Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
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ClinicalTrials.gov Identifier: NCT00821184 |
Recruitment Status :
Terminated
(Insufficient subject availability/findings for data analysis)
First Posted : January 13, 2009
Results First Posted : July 30, 2010
Last Update Posted : April 4, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overactive Bladder | Drug: Vesicare (solifenacin) Behavioral: Vesicare (solifenacin) plus behavioral modification | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vesicare
Vesicare alone
|
Drug: Vesicare (solifenacin)
5mg po qd |
Active Comparator: Vesicare/behavioral modification
Vesicare plus behavioral modification
|
Behavioral: Vesicare (solifenacin) plus behavioral modification
5 mg dose po once daily plus behavioral modification
Other Name: Vesicare (solifenacin) |
- Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. [ Time Frame: 0 week - 12 weeks ]
- Improvement of Symptom Severity [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female patients > 18 years of age
- OAB symptoms for > 3 months
- Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
- May or may not be accompanied by urinary frequency
- May be accompanied by stress urinary incontinence where stress incontinence does not predominate
Exclusion Criteria:
- Male Patients
- Underlying cortical or spinal cord pathology including SCI, MS, or
- Parkinson's Disease
- Urinary retention with post-void residual > 150cc
- Current treatment or treatment within the last 3 months with anticholinergic medications
- Patients not able to complete the questionaires or voiding diaries in English
- Pregnancy
- Active urinary tract infections
- Bladder Cancer or unevaluated hematuria
- Known diagnosis of narrow angle glaucoma
- Severe constipation
- History of reduced renal function (CrCl<30ml/min)
- History of liver disease
- Current treatment with cytochrome P450 inhibitor medications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821184
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 |
Principal Investigator: | John T Stoffel, M.D. | Lahey Clinic |
Responsible Party: | Linda Topjian, Study Coordinator, Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00821184 |
Other Study ID Numbers: |
2006-083 |
First Posted: | January 13, 2009 Key Record Dates |
Results First Posted: | July 30, 2010 |
Last Update Posted: | April 4, 2018 |
Last Verified: | March 2018 |
urinary incontinence overactive bladder urinary frequency |
Urinary Bladder, Overactive Urinary Incontinence, Urge Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Urinary Incontinence Urination Disorders |
Solifenacin Succinate Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |