A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence
- Conditions
- Stress Urinary IncontinenceUrgency Urinary Incontinence
- Interventions
- Registration Number
- NCT01505439
- Lead Sponsor
- Jeong Gu Lee
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 311
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Patients are selected from those who meets one of criteria
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Patients with a positive cough provocation test
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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)
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Breast-feeding women or females of childbearing potential with the intention to become pregnant during the study
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Post-void residual urine volume (PRV) of 150 cc or more
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Patients who experienced acute ureteral obstruction requiring an indwelling catheter
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Patients who experienced clinically significant pelvic organ prolapse or lower urinary tract surgery within 6 months prior to the initiation of the present study
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Patients who underwent a urinary incontinence operation within 1 year
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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
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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
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Patients who have any of neurological disorders such as stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease
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Patients who use an indwelling catheter or practice intermittent self-catheterization
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Recurrent UTIs defined as having been treated for symptomatic UTIs 3 times or more in the last year
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Symptomatic acute urinary tract infection (UTI) during the run-in period
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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
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Patients taking an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
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Patients with chronic constipation or history of severe constipation
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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)
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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
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Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Solifenacin group solifenacin Once daily
- Primary Outcome Measures
Name Time Method Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12 Baseline and week 12
- Secondary Outcome Measures
Name Time Method 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 Baseline, week 4 and week 12 urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary
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 Baseline, week 4 and week 12 severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary
Changes in overactive bladder symptom score (OABSS) questionnaire Baseline, week 4 and week 12 Change in total and each of OABSS items
Changes in short urogenital distress inventory (UDI-6) Baseline, week 4 and week 12 Change in total and each UDI-6 items
Changes in short incontinence impact questionnaire (IIQ-7) Baseline, week 4 and week 12 Change in total and each of IIQ-7 items
Safety assessed by the incidence and severity of side effects For 12 weeks
Trial Locations
- Locations (6)
Site KR00005
🇰🇷Pusan, Korea, Republic of
SIte KR00004
🇰🇷Incheon, Korea, Republic of
Site KR00006
🇰🇷Seoul, Korea, Republic of
Site KR00003
🇰🇷Daegu, Korea, Republic of
Site KR00001
🇰🇷Chonam, Korea, Republic of
Site KR00002
🇰🇷Chungnam, Korea, Republic of