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

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).

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: trans obturator tape surgery

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Turkey
  • Çukurova
    • Adana, Çukurova, Turkey, 01360
      • Adana State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A total of 32 female patients over the age of 18, who were newly diagnosed with SUI and had symptoms ongoing for over 6 months were included in the study. 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disease-Specific Quality of Life Score (I-QOL)	Disease-specific quality of life will be assessed using the Incontinence Quality of Life Questionnaire (I-QOL). This is a 22-item questionnaire scored on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better quality of life.	Change from Baseline (Week 0) to Post-treatment (Week 8)
Change in General Quality of Life Score (WHOQOL-BREF)	General quality of life will be evaluated using the World Health Organization Quality of Life Instrument - Short Form (WHOQOL-BREF). The WHOQOL-BREF includes 26 items across four domains: physical, psychological, social, and environmental. Each domain is scored separately, with scores ranging from 0 to 100, where higher scores indicate better perceived quality of life.	Change from Baseline (Week 0) to Post-treatment (Week 8)
depression	Evaluation of Depression: Depression levels will be measured using the Beck Depression Inventory, a 21-item self-report instrument. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.	At the beginning and at the end of 8 weeks
community participation	Evaluation of Community Participation: The Social Participation Questionnaire was used to assess the extent the subjects actively took part in life activities and how active they were. The Social Participation Questionnaire consists of 15 items. Community participation will be evaluated using the Social Participation Questionnaire (SPQ), which includes 15 items covering domains such as home and family life, social activities, and work. Scores range from 0 to 90, with higher scores indicating greater levels of social participation.	At the beginning and at the end of 8 weeks

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Chair: Berkiye Kırmızıgil, Asst. Prof., Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; women; incontinence; social participation
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: November 10,2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No