Effects of Therapies in Women With Stress Urinary Incontinence

NCT06912880 | Completed

• 1 other identifier: November 10,2017
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Urinary Incontinence

Keywords

quality of life; social participation; women; incontinence

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Interventions

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.

the surgical treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women with diagnoses of stress urinary incontinence.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Adana State Hospital

Adana, Çukurova, 01360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Berkiye Kırmızıgil, Asst. Prof.

  Eastern Mediterranean University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: April 6, 2025
• Study Start: November 9, 2017
• Primary Completion: March 30, 2018
• Study Completion: April 30, 2018
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

TU (1)