Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Tolterodine Tartrate; Trospium chloride

Criteria

Inclusion Criteria:

• Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification

• Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence

• Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

Exclusion Criteria:

• Predominant stress or insensate incontinence

• History of neurogenic bladder

• Two urinary tract infections in the last six months

• Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)

• Donated >500mL blood in the 30 days prior to the screening visit