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

Lahey Health

Status and phase: Terminated; Phase 3

Conditions: Overactive Bladder

Treatments: Behavioral: Vesicare (solifenacin) plus behavioral modification; Drug: Vesicare (solifenacin)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00821184

2006-083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Vesicare

Active Comparator group

Description:

Vesicare alone

Treatment:

Drug: Vesicare (solifenacin)

Vesicare/behavioral modification

Active Comparator group

Description:

Vesicare plus behavioral modification

Treatment:

Behavioral: Vesicare (solifenacin) plus behavioral modification