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Clinical Trials/NCT07324668
NCT07324668
Not yet recruiting
Not Applicable

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

Ondokuz Mayıs University0 sites117 target enrollmentStarted: December 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Ondokuz Mayıs University
Enrollment
117
Primary Endpoint
Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi]

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
45 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control Group

No Intervention

Participants will receive no exercise or educational intervention and will continue their usual daily routines.

Intervention Group 2 (Tai Chi and Kegel, 6 days/week)

Experimental

Participants will perform Tai Chi and Kegel exercises 6 days per week for 8 weeks.

Intervention: Combined Exercise Program (Behavioral)

Intervention Group 1 (Tai Chi and Kegel, 3 days/week)

Experimental

articipants will perform Tai Chi and Kegel exercises 3 days per week for 8 weeks.

Intervention: Combined Exercise Program (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quality of Life Related to Urinary Incontinence(8 weeks (baseline and post-intervention))
  • Self-Efficacy in Managing Urinary Incontinence(Baseline and 8 weeks post-intervention)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Şeyma SOYANIT ERASLAN

Dr.

Ondokuz Mayıs University

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