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Over Active Bladder Patients Having Sling Surgery

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00852696
First received: February 26, 2009
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
 Drug: Solifenacin
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • To assess the efficacy of solifenacin in the prevention of postoperative OAB symptoms (urinary frequency,urgency, urge incontinence, nocturia) in women undergoing sub-urethral sling placement for mixed urinary incontinence with primary stress symptoms. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess safety of Solifenacin in women having sub-urethral sling procedures, the perioperative period, on quality of life measures on length of hospitalization on the time to resumption of normal voiding in time to removal of suprapubic catheter. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Orally 9 weeks once daily.
 Other: Placebo
Take orally once daily for 9 weeks.
Experimental: Solifenacin
Orally 9 weeks once daily.
 Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852696

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Astellas Pharma US, Inc.
  More Information

No publications provided

Responsible Party: Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00852696     History of Changes
Other Study ID Numbers: 8867
Study First Received: February 26, 2009
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:
Overactive Bladder
Incontinence
Solifenacin
Women
Postoperative

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013