Clinical trial NCT06912880: Effects of Therapies in Women With Stress Urinary Incontinence
Official title: Effects Of Surgical and Medical Therapy on Psychosocial, Quality Of Life and Social Participation in Women With Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: quality of life
social participation
women
incontinence
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change in Disease-Specific Quality of Life Score (I-QOL)
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8)
measure: Change in General Quality of Life Score (WHOQOL-BREF)
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8)
measure: depression
timeFrame: At the beginning and at the end of 8 weeks
measure: community participation
timeFrame: At the beginning and at the end of 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana State Hospital
state: Çukurova
Study officials:
affiliation: Eastern Mediterranean University
name: Berkiye Kırmızıgil, Asst. Prof.
role: STUDY_CHAIR
References: