NCT00713908

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 16, 2009

Status Verified

December 1, 2009

Enrollment Period

1.8 years

First QC Date

July 8, 2008

Last Update Submit

December 15, 2009

Conditions

Voiding Dysfunction

Keywords

Voiding dysfunction following TVT placement

Outcome Measures

Primary Outcomes (1)

  • Post-void residual volume

    Pre-operative and post-operative periods

Secondary Outcomes (1)

  • 2-day voiding diary, uroflow, standardized questionnaires

    Pre-operatively and post-operatively

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Urogynecology clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Study Officials

  • Michael K. Flynn, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

November 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 16, 2009

Record last verified: 2009-12

Locations

US(1)