Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00713908
First received: July 8, 2008
Last updated: December 15, 2009
Last verified: December 2009
History of Changes
  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:

U.S. FDA Resources

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 ]
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 8, 2008
Last Updated: December 15, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016