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Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

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ClinicalTrials.gov Identifier: NCT00713908
Recruitment Status : Terminated (The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.)
First Posted : July 14, 2008
Last Update Posted : December 16, 2009
Sponsor:
Information provided by:
University of Rochester

Study Description
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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
Voiding Dysfunction

Study Design
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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 : November 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Post-void residual volume [ Time Frame: Pre-operative and post-operative periods ]

Secondary Outcome Measures :
  1. 2-day voiding diary, uroflow, standardized questionnaires [ Time Frame: Pre-operatively and post-operatively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Responsible Party: Michael K. Flynn, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00713908     History of Changes
Other Study ID Numbers: 20430
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: December 2009

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