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Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

NCT ID: NCT00713908

Last Updated: 2009-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Voiding Dysfunction

Keywords

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Voiding dysfunction following TVT placement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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University of Rochester

Principal Investigators

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Michael K. Flynn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20430

Identifier Type: -

Identifier Source: org_study_id