Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00821184
• Other study ID #: 2006-083
• Status: Terminated
• Phase: Phase 3
• First received: January 9, 2009
• Last updated: March 8, 2018
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: March 2018
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Description:

Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Intervention

Drug:
• Vesicare (solifenacin)
5mg po qd

Behavioral:
• Vesicare (solifenacin) plus behavioral modification
5 mg dose po once daily plus behavioral modification

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Lahey Clinic	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.		0 week - 12 weeks
Secondary	Improvement of Symptom Severity		3 months