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Clinical Trials/NCT02337374
NCT02337374CompletedNot Applicable

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

Kanuni Sultan Suleyman Training and Research Hospital0 sites242 target enrollmentStarted: June 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
242
Primary Endpoint
Mid urethral sling surgery failure

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mid urethral sling surgery failure

Time Frame: after june 2010

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

serdar aydin

MD

Kanuni Sultan Suleyman Training and Research Hospital

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