Stress Urinary IncontinenceNCT07126080
Effect of Coping Training on Attitudes, Sleep, and Quality of Life in Women With Stress Urinary Incontinence
A study testing Incontinence Coping Training in people with Stress Urinary Incontinence, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of urinary incontinence management training provided to postmenopausal women on their urinary incontinence attitudes, sleep, and quality of life. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Incontinence Coping Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Having entered menopause
- Volunteering to participate in the study
- Having no communication barriers
- Using a smartphone
- Having the WhatsApp application
- Experiencing urine leakage when coughing or sneezing, as defined by the ICS (International Continence Association)
Who cannot join
- Having a communication barrier
- Not having gone through menopause
- Not experiencing urinary incontinence
- Having undergone surgical menopause
- Being obese
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Samsun, 55200
Dilek ÇELİK EREN, 05076976158, dilek-celik-61@hotmail.com
Dilek ÇELİK EREN, Dr.
About this study
Official title: The Effect of Coping Training on Urinary Incontinence Attitudes, Sleep, and Quality of Life in Postmenopausal Women With Stress Urinary Incontinence: A Randomized Controlled Trial
This study aims to examine the effects of urinary incontinence management training provided to postmenopausal women on their urinary incontinence attitudes, sleep, and quality of life.
Hypothesis H1: Following the urinary incontinence management training, there will be an increase in urinary incontinence attitudes, sleep, and quality of life in the women in the experimental group compared to the women in the control group.
Read the detailed description
- Research Model: This study will be conducted using a randomized controlled pretest-posttest control group experimental research design.
- Research Universe/Sample or Study Group: This study will be conducted with postmenopausal women over the age of 45 who attended the Gynecology and Obstetrics Clinic of Ondokuz Mayıs University Health Application and Research Center. The study sample size was calculated using the sample size calculator program. Using the Urinary Incontinence Quality of Life Scale as a reference (12.34 (2.18); 5.43 (1.96)) (Başgöl et al., 2025), the sample size was calculated as 36 participants for the experimental group and 36 participants for the control group, with a 5% margin of error, a 90% confidence interval, and an effect size of 33.332. In addition to the minimum sample size, a sample size of 48 participants was determined for each group, with at least 50% spares, for a total of 96 participants. Randomization Simple randomization will be used to unbiasedly assign 96 women who meet the study criteria to the intervention and control groups. Randomization will be determined computer-aided using the Research Randomizer website (https://www.randomizer.org/). Women in the intervention and control groups will be assigned based on the obtained order.
- Data Collection Tools: A Personal Information Form, the Urinary Incontinence Short Test, the Pittsburgh Sleep Quality Index, and the Urinary Incontinence Quality of Life Scale (I-QOL) will be used to collect data for the study. Personal Information Form: Consists of a total of 21 questions that ask about the women's sociodemographic characteristics such as age, education level, and income, their characteristics related to childbirth, and their experience of urinary incontinence. Urinary Incontinence Attitude Scale: Pittsburg Sleep Quality Index: The scale's validity and reliability studies in Turkey were conducted by Ağargün and colleagues in 1996. The PSQI assesses sleep quality over the past month. The PSQI consists of 24 questions, 19 of which are answered by the individual themselves, and 5 by their spouse or roommate. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score greater than 5 is considered the cut-off score indicating poor sleep quality. The scale's Cronbach's alpha reliability coefficient was found to be 0.804. Urinary Incontinence Quality of Life Scale (I-QOL): The validity and reliability of the I-QOL was performed by Özerdoğan. In the Incontinence Quality of Life Scale, all items are evaluated on a five-item Likert-type scale (1=a lot, 2=quite a bit, 3=moderately, 4=a little, 5=not at all), and the calculated total score is converted to a scale value from 0 to 100 for better understanding. The Incontinence Quality of Life Scale consists of three subscales: restrictive behaviors (items 1, 2, 3, 4, 10, 11, 13, and 20), psychological impact (items 5, 6, 7, 9, 15, 16, 17, 21, and 22), and limitations on social life (items 8, 12, 14, 18, and 19). Higher scores indicate better quality of life than lower scores. Incontinence Short Test: To determine the level of knowledge about incontinence, Branch et al. The Incontinence Short Test, developed by Kara et al. and whose Turkish version was studied by Kara et al., was used. The 14-item test is answered with "Agree," "Disagree," or "Don't Know." The correct answer for items 1, 4, 6, 8, 10, and 11 is "Agree." For the remaining items, the correct answer is "Disagree." A "Don't Know" response is considered incorrect. The total score ranges from 0 to 14, with a higher score indicating a higher level of knowledge and a more positive attitude toward urinary incontinence. Intervention: The women in the experimental group will receive a 4-week training program on coping with urinary incontinence. The content of this training consists of the following topics: • Definition, types, and risk factors for urinary incontinence
- Treatment and prevention of urinary incontinence
- Non-drug management strategies for managing urinary incontinence symptoms (eating and toilet habits, such as limiting caffeinated beverages and being mindful of spicy foods)
- Importance and implementation of Kegel exercises After the training is completed, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also be given post-tests at 1 and 3 months. Training will be conducted individually via an online platform.
