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TerminatedNCT00713908Updated Dec 16, 2009

Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

An observational study in Voiding Dysfunction, sponsored by University of Rochester. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-16.

Sponsored by University of Rochester · Observational

Why this study was terminated
The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Voiding Dysfunction

Keywords

  • Voiding dysfunction following TVT placement
03

In context

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Urogynecology clinic

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
06

What researchers measure

Primary outcomes

  1. Post-void residual volume

    Time frame: Pre-operative and post-operative periods

Secondary outcomes

  1. 2-day voiding diary, uroflow, standardized questionnaires

    Time frame: Pre-operatively and post-operatively

07

Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00713908
Lead sponsor
University of Rochester
First posted
Jul 14, 2008
Start date
Nov 2007
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Dec 16, 2009

Study contacts

Michael K. Flynn, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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