A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Study Overview
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Brief Summary
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This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.

Official Title
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A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence

Conditions
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Stress Urinary Incontinence, Urgency Urinary Incontinence

Intervention / Treatment
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* Drug: solifenacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are selected from those who meets one of criteria Patients with a positive cough provocation test Based on 3-day voiding diary, patients with: Urinary frequency (eight or more micturitions per day or 24 hours) Urinary urgency (two or more episodes per day or 24 hours) Urge incontinence (three or more episodes for 3 days) Exclusion Criteria: Breast-feeding women or females of childbearing potential with the intention to become pregnant during the study Post-void residual urine volume (PRV) of 150 cc or more Patients who experienced acute ureteral obstruction requiring an indwelling catheter Patients who experienced clinically significant pelvic organ prolapse or lower urinary tract surgery within 6 months prior to the initiation of the present study Patients who underwent a urinary incontinence operation within 1 year Any condition that, in the opinion of the investigator, is a contraindication for anticholinergic treatment, including severe narrow-angled glaucoma, urinary retention, gastric retention, severe myasthenia, severe hepatic insufficiency or severe ulcerative colitis Significant hepatic or renal disease, defined as having greater than twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine Patients who have any of neurological disorders such as stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease Patients who use an indwelling catheter or practice intermittent self-catheterization Recurrent UTIs defined as having been treated for symptomatic UTIs 3 times or more in the last year Symptomatic acute urinary tract infection (UTI) during the run-in period Patients who received any of the following prohibited concomitant drugs within 14 days prior to randomization: Treatment performed within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergics other than the trial drug Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed Patients taking an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study Patients with chronic constipation or history of severe constipation Treatment with any of potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole) Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study initiation and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives, surgical procedures (tubal ligation or vasectomy), or continence Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Solifenacin group<br>Once daily | Drug: solifenacin<br>* oral<br>* Other names: Vesicare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12 |  | Baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in the mean number of urge urinary incontinence episodes per 24 hours |  | Baseline, week 4 and week 12 | 
| Change in the mean number of urge urinary incontinence episodes per 24 hours | urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary | Baseline, week 4 and week 12 | 
| Change in the mean frequency of urination per 24 hours |  | Baseline, week 4 and week 12 | 
| Percent change in the mean frequency of urination |  | Baseline, week 4 and week 12 | 
| Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours |  | Baseline, week 4 and week 12 | 
| Change in the mean number of severe urgency episodes per 24 hours | severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary | Baseline, week 4 and week 12 | 
| Changes in overactive bladder symptom score (OABSS) questionnaire | Change in total and each of OABSS items | Baseline, week 4 and week 12 | 
| Changes in short urogenital distress inventory (UDI-6) | Change in total and each UDI-6 items | Baseline, week 4 and week 12 | 
| Changes in short incontinence impact questionnaire (IIQ-7) | Change in total and each of IIQ-7 items | Baseline, week 4 and week 12 | 
| Safety assessed by the incidence and severity of side effects |  | For 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solifenacin, bladder symptom