Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

Stress Urinary Incontinence Clinical Trial

Official title:

Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831217
• Other study ID #: 29081991
• Status: Completed
• Start date: October 15, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: February 2019
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 15, 2020
• Est. primary completion date: June 1, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• mid urethral sling surgery
patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.

Locations

Country	Name	City	State
Turkey	Kaan Baydemir	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective cure rates	Objective cure is negative cough stress test.	1-11 years
Primary	Subjective cure rates	Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.	1-11 years
Secondary	Tape localization	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	1-11 years
Secondary	Quality of life(QoL) after surgery	Impact of surgery on quality of life will be evaluated by QoL questionnaire	1-11 years
Secondary	Patient satisfaction	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.	1-11 years