- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551674
Effects of Action Observation and Metaphorical Imagery in Pelvic Floor Muscle Training for Geriatric Urinary Incontinence
May 8, 2026 updated by: Arzu Razak Ozdinçler, Fenerbahce University
Investigation of the Effects of Pelvic Floor Muscle Training Applied Via Action Observation Method Accompanied by Metaphorical Imagery on Urinary Incontinence in Geriatric Women
This clinical trial investigates the effects of a 12-week Pelvic Floor Muscle Training (PFMT) program applied via Action Observation Therapy (AOT) with metaphorical imagery on urinary incontinence, quality of life, and treatment adherence in geriatric women.
The study will be conducted between June 2025 and June 2026 in nursing homes in Istanbul, targeting women aged 65 and older who are diagnosed with stress or stress-predominant mixed urinary incontinence, possess normal cognitive function (Standardized Mini Mental Test score ≥ 24), and walk independently.
Eligible participants will be divided into groups, where both will undergo a progressive exercise regimen involving twice-weekly 45-50 minute group sessions that advance from supine positions to standing and jumping movements.
However, the AOT study group will uniquely perform these exercises while observing and imagining projected metaphor-themed visuals to enhance motor learning and motivation.
Efficacy will be evaluated pre- and post-intervention using various standardized tools, including the Pelvic Floor Distress Inventory-20, a 24-hour pad test, the Incontinence Severity Index, the Movement Imagery Questionnaire-3, and the Incontinence Quality of Life Scale, to comprehensively assess improvements in incontinence severity, functional status, and overall well-being.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
40
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
- Name: ARZU ÖZDİNÇLER, PROF
- Phone Number: +90 216 910 1907
- Email: arzu.ozdincler@fbu.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34758
- Recruiting
- Fenerbahce University Department of Physiotherapy and Rehabilitation
-
Contact:
- ARZU ÖZDİNÇLER, PROF
- Phone Number: +90 216 910 1907
- Email: arzu.ozdincler@fbu.edu.tr
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed with stress or stress-predominant mixed urinary incontinence by a physician
- Women aged 65 years and older
- Literate in Turkish to understand, interpret, and answer the questionnaires
- Scoring 24 or higher on the Mini-Mental State Examination (MMSE)
- Able to walk independently without the use of any walking aids (assistive devices)
- Having signed the informed consent form
Exclusion Criteria:
- Received pelvic floor muscle training within the past 6 months
- Presence of fecal incontinence
- Current genitourinary infection or use of medication for urinary incontinence
- History of urinary incontinence surgery or presence of symptomatic pelvic organ prolapse
- Presence of neurological, orthopedic, psychiatric, hematological, or cardiovascular conditions that would preclude participation in exercise
- Body mass index (BMI) ≥ 25 kg/m²
- Hearing or visual impairments that would negatively affect participation
- Presence of hematuria, urethral and/or bladder fistula, or a history of pelvic surgery
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pelvic Floor Muscle Training program
Exercise
|
Participants will engage in a 12-week Pelvic Floor Muscle Training (PFMT) program.
The exercises will be conducted twice a week in group sessions lasting 45-50 minutes each.
These sessions will be supervised by a physiotherapist and performed in small groups of five participants.
|
|
Experimental: Pelvic Floor Muscle Training via Action Observation Therapy
Exercise with AOT
|
Participants will be enrolled in a Pelvic Floor Muscle Training (PFMT) program using the action observation method accompanied by metaphorical imagery.
This program will be administered over 12 weeks, consisting of twice-weekly group sessions lasting 45-50 minutes each.
The exercise content is identical for both groups.
However, during the sessions for this specific group, metaphor-themed visuals will be projected onto a screen, and participants will be given the instruction: 'Perform the movement by imagining it as shown in the visual.'
To enhance physical participation and motivation, verbal cues and positive reinforcement will be provided by the physiotherapist.
The exercises and the corresponding metaphors will be updated on a weekly basis.
All sessions will be supervised by a physiotherapist in small groups of five participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mini-Mental State Examination
Time Frame: Baseline and after 12-weeks
|
Baseline and after 12-weeks
|
|
Pelvic Floor Distress Inventory
Time Frame: Baseline and after 12-weeks
|
Baseline and after 12-weeks
|
|
The Incontinence Severity Index
Time Frame: Baseline and after 12-weeks
|
Baseline and after 12-weeks
|
|
Movement Imagery Questionnaire-3
Time Frame: Baseline and after 12-weeks
|
Baseline and after 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Geriatric Self-Efficacy Index for Urinary Incontinence
Time Frame: Baseline and after 12-weeks
|
Baseline and after 12-weeks
|
|
Incontinence Quality of Life Questionnaire
Time Frame: Baseline and after 12-weeks
|
Baseline and after 12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
March 19, 2025
Primary Completion (Estimated)
July 27, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
April 20, 2026
First Submitted That Met QC Criteria
April 20, 2026
First Posted (Actual)
April 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
Other Study ID Numbers
- 1002-GERIATRICS-UI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be shared upon reasonable request to the principal investigator/corresponding author for the purpose of meta-analysis or related academic research.
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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