Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Voiding Dysfunction Clinical Trial

Official title:

Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00713908
• Other study ID #: 20430
• Status: Terminated
• Phase: N/A
• First received: July 8, 2008
• Last updated: December 15, 2009
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: December 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Voiding Dysfunction

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-void residual volume		Pre-operative and post-operative periods	No
Secondary	2-day voiding diary, uroflow, standardized questionnaires		Pre-operatively and post-operatively	No