Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochlo… (NCT01942681) | Clinical Trial Compass
CompletedNot Applicable
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
Japan62 participantsStarted 2013-09
Plain-language summary
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.
Who can participate
Age range20 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕
What they're measuring
1
Occurrence of incontinence
Timeframe: during a twelve-week treatment period
Trial details
NCT IDNCT01942681
SponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan