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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:
University of Rochester
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00713908
First received: July 8, 2008
Last updated: December 15, 2009
Last verified: December 2009
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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| 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
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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
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 |
Keywords provided by University of Rochester:
|
Voiding dysfunction following TVT placement |
ClinicalTrials.gov processed this record on August 16, 2017