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

NCT ID: NCT01505439

Last Updated: 2016-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Stress Urinary Incontinence; Urgency Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin group

Once daily

Group Type: EXPERIMENTAL

solifenacin

Intervention Type: DRUG

oral

Interventions

solifenacin

oral

Intervention Type: DRUG

Other Intervention Names

Vesicare

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: collaborator

Jeong Gu Lee

OTHER

Sponsor Role: lead

Responsible Party

Jeong Gu Lee

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Site KR00003

Daegu, , South Korea

SIte KR00004

Incheon, , South Korea

Site KR00001

Jeonam, , South Korea

Site KR00002

Jungnam, , South Korea

Site KR00005

Pusan, , South Korea

Site KR00006

Seoul, , South Korea

Countries

South Korea

Other Identifiers

VENUS-MUI

Identifier Type: -

Identifier Source: org_study_id