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NCT02337374 Clinical Trial

Predictive Role of Urodynamics on Mid-urethral Sling Failure

Urinary Incontinence, Stress Clinical Trial

— UPMUSF  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02337374
Other study ID # KSSRTH2010-06
Secondary ID
Status Completed
Phase N/A
First received January 9, 2015
Last updated January 9, 2015
Start date June 2010

Study information
Verified date January 2015
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 242
Est. completion date
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Midurethral sling mesh

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Mid urethral sling surgery failure after june 2010 No
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