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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeong Gu Lee
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Solifenacin Succinate

Criteria

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