Predictive Role of Urodynamics on Mid-urethral Sling Failure

NCT ID: NCT02337374

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 242 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30

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.

Conditions

Urinary Incontinence, Stress

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Midurethral sling mesh

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

serdar aydin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KSSRTH2010-06

Identifier Type: -

Identifier Source: org_study_id