Effect of Coping Training on Attitudes, Sleep, and Quality of Life in Women With Stress Urinary Incontinence

NCT ID: NCT07126080

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-06-15

Brief 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.

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

1. Research Model: This study will be conducted using a randomized controlled pretest-posttest control group experimental research design.

2. 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.

3. 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.

4. Data Collection Process: Pre-tests will be administered to the women in the experimental and control groups at the clinic.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group-Training in Coping with Incontinence

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.

Group Type: EXPERIMENTAL

Incontinence Coping Training

Intervention Type: BEHAVIORAL

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.

Control Group

No ıntervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Incontinence Coping Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Having a communication barrier
• Not having gone through menopause
• Not experiencing urinary incontinence
• Having undergone surgical menopause
• Being obese

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Dilek Celi̇k Eren

Ass. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlknur AYDIN AVCİ, Prof. Dr.

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Ondokuz Mayıs University

Samsun, Samsun, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Dilek ÇELİK EREN, Dr.

Role: CONTACT

dilek-celik-61@hotmail.com

+905076976158

Özge ÖZ YILDIRIM, Dr.

Role: CONTACT

ozge.oz@omu.edu.tr

+905054914471

Facility Contacts

Dilek ÇELİK EREN

Role: primary

dilek-celik-61@hotmail.com

05076976158

Other Identifiers

There is no funding.

Identifier Type: OTHER

Identifier Source: secondary_id

2025-845

Identifier Type: -

Identifier Source: org_study_id