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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34758
        • Recruiting
        • Fenerbahce University Department of Physiotherapy and Rehabilitation
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pelvic Floor Muscle Training program
Exercise
Other: Pelvic Floor Muscle Training program
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
Other: Pelvic Floor Muscle Training via Action Observation Therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fenerbahce 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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