Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Allergan

Status and phase: Completed; Phase 4

Conditions: Obesity; Incontinence; Overactive Bladder

Treatments: Drug: Trospium Chloride, Extended Release (XR); Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932022

Sanctura XR obesity OAB Trial (Other Identifier)

MA-SXR-09-003

Details and patient eligibility

About

This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.

Enrollment: 127 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
• Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
• Obese

Exclusion criteria

• Chronic kidney failure
• Abdominal bypass surgery for obesity
• Moderate or severe memory impairment
• Uncontrolled narrow angle glaucoma
• Uncontrolled systemic disease
• Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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127 participants in 2 patient groups, including a placebo group

trospium chloride XR 60 mg

Experimental group

Description:

Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.

Treatment:

Other: placebo

Drug: Trospium Chloride, Extended Release (XR)

placebo

Placebo Comparator group

Description:

Placebo capsule taken orally once daily for 14 weeks.

Treatment:

Other: placebo