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Completed

NCT Number: NCT06912880

Effects of Therapies 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).

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Adana State Hospital

Adana, Çukurova, 01360, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trans obturator tape surgery

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.

Primary outcomes

  1. Change in Disease-Specific Quality of Life Score (I-QOL)

    Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8)

    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.

  2. Change in General Quality of Life Score (WHOQOL-BREF)

    Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8)

    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.

  3. depression

    Time frame: At the beginning and at the end of 8 weeks

    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.

  4. community participation

    Time frame: At the beginning and at the end of 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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