- Data Collection Process: Pre-tests will be administered to the women in the experimental and control groups at the clinic.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Incontinence Coping Training
- Keywords
- Postmenopausal, Stress Urinary Incontinence, coping strategies, health quality, Attitude, Sleep Quality
- Medical subject headings
- Urinary Incontinence, Stress, Behavior, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incontinence Coping TrainingBehavioural
Intervention: Women in the experimental group will receive a four-week training program on managing urinary incontinence. The training will cover the following topics:
- Definition, types, and risk factors of urinary incontinence
- Treatment and prevention of urinary incontinence
- Symptoms of urinary incontinence and non-drug management strategies (addressing eating and toilet habits, such as limiting caffeinated beverages and cautioning spicy foods)
- The importance and implementation of Kegel exercises After the training, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also receive post-tests at 1 and 3 months. Training will be conducted individually online.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group-Training in Coping with Incontinence | Experimental | Intervention: Women in the experimental group will receive a four-week training program on managing urinary incontinence. The training will cover the following topics:
* Definition, types, and risk factors of urinary incontinence
* Treatment and prevention of urinary incontinence
* Symptoms of urinary incontinence and non-drug management strategies (addressing eating and toilet habits, such as limiting caffeinated beverages and cautioning spicy foods)
* The importance and implementation of Kegel exercises After the training, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also receive post-tests at 1 and 3 months. Training will be conducted individually online. Receives: Behavioral: Incontinence Coping Training |
| Control Group | No intervention | No ıntervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
It consists of a total of 21 questions asking about women's sociodemographic characteristics such as age, education level, income level, birth-related characteristics and urinary incontinence.
Measured: 4 weeks
The incontinence short test:
A Turkish validity and reliability study was conducted by Kara et al. The test consists of 14 statements and is answered with "Agree," "Disagree," or "Don't Know." The correct answer for statements 1, 4, 6, 8, 10, and 11 is "Agree." The correct answer for the remaining statements is "Disagree." A "Don't Know" response is considered incorrect. The total score ranges from 0 to 14, with higher scores indicating a higher level of knowledge and a more positive attitude toward urinary incontinence.
Measured: 16 weeks
Pittsburgh Sleep Quality Index:
The scale's validity and reliability studies in Turkey were conducted by Ağargün and colleagues in 1996. The PSQI assesses sleep quality over the past month. The PSQI consists of 24 questions, 19 of which are answered by the individual themselves, and 5 by their spouse or roommate. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score of 5 or higher is considered the cut-off score for poor sleep quality. The scale's Cronbach's alpha reliability coefficient was found to be 0.804.
Measured: 16 weeks
Urinary Incontinence Quality of Life Scale (I-QOL):
The validity and reliability of the I-QOL was determined by Özerdoğan. All items in the Incontinence Quality of Life Scale are evaluated on a five-category Likert-type scale (1=a great deal, 2=quite a bit, 3=moderately, 4=a little, 5=not at all), and the calculated total score is converted to a scale value from 0 to 100 for better understanding. The Incontinence Quality of Life Scale consists of three subscales: behavioral limitation (items 1, 2, 3, 4, 10, 11, 13, and 20), psychological impact (items 5, 6, 7, 9, 15, 16, 17, 21, and 22), and social limitation (items 8, 12, 14, 18, and 19). High scores indicate better quality of life than low scores.
Measured: 16 weeks
Personal Information Form
It consists of a total of 21 questions asking about women's sociodemographic characteristics such as age, education level, income level, birth-related characteristics and urinary incontinence.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
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.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled pretest-posttest control group experimental research design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Celi̇k Eren, Ondokuz Mayıs University
- Investigators
- İlknur AYDIN AVCİ, Prof. Dr., Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126080
- Sponsor's protocol ID
- 2025-845
- Other IDs
- There is no funding.
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coping Training on Urinary Incontinence Attitudes, Sleep, and Quality of Life in Postmenopausal Women With Stress Urinary Incontinence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07126080
- Acronym / sponsor ID
- 2025-845
- Conditions
- Stress Urinary Incontinence
- Keywords
- Postmenopausal, Stress Urinary Incontinence, coping strategies, health quality, Attitude, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 17 Aug 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.
This study aims to examine the effects of urinary incontinence management training provided to postmenopausal women on their urinary incontinence attitudes, sleep, and quality of life.
Hypothesis H1: Following the urinary incontinence management training, there will be an increase in urinary incontinence attitudes, sleep, and quality of life in the women in the experimental group compared to the women in the control group.
Detailed description
- Research Model: This study will be conducted using a randomized controlled pretest-posttest control group experimental research design.
- Research Universe/Sample or Study Group: This study will be conducted with postmenopausal women over the age of 45 who attended the Gynecology and Obstetrics Clinic of Ondokuz Mayıs University Health Application and Research Center. The study sample size was calculated using the sample size calculator program. Using the Urinary Incontinence Quality of Life Scale as a reference (12.34 (2.18); 5.43 (1.96)) (Başgöl et al., 2025), the sample size was calculated as 36 participants for the experimental group and 36 participants for the control group, with a 5% margin of error, a 90% confidence interval, and an effect size of 33.332. In addition to the minimum sample size, a sample size of 48 participants was determined for each group, with at least 50% spares, for a total of 96 participants. Randomization Simple randomization will be used to unbiasedly assign 96 women who meet the study criteria to the intervention and control groups. Randomization will be determined computer-aided using the Research Randomizer website (https://www.randomizer.org/). Women in the intervention and control groups will be assigned based on the obtained order.
- Data Collection Tools: A Personal Information Form, the Urinary Incontinence Short Test, the Pittsburgh Sleep Quality Index, and the Urinary Incontinence Quality of Life Scale (I-QOL) will be used to collect data for the study. Personal Information Form: Consists of a total of 21 questions that ask about the women's sociodemographic characteristics such as age, education level, and income, their characteristics related to childbirth, and their experience of urinary incontinence. Urinary Incontinence Attitude Scale: Pittsburg Sleep Quality Index: The scale's validity and reliability studies in Turkey were conducted by Ağargün and colleagues in 1996. The PSQI assesses sleep quality over the past month. The PSQI consists of 24 questions, 19 of which are answered by the individual themselves, and 5 by their spouse or roommate. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score greater than 5 is considered the cut-off score indicating poor sleep quality. The scale's Cronbach's alpha reliability coefficient was found to be 0.804. Urinary Incontinence Quality of Life Scale (I-QOL): The validity and reliability of the I-QOL was performed by Özerdoğan. In the Incontinence Quality of Life Scale, all items are evaluated on a five-item Likert-type scale (1=a lot, 2=quite a bit, 3=moderately, 4=a little, 5=not at all), and the calculated total score is converted to a scale value from 0 to 100 for better understanding. The Incontinence Quality of Life Scale consists of three subscales: restrictive behaviors (items 1, 2, 3, 4, 10, 11, 13, and 20), psychological impact (items 5, 6, 7, 9, 15, 16, 17, 21, and 22), and limitations on social life (items 8, 12, 14, 18, and 19). Higher scores indicate better quality of life than lower scores. Incontinence Short Test: To determine the level of knowledge about incontinence, Branch et al. The Incontinence Short Test, developed by Kara et al. and whose Turkish version was studied by Kara et al., was used. The 14-item test is answered with "Agree," "Disagree," or "Don't Know." The correct answer for items 1, 4, 6, 8, 10, and 11 is "Agree." For the remaining items, the correct answer is "Disagree." A "Don't Know" response is considered incorrect. The total score ranges from 0 to 14, with a higher score indicating a higher level of knowledge and a more positive attitude toward urinary incontinence. Intervention: The women in the experimental group will receive a 4-week training program on coping with urinary incontinence. The content of this training consists of the following topics: • Definition, types, and risk factors for urinary incontinence
- Treatment and prevention of urinary incontinence
- Non-drug management strategies for managing urinary incontinence symptoms (eating and toilet habits, such as limiting caffeinated beverages and being mindful of spicy foods)
- Importance and implementation of Kegel exercises After the training is completed, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also be given post-tests at 1 and 3 months. Training will be conducted individually via an online platform.
- Data Collection Process: Pre-tests will be administered to the women in the experimental and control groups at the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled pretest-posttest control group experimental research design
| Arm | Type | Receives |
|---|---|---|
| Intervention Group-Training in Coping with Incontinence | Experimental | Behavioral: Incontinence Coping TrainingIntervention: Women in the experimental group will receive a four-week training program on managing urinary incontinence. The training will cover the following topics: * Definition, types, and risk factors of urinary incontinence * Treatment and prevention of urinary incontinence * Symptoms of urinary incontinence and non-drug management strategies (addressing eating and toilet habits, such as limiting caffeinated beverages and cautioning spicy foods) * The importance and implementation of Kegel exercises After the training, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also receive post-tests at 1 and 3 months. Training will be conducted individually online. |
| Control Group | No intervention | –No ıntervention. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Having entered menopause
- Volunteering to participate in the study
- Having no communication barriers
- Using a smartphone
Key exclusion criteria (5 listed)
- Having a communication barrier
- Not having gone through menopause
- Not experiencing urinary incontinence
- Having undergone surgical menopause
- Being obese
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 |
|---|---|---|
| Incontinence Coping TrainingIntervention: Women in the experimental group will receive a four-week training program on managing urinary incontinence. The training will cover the following topics: * Definition, types, and risk factors of urinary incontinence * Treatment and prevention of urinary incontinence * Symptoms of urinary incontinence and non-drug management strategies (addressing eating and toilet habits, such as limiting caffeinated beverages and cautioning spicy foods) * The importance and implementation of Kegel exercises After the training, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also receive post-tests at 1 and 3 months. Training will be conducted individually online. | Behavioural | Intervention Group-Training in Coping with Incontinence |
Primary outcome
Personal Information Form
Time frame: 4 weeks
It consists of a total of 21 questions asking about women's sociodemographic characteristics such as age, education level, income level, birth-related characteristics and urinary incontinence.
The incontinence short test:
Time frame: 16 weeks
A Turkish validity and reliability study was conducted by Kara et al. The test consists of 14 statements and is answered with "Agree," "Disagree," or "Don't Know." The correct answer for statements 1, 4, 6, 8, 10, and 11 is "Agree." The correct answer for the remaining statements is "Disagree." A "Don't Know" response is considered incorrect. The total score ranges from 0 to 14, with higher scores indicating a higher level of knowledge and a more positive attitude toward urinary incontinence.
Pittsburgh Sleep Quality Index:
Time frame: 16 weeks
The scale's validity and reliability studies in Turkey were conducted by Ağargün and colleagues in 1996. The PSQI assesses sleep quality over the past month. The PSQI consists of 24 questions, 19 of which are answered by the individual themselves, and 5 by their spouse or roommate. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score of 5 or higher is considered the cut-off score for poor sleep quality. The scale's Cronbach's alpha reliability coefficient was found to be 0.804.
Urinary Incontinence Quality of Life Scale (I-QOL):
Time frame: 16 weeks
The validity and reliability of the I-QOL was determined by Özerdoğan. All items in the Incontinence Quality of Life Scale are evaluated on a five-category Likert-type scale (1=a great deal, 2=quite a bit, 3=moderately, 4=a little, 5=not at all), and the calculated total score is converted to a scale value from 0 to 100 for better understanding. The Incontinence Quality of Life Scale consists of three subscales: behavioral limitation (items 1, 2, 3, 4, 10, 11, 13, and 20), psychological impact (items 5, 6, 7, 9, 15, 16, 17, 21, and 22), and social limitation (items 8, 12, 14, 18, and 19). High scores indicate better quality of life than low scores.
Personal Information Form
Time frame: 16 weeks
It consists of a total of 21 questions asking about women's sociodemographic characteristics such as age, education level, income level, birth-related characteristics and urinary incontinence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
İlknur AYDIN AVCİ, Prof. Dr. study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incontinence Coping Training in people with Stress Urinary Incontinence, run by Ondokuz Mayıs 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek ÇELİK EREN, Dr. (+905076976158, dilek-celik-61@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: 4 weeks). The study lists 5 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 17 Aug 2025.