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Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Sponsor
University of Rochester (Other)
Overall Status
Terminated
CT.gov ID
NCT00713908
Collaborator
(none)
2
Enrollment
1
Location
21
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate how often women have problems passing their urine (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better understand normal voiding function after surgery as well as to find factors that may help us predict who will have problems after surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Voiding Dysfunction in the Postoperative Period Following Placement of the TVT
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Aug 1, 2009
    Actual Study Completion Date :
    Aug 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. Post-void residual volume [Pre-operative and post-operative periods]

    Secondary Outcome Measures

    1. 2-day voiding diary, uroflow, standardized questionnaires [Pre-operatively and post-operatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnosis of stress incontinence, diagnosis must be confirmed by cough stress test or multichannel urodynamics

    • Undergoing minimally invasive sling procedure - TVT (by transvaginal or surpapubic approach)

    • Must be competent to give informed consent

    Exclusion Criteria:

    • No diagnosis of stress urinary incontinence

    • Undergoing minimally invasive sling procedure by route other than TVT

    • Undergoing any other pelvic organ prolapse repair procedures

    • Pregnancy

    • Known voiding dysfunction preoperatively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    • Principal Investigator: Michael K. Flynn, MD, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00713908
    Other Study ID Numbers:
    • 20430
    First Posted:
    Jul 14, 2008
    Last Update Posted:
    Dec 16, 2009
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    Voiding dysfunction following TVT placement

    Study Results

    No Results Posted as of Dec 16, 2009