Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.

Official Title
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Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Drug: Propiverine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with mixed urinary incontinence (MUI) Patients having symptoms of urinary incontinence for at least 3 months Patients having at least one episode of urge urinary incontinence per week and 4 episodes of stress urinary incontinence per week in a bladder diary. 20 years old or older Patients who meet all the following criteria in ICIQ-SF (1) 2-3 times or more in one week was selected at Q1. (2) Small or more was selected at Q2. (3) leak at the time of cough or sneeze or leak at the time of exercise was selected at Q4. Less than 100mL of residual urine volume Written informed consent. Exclusion Criteria: Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis) Patients with advanced lower urinary tract obstruction or urinary retention Patients without urinary sensation Patients with overflow incontinence Patients with history or complications of pelvic organ prolapse Patients with pyloric, duodenal or intestinal obstruction Patients with gastric or intestinal atony Patients with angle-closure glaucoma Patients with myasthenia gravis Patients with severe heart disease Patients with severe constipation Patients with dementia who are not able to complete the questionnaires Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine Patients with history of surgery that affect urination such as Trans-Obturator Tape（TOT）or Tension-free Vaginal Tape（TVT） Women who are pregnant, lactating, potentially pregnant or willing to get pregnant Patients with previous surgery of the abdomen and pelvis or radiation within 6 months Patients who started pelvic floor muscle exercise within 3 months Patients who took Propiverine Hydrochloride or other similar medicine within 2 weeks before entry Judged as being unsuitable for the trial by physician.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Propiverine Hydrochloride Administration<br>Administration of Propiverine Hydrochloride for 12 weeks | Drug: Propiverine Hydrochloride<br>* Administrate Propiverine Hydrochloride for 12 weeks<br>* Other names: Bup-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of incontinence | Change in occurrence of incontinence during a twelve-week treatment | during a twelve-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of protective pad used | Change in the number of protective pad used during a twelve-week treatment period | during a twelve-week treatment period | 
| Reduction ratio of the occurrence for incontinence | Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period | during a twelve-week treatment period | 
| ICIQ-Short Form(SF) scores | Change in ICIQ-SF scores during a twelve-week treatment period | during a twelve-week treatment period | 
| I-QOL scores | Change in I-QOL scores during a twelve-week treatment period | during a twelve-week treatment period | 
| IPSS-QOL scores | Change in IPSS-QOL scores during a twelve-week treatment period | during a twelve-week treatment period | 
| IPSS symptom scores | Change in IPSS symptom scores during a twelve-week treatment period | during a twelve-week treatment period | 
| OABSS symptom scores | Change in OABSS symptom scores during a twelve-week treatment period | during a twelve-week treatment period | 
| Blood pressure | Change in blood pressure during a twelve-week treatment period | during a twelve-week treatment period | 
| Pulse rate | Change in pulse rate during a twelve-week treatment period | during a twelve-week treatment period | 
| Safety assessment | The occurrence of adverse events during a twelve-week treatment period | during a twelve-week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, mixed urinary incontinence