Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT03831217
• Lead Sponsor: Ankara University

Brief Summary

The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.

Detailed Description

Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.

Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-10-15
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-15
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

• Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
• Patients come to follow up

Exclusion Criteria

• inability in verbal and written communication
• impairment in cognitive functions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective cure rates	1-11 years	Objective cure is negative cough stress test.
Subjective cure rates	1-11 years	Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	1-11 years	Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated.
Tape localization	1-11 years	Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated
Quality of life(QoL) after surgery	1-11 years	Impact of surgery on quality of life will be evaluated by QoL questionnaire

Trial Locations

Locations (1)

Kaan Baydemir; 🇹🇷 Ankara, Çankaya, Turkey