- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01505439
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
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Incheon, Korea, Republic of
- Site KR00004
-
Pusan, Korea, Republic of
- Site KR00005
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Seoul, Korea, Republic of
- Site KR00006
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-
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:
|
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.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
Other Study ID Numbers
- VENUS-MUI
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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Hanmi Pharmaceutical Company LimitedCompleted
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Astellas Pharma Europe B.V.CompletedUrinary Bladder, OveractiveBelgium, United States, Brazil, Canada, Denmark, Former Serbia and Montenegro, Korea, Republic of, Mexico, Norway, Philippines, Poland, South Africa, Sweden, Turkey, Ukraine, United Kingdom
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