Over Active Bladder Patients Having Sling Surgery

NeuroTherapia, Inc.

Status: Terminated

Conditions: Overactive Bladder

Treatments: Other: Placebo; Drug: Solifenacin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00852696

8867

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.

Full description

Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >/= 18
• Patient is appropriate for sub-urethral sling procedure
• Mixed urinary incontinence
• No antimuscarinic therapy for previous 30 days

Exclusion criteria

• Uncontrolled narrow angle glaucoma
• Acute cystitis
• Unevaluated hematuria
• Currently using anti-muscarinic therapy
• Unable to complete pre-operative urodynamics
• Contraindication to anti-cholinergic therapy
• Unable or unwilling to complete diaries or quality of life questionaire
• Significant (exteriorized) Pelvic Organ Prolapse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo Orally 9 weeks once daily.

Treatment:

Other: Placebo

Solifenacin Group

Experimental group

Description:

Solifenacin Orally 9 weeks once daily.

Treatment:

Drug: Solifenacin