UPMUSF: Predictive Role of Urodynamics on Mid-urethral Sling Failure

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02337374

Collaborator

(none)

242

Enrollment

Study Details

Study Description

Brief Summary

Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Stress	Device: Midurethral sling mesh

Study Design

Study Type:

Observational

Actual Enrollment :

242 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Do Urodynamics Superior to 25 Years of Clinical Expertise Predict Mid-Urethral Sling Failure?

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Outcome Measures

Primary Outcome Measures

Mid urethral sling surgery failure [after june 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test

Exclusion Criteria:

prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to surgery