects with Alzheimer's disease who received informed consent {27 men, 30 women, average age 61.3 years (52-75 years)}. Of 57 patients, 11 cases were normal, 25 cases were enhanced bladder perception, and 21 cases were DO cases.

(Urine flow test)
1) Asked the subject to sit on the examination table and urinate if possible {Urine flow measurement (free flow) of urination function test}.
2) The examination table was tilted and the subject was placed in the supine position, and then a urinary catheter and a rectal catheter were inserted. Then, a needle electrode was inserted into the external anal sphincter.
3) The amount of urine remaining in the bladder was measured (residual urine measurement).
4) The subject was returned to the sitting position, and the intravesical pressure, rectal pressure, and detrusor pressure were confirmed as necessary.
5) Injection of water into the bladder (start of the urine storage period) and recording of events (for example, DO occurrence) were performed while recording the intravesical pressure curve (recording of the urine storage period of the urination function test).
6) Water injection was stopped when the subject's maximum bladder capacity was reached (end of urine storage phase).
7) The subject was instructed to urinate and the subject was urinated {Urine flow measurement (pressure flow) of the urination function test}.
8) The amount of urine remaining in the bladder was measured (residual urine measurement).

(Results of laboratory findings during the urine storage period)
The measurement results of bladder capacity and the measurement results of bladder perception using VAS are shown in FIG. Further, FIG. 2 shows the relationship between bladder perception enhancement and bladder capacity of representative examples of DO and VAS.
In addition, the relationship between the bladder capacity and the VAS in the normal case without dysuria, the relationship between the bladder capacity and the VAS in the case of enhanced bladder perception, and the relationship between the VAS of the bladder capacity in the DO case are shown in FIGS. It was shown to.
As is clear from FIG. 3, in the normal case, a slow increase in bladder perception was confirmed as the bladder capacity increased.
As is clear from FIG. 4, in the bladder perception enhancement example, a sudden increase in bladder perception was confirmed from the beginning with respect to an increase in bladder capacity.
As is clear from FIG. 5, in the DO example, a sudden increase in bladder perception was confirmed after the appearance of DO.
From the above, it was confirmed that the graph of the relationship between bladder capacity and VAS had a shape specific to each dysuria.

  The urination disorder determination method of the present invention can determine each urination disorder by a simple technique.

Claims (1)

A method for assisting determination of bladder perception enhancement and / or detrusor overactivity, which is a dysuria ,
1) The value obtained by subtracting the VAS value at the start of the urine storage phase from the Visual Analog Scale (VAS) value at the end of the urine storage phase from the bladder capacity at the end of the urine storage phase. Obtaining a value of the slope divided by the value subtracted from the bladder capacity at the start of the urine storage phase;
2) Since it is determined that the inclination value of the subject is obtained from a patient with increased bladder perception or a high-risk person thereof, the inclination value of the subject is compared with a range of 0.040 to 0.072. In order to determine that the inclination value of the subject is obtained from a detrusor overactive patient or a high-risk person thereof, the inclination value of the subject is set to 0.031 to 0.091. And comparing with the range of
A method for assisting determination of bladder perception enhancement and / or detrusor overactivity which is a dysuria .