NCT07551674

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
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 Progress78%
Mar 2025Sep 2026

Study Start

First participant enrolled

March 19, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

urinary incontinencegeriatricsaction observation

Outcome Measures

Primary Outcomes (4)

  • Mini-Mental State Examination

    Baseline and after 12-weeks

  • Pelvic Floor Distress Inventory

    Baseline and after 12-weeks

  • The Incontinence Severity Index

    Baseline and after 12-weeks

  • Movement Imagery Questionnaire-3

    Baseline and after 12-weeks

Secondary Outcomes (2)

  • Geriatric Self-Efficacy Index for Urinary Incontinence

    Baseline and after 12-weeks

  • Incontinence Quality of Life Questionnaire

    Baseline and after 12-weeks

Study Arms (2)

Pelvic Floor Muscle Training program

EXPERIMENTAL

Exercise

Other: Pelvic Floor Muscle Training program

Pelvic Floor Muscle Training via Action Observation Therapy

EXPERIMENTAL

Exercise with AOT

Other: Pelvic Floor Muscle Training via Action Observation Therapy

Interventions

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.

Pelvic Floor Muscle Training program

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.

Pelvic Floor Muscle Training via Action Observation Therapy

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahce University Department of Physiotherapy and Rehabilitation

Istanbul, 34758, Turkey (Türkiye)

RECRUITING

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

ARZU ÖZDİNÇLER, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROF DR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

March 19, 2025

Primary Completion

April 27, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Data will be shared upon reasonable request to the principal investigator/corresponding author for the purpose of meta-analysis or related academic research.

Locations