NCT07324668

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 15, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 23, 2025

Last Update Submit

December 23, 2025

Conditions

Keywords

PostmenopauseWomen's healthMultimodal interventionUrinary incontinenceQuality of lifeEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi]

    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 Outcomes (2)

  • 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

Study Arms (3)

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.

Behavioral: Combined Exercise Program

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.

Behavioral: Combined Exercise Program

Control Group

NO INTERVENTION

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

Interventions

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

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

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups: 1. Experimental Group 1 will perform Tai Chi and Kegel exercises 3 days per week, 2. Experimental Group 2 will perform Tai Chi and Kegel exercises 6 days per week, and 3. the Control Group will receive no intervention. All groups will be evaluated at baseline and after 8 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 7, 2026

Study Start

December 15, 2025

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

January 7, 2026

Record last verified: 2025-12