Over Active Bladder Patients Having Sling Surgery

NCT00852696 | Terminated Results

• 1 other identifier: 8867
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Incontinence; Solifenacin; Women; Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  9 weeks

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Placebo Orally 9 weeks once daily.

Other: Placebo

Solifenacin Group

EXPERIMENTAL

Solifenacin Orally 9 weeks once daily.

Drug: Solifenacin

Interventions

Solifenacin 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.

Also known as: Tolterodine Tartrate

Solifenacin Group

Placebo OTHER

Take orally once daily for 9 weeks.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland Clinic Florida: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Cecilia Calvo
• Organization: Cleveland Clinic Florida

calvoc@ccf.org

954-659-5637

Study Officials

• G W Davila, MD

  Cleeland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)