NCT06912880

Effects of Therapies in Women With Stress Urinary Incontinence

Effects Of Surgical and Medical Therapy on Psychosocial, Quality Of Life and Social Participation in Women With Stress Urinary Incontinence

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Eastern Mediterranean University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Purpose: This study aims to evaluate how surgical and medical treatments affect quality of life, depression status, and social participation in women with stress urinary incontinence (SUI). Methods: The study includes 32 women diagnosed with SUI. Participants are divided into two groups: 16 receiving medical treatment and 16 undergoing surgical treatment. All participants are evaluated before treatment and 8 weeks after its completion using the following instruments: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Incontinence Quality of Life Questionnaire (I-QOL), World Health Organization Quality of Life Instrument-Short Form (WHOQOL-BREF), Beck Depression Inventory (BDI), and Social Participation Questionnaire (SPQ).

Detailed description

This study was approved by the Çukurova University Institute of Health Sciences Non-Interventional Clinical Studies Ethics Committee (Meeting no. 70, November 10, 2017, File no. 29). All procedures were conducted in accordance with the Declaration of Helsinki. Written and verbal informed consent was obtained from all participants after explaining the study's purpose and procedures. Sample size was calculated using G\*Power 3.1 software (Universität Düsseldorf, Germany). Based on previous literature, the sample was powered to detect a within-group change on the Incontinence Quality of Life Questionnaire (I-QOL), with at least 16 participants required per group to achieve 80% power and a 95% confidence interval. Necessary permissions were obtained from the hospital's urology outpatient clinic prior to data collection. A total of 32 women over the age of 18, newly diagnosed with stress urinary incontinence (SUI) and with symptoms lasting for more than 6 months, were included. Exclusion criteria included: history of vaginal or pelvic surgery within the past 6 months, current or recurrent urinary tract infections (more than 3 in the last year), neurological or neuromuscular disease (e.g., cerebrovascular accident, Alzheimer's disease, spinal cord injury, or dementia), kidney or liver failure, illiteracy, or inability to participate in evaluations or communication. Participants were assigned to treatment by their physicians, either medical (n=16) or surgical (n=16). The medical group received pharmacological treatment, while the surgical group underwent the Transobturator Tape (TOT) procedure. Evaluations were conducted face-to-face by the same physiotherapist before treatment and 8 weeks after treatment using standardized questionnaires: ICIQ-SF, I-QOL, WHOQOL-BREF, BDI, and SPQ.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	trans obturator tape surgery	Trans-obturator technique is a more beneficial and a less invasive procedure in treatment of SUI when compared with other techiniques. In this technique, a synthetic mesh tape, which is passing bilaterally through the obturator foramen, is placed underneath the mid part of the urethra.

Timeline

• Start date: 2017-11-09
• Primary completion: 2018-03-30
• Completion: 2018-04-30
• First posted: 2025-04-06
• Last updated: 2025-04-08

Locations

1 site across 1 country: Turkey (Türkiye)