Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

This study is currently recruiting participants.

Verified by University of Rochester, September 2008

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00713908

Purpose

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
Voiding Dysfunction

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Post-void residual volume [ Time Frame: Pre-operative and post-operative periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

2-day voiding diary, uroflow, standardized questionnaires [ Time Frame: Pre-operatively and post-operatively ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Urogynecology clinic

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713908

Contacts

Contact: Mare Perevich, RN, CCRC

585-273-2996

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Mare Perevich, RN, CCRC 585-273-2996
Principal Investigator: Michael K. Flynn, MD

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Michael K. Flynn, MD

University of Rochester

More Information

Responsible Party:	University of Rochester ( Michael K. Flynn, MD )
Study ID Numbers:	20430
Study First Received:	July 8, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00713908
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Voiding dysfunction following TVT placement

ClinicalTrials.gov processed this record on January 14, 2009