Status:
COMPLETED
A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence
Lead Sponsor:
Jeong Gu Lee
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Stress Urinary Incontinence
Urgency Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01505439
Start Date
June 1 2011
End Date
June 1 2014
Last Update
June 15 2016
Active Locations (6)
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1
Site KR00003
Daegu, South Korea
2
SIte KR00004
Incheon, South Korea
3
Site KR00001
Jeonam, South Korea
4
Site KR00002
Jungnam, South Korea