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:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Sodium polystyrene sulfonate

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 ]

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

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

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 June 26, 2017

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