Effects of Therapies in Women With Stress Urinary Incontinence

NCT ID: NCT06912880

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2018-04-30

Brief 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

Study Design

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

Study Groups

the medical treatment group

16 female Stress Urinary Incontinence patients considered for medical treatment as anticholinergic combinations their doctors and met the inclusion criteria of the study were assessed immediately before the treatment and 8 weeks after their medical treatment. The subjects in the medical treatment group received medication procedure. All patient assessments were performed face to face by the same physiotherapist.

No interventions assigned to this group

the surgical treatment group

In the surgical treatment group 16 female Stress Urinary Incontinence patients underwent the Transobturator Tape (TOT) procedure. All patient assessments were performed face to face by the same physiotherapist.

trans obturator tape surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed with Stress Urinary Incontinence
• had symptoms ongoing for over 6 months.

Exclusion Criteria

• Cases were excluded if the individual had a vaginal or pelvic operation in the last 6 months,
• an active urinary tract infection or more than 3 urinary tract infections in the past year
• a neurological or neuromuscular disease (cerebrovascular accident, Alzheimer's, spinal cord injury, or dementia), kidney or liver failure, or was illiterate or in a condition to prevent evaluation or communication.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Burçin Uğur Tosun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berkiye Kırmızıgil, Asst. Prof.

Role: STUDY_CHAIR

Eastern Mediterranean University

Locations

Adana State Hospital

Adana, Çukurova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

November 10,2017

Identifier Type: -

Identifier Source: org_study_id