NCT07853755

Brief Summary

This study will evaluate whether adding mental rehearsal of pelvic floor muscle contractions to pelvic floor muscle training improves stress urinary incontinence in postmenopausal women. Stress urinary incontinence is urine leakage during activities such as coughing, sneezing, or physical exertion. Mental rehearsal involves imagining the sensation of a movement without physically performing it. The study will include 60 women aged 45 to 65 years who have completed natural menopause and have stress urinary incontinence. Participants will be randomly assigned to one of two groups. Both groups will receive the same supervised pelvic floor muscle training twice a week for 12 weeks. Before performing the pelvic floor exercises, one group will imagine contracting and relaxing the pelvic floor muscles. The other group will imagine making and opening a fist with their dominant hand. Assessments will take place before treatment and at the end of 12 weeks. The main outcome will be urinary incontinence symptom severity. Additional assessments will examine urine leakage frequency and amount, incontinence-related quality of life, and pelvic floor muscle electrical activity.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress6%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

September 25, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

PostmenopauseKinesthetic Motor ImageryPelvic Floor Muscle Training

Outcome Measures

Primary Outcomes (1)

  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score

    Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The questionnaire assesses the frequency and amount of urinary leakage and its impact on everyday life over the previous four weeks. The total score is calculated by summing three scored items and ranges from 0 to 21, with higher scores indicating greater urinary incontinence severity.

    Baseline (before the first treatment session) and at the end of the 12-week intervention.

Secondary Outcomes (4)

  • Mean Daily Stress Urinary Leakage Episodes

    Baseline (before the first treatment session) and at the end of the 12-week intervention.

  • Urinary Loss Measured by the 24-Hour Pad Test

    Baseline (before the first treatment session) and at the end of the 12-week intervention.

  • Incontinence Quality of Life Questionnaire (I-QOL) Total Score

    Baseline (before the first treatment session) and at the end of the 12-week intervention.

  • Mean Pelvic Floor Muscle Electrical Activity During Voluntary Contractions

    Baseline (before the first treatment session) and at the end of the 12-week intervention.

Study Arms (2)

Pelvic Floor Motor Imagery + Pelvic Floor Muscle Training

EXPERIMENTAL

Participants will receive pelvic-floor-specific kinesthetic motor imagery combined with supervised pelvic floor muscle training. Immediately before each physical pelvic floor contraction, participants will imagine the sensation of closing, squeezing, and lifting the pelvic floor muscles, followed by relaxation, without physically contracting during imagery. The program will include 24 supervised sessions over 12 weeks, delivered twice weekly on nonconsecutive days, with each session lasting approximately 30 minutes.

Behavioral: Pelvic Floor Muscle TrainingBehavioral: Pelvic-Floor-Specific Kinesthetic Motor Imagery

Hand Motor Imagery + Pelvic Floor Muscle Training

ACTIVE COMPARATOR

Participants will perform kinesthetic motor imagery of making and opening a fist with the dominant hand, without actual hand movement, immediately before each physical pelvic floor contraction. They will receive the same supervised pelvic floor muscle training as the experimental group. Imagery duration, physical exercise dose, and therapist contact will be matched between groups. The program will include 24 supervised sessions over 12 weeks, delivered twice weekly on nonconsecutive days, with each session lasting approximately 30 minutes.

Behavioral: Pelvic Floor Muscle TrainingBehavioral: Dominant-Hand Kinesthetic Motor Imagery

Interventions

Both groups will receive the same progressive, supervised pelvic floor muscle training program, including slow and fast contractions, graded contractions, and pre-contraction before coughing or physical effort (the Knack). Training will progress across three four-week phases, with increasing contraction demands and progression toward standing and functional activities. The program will be delivered as part of 24 supervised sessions over 12 weeks, twice weekly on nonconsecutive days. Each session, including the assigned motor imagery component, will last approximately 30 minutes. No additional home exercise program will be prescribed.

Hand Motor Imagery + Pelvic Floor Muscle TrainingPelvic Floor Motor Imagery + Pelvic Floor Muscle Training

Participants will mentally rehearse the sensation of closing, squeezing, and lifting the pelvic floor muscles around the urethra and vagina, followed by relaxation, without physically contracting during imagery. Kinesthetic imagery will be performed immediately before each corresponding physical pelvic floor contraction. This component will be integrated into all 24 supervised sessions over 12 weeks. Imagery duration and therapist contact will be matched to the dominant-hand imagery condition.

Pelvic Floor Motor Imagery + Pelvic Floor Muscle Training

Participants will mentally rehearse the sensation of making and opening a fist with their dominant hand, without actual hand movement. This imagery will be performed immediately before each physical pelvic floor contraction and will be integrated into all 24 supervised sessions over 12 weeks. Imagery duration and therapist contact will be matched to the pelvic-floor-specific imagery condition. Participants will receive the same physical pelvic floor muscle training program as the experimental group.

Hand Motor Imagery + Pelvic Floor Muscle Training

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 45 to 60 years.
  • Natural postmenopause, defined as the absence of menstruation for at least 12 consecutive months without a pathological, pharmacological, or surgical cause.
  • Physician-diagnosed stress urinary incontinence.
  • Sufficient cognitive and communication abilities to understand instructions in Turkish and complete the questionnaires and a three-day bladder/leakage diary.
  • A score of at least 30 on each of the visual and kinesthetic imagery subscales of the Kinesthetic and Visual Imagery Questionnaire-20 (KVIQ-20), assessed before randomization.

You may not qualify if:

  • Urgency, mixed, overflow, or neurogenic urinary incontinence.
  • Stage III or IV pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
  • Inability to correctly and voluntarily contract the pelvic floor muscles.
  • Active urinary tract or vaginal infection, unexplained hematuria, or postmenopausal vaginal bleeding.
  • Severe vaginal atrophy, vaginismus, genital lesions, or pelvic pain that prevents intravaginal assessment.
  • Previous