Effects of Multiple Intervention on Postmenopausal Women With UI (UI Program)

December 23, 2025 updated by: Şeyma SOYANIT ERASLAN, Ondokuz Mayıs University

The Effects of a Multiple Intervention Approach Applied to Postmenopausal Women on Quality of Life, Self-efficacy, and Urinary Incontinence Severity: a Temporal Analysis

Study

The purpose of this clinical trial was to investigate the effects of a multi-intervention approach, including Kegel and Tai Chi exercises, on quality of life, self-efficacy, and urinary incontinence severity in postmenopausal women.

Key Questions the Study Aims to Answer:

How does the multi-intervention approach affect quality of life?

Does the multi-intervention approach affect women's self-efficacy?

How does the multi-intervention approach affect urinary incontinence severity?

How does the frequency of exercises (3 days per week vs. 6 days per week) affect these outcomes?

Do the effects of the intervention change temporally over the 8-week period?

Who is Eligible?

Women aged 45 and over who have gone through menopause

Those who wish to volunteer for the study

Those who have no communication barriers

Those who have not previously received treatment for urinary incontinence

Those who can use a smartphone or WhatsApp

Those who experience urine leakage when coughing or sneezing

Study Application:

The exercises will be administered for 8 weeks.

Participants will be taught how to perform the exercises and will be demonstrated through brochures and videos.

Reminders will be provided during the exercises.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Being female

Having undergone menopause

Willingness to participate in the study

No communication barriers

Not receiving any treatment for urinary incontinence

Owning a smartphone

Having WhatsApp installed

Experiencing urinary leakage when coughing or sneezing, according to the International Continence Society (ICS) definition

Exclusion Criteria:

Having communication barriers

Not being in menopause

Not owning a smartphone

Not experiencing urinary incontinence

Having received any treatment for urinary incontinence

Having undergone surgical menopause

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group 1 (Tai Chi and Kegel, 3 days/week)
articipants will perform Tai Chi and Kegel exercises 3 days per week for 8 weeks.
Behavioral: Combined Exercise Program
Participants will receive education on urinary incontinence, Kegel and Tai Chi exercises, brochures and videos, and perform exercises 3 days/week for 8 weeks with reminders
Behavioral: Combined Exercise Program
Participants will receive same education and materials as Group 1 and perform exercises 6 days/week for 8 weeks with reminders.
Experimental: Intervention Group 2 (Tai Chi and Kegel, 6 days/week)
Participants will perform Tai Chi and Kegel exercises 6 days per week for 8 weeks.
Behavioral: Combined Exercise Program
Participants will receive education on urinary incontinence, Kegel and Tai Chi exercises, brochures and videos, and perform exercises 3 days/week for 8 weeks with reminders
Behavioral: Combined Exercise Program
Participants will receive same education and materials as Group 1 and perform exercises 6 days/week for 8 weeks with reminders.
No Intervention: Control Group
Participants will receive no exercise or educational intervention and will continue their usual daily routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi]
Time Frame: 8 weeks (baseline and post-intervention)
Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.
8 weeks (baseline and post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Related to Urinary Incontinence
Time Frame: 8 weeks (baseline and post-intervention)
Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.
8 weeks (baseline and post-intervention)
Self-Efficacy in Managing Urinary Incontinence
Time Frame: Baseline and 8 weeks post-intervention
Participants' self-efficacy will be measured using a validated scale, comparing baseline and post-test scores.
Baseline and 8 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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