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

NCT01505439 | Completed Phase 4

• 1 other identifier: VENUS-MUI
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 6

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

Keywords

solifenacin; bladder symptom

Outcome Measures

Primary Outcomes (1)

• Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12

  Baseline and week 12

Secondary Outcomes (10)

• 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

• 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

Study Arms (1)

Solifenacin group

EXPERIMENTAL

Once daily

Drug: solifenacin

Interventions

solifenacin DRUG

oral

Also known as: Vesicare

Solifenacin group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jeong Gu Lee: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (6)

Site KR00003

Daegu, South Korea

Location

SIte KR00004

Incheon, South Korea

Location

Site KR00001

Jeonam, South Korea

Location

Site KR00002

Jungnam, South Korea

Location

Site KR00005

Pusan, South Korea

Location

Site KR00006

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

KR (6)