NCT07126080

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 29, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

PostmenopausalStress Urinary Incontinencecoping strategieshealth qualityAttitudeSleep Quality

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    16 weeks

Study Arms (2)

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.

Behavioral: Incontinence Coping Training

Control Group

NO INTERVENTION

No ıntervention.

Interventions

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 Group-Training in Coping with Incontinence

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, StressBehaviorSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • İlknur AYDIN AVCİ, Prof. Dr.

    Ondokuz Mayıs University

    STUDY DIRECTOR

Central Study Contacts

Dilek ÇELİK EREN, Dr.

CONTACT

Özge ÖZ YILDIRIM, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled pretest-posttest control group experimental research design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 17, 2025

Study Start

August 15, 2025

Primary Completion

December 15, 2025

Study Completion

June 15, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Locations