Over Active Bladder Patients Having Sling Surgery

NCT ID: NCT00852696

Last Updated: 2022-07-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Group

Placebo Orally 9 weeks once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Take orally once daily for 9 weeks.

Solifenacin Group

Solifenacin Orally 9 weeks once daily.

Group Type EXPERIMENTAL

Solifenacin

Intervention Type DRUG

Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.

Interventions

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Solifenacin

Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.

Intervention Type DRUG

Placebo

Take orally once daily for 9 weeks.

Intervention Type OTHER

Other Intervention Names

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Tolterodine Tartrate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Cleveland Clinic Florida

OTHER

Sponsor Role lead

Responsible Party

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Eric Hurtado

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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G W Davila, MD

Role: PRINCIPAL_INVESTIGATOR

Cleeland Clinic

Locations

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Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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8867

Identifier Type: -

Identifier Source: org_study_id

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