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

June 13, 2016 updated by: Jeong Gu Lee

A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chonam, Korea, Republic of
        • Site KR00001
      • Chungnam, Korea, Republic of
        • Site KR00002
      • Daegu, Korea, Republic of
        • Site KR00003
      • Incheon, Korea, Republic of
        • Site KR00004
      • Pusan, Korea, Republic of
        • Site KR00005
      • Seoul, Korea, Republic of
        • Site KR00006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solifenacin group
Once daily
oral
Other Names:
  • Vesicare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12
Time Frame: Baseline and week 12
Baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in the mean number of urge urinary incontinence episodes per 24 hours
Time Frame: Baseline, week 4 and week 12
Baseline, week 4 and week 12
Change in the mean number of urge urinary incontinence episodes per 24 hours
Time Frame: Baseline, week 4 and week 12
urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary
Baseline, week 4 and week 12
Change in the mean frequency of urination per 24 hours
Time Frame: Baseline, week 4 and week 12
Baseline, week 4 and week 12
Percent change in the mean frequency of urination
Time Frame: Baseline, week 4 and week 12
Baseline, week 4 and week 12
Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours
Time Frame: Baseline, week 4 and week 12
Baseline, week 4 and week 12
Change in the mean number of severe urgency episodes per 24 hours
Time Frame: Baseline, week 4 and week 12
severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary
Baseline, week 4 and week 12
Changes in overactive bladder symptom score (OABSS) questionnaire
Time Frame: Baseline, week 4 and week 12
Change in total and each of OABSS items
Baseline, week 4 and week 12
Changes in short urogenital distress inventory (UDI-6)
Time Frame: Baseline, week 4 and week 12
Change in total and each UDI-6 items
Baseline, week 4 and week 12
Changes in short incontinence impact questionnaire (IIQ-7)
Time Frame: Baseline, week 4 and week 12
Change in total and each of IIQ-7 items
Baseline, week 4 and week 12
Safety assessed by the incidence and severity of side effects
Time Frame: For 12 weeks
For 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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