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Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

This study has been terminated.
(The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713908
First Posted: July 14, 2008
Last Update Posted: December 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Rochester
  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

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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Post-void residual volume [ Time Frame: Pre-operative and post-operative periods ]

Secondary Outcome Measures:
  • 2-day voiding diary, uroflow, standardized questionnaires [ Time Frame: Pre-operatively and post-operatively ]

Enrollment: 2
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713908


Locations
United States, New York
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
  More Information

Responsible Party: Michael K. Flynn, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00713908     History of Changes
Other Study ID Numbers: 20430
First Submitted: July 8, 2008
First Posted: July 14, 2008
Last Update Posted: December 16, 2009
Last Verified: December 2009

Keywords provided by University of Rochester:
Voiding dysfunction following TVT placement