Stress Urinary IncontinenceNCT06912880
Effects of Therapies in Women With Stress Urinary Incontinence
An observational study of Stress Urinary Incontinence, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- trans obturator tape surgery
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2017to 30 Apr 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Newly diagnosed with Stress Urinary Incontinence
- had symptoms ongoing for over 6 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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).
Read the 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
- Being tested
- trans obturator tape surgery
- Keywords
- quality of life, social participation, women, incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans obturator tape surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: trans obturator tape surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the beginning and at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start9 Nov 2017
- Primary completion30 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Uğur Tosun, Eastern Mediterranean University
- Investigators
- Berkiye Kırmızıgil, Asst. Prof., Study chair, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912880
- Sponsor's protocol ID
- November 10,2017
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Surgical and Medical Therapy on Psychosocial, Quality Of Life and Social Participation in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06912880
- Acronym / sponsor ID
- November 10,2017
- Conditions
- Stress Urinary Incontinence
- Keywords
- quality of life, social participation, women, incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: trans obturator tape surgeryIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Newly diagnosed with Stress Urinary Incontinence
- had symptoms ongoing for over 6 months.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trans obturator tape surgeryTrans-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. | Procedure or surgery | the surgical treatment group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berkiye Kırmızıgil, Asst. Prof. study chair
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease-Specific Quality of Life Score (I-QOL) (time frame: Change from Baseline (Week 0) to Post-treatment (Week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.