Voiding Dysfunction in the Postoperative Period Following Placement of the TVT

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00713908

Enrollment

Registered

2008-07-14

Start date

2007-11-30

Completion date

2009-08-31

Last updated

2009-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Voiding Dysfunction

Keywords

Voiding dysfunction following TVT placement

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Post-void residual volume	Pre-operative and post-operative periods

Secondary

Measure	Time frame
2-day voiding diary, uroflow, standardized questionnaires	Pre-operatively and post-operatively

Countries

United States

Outcome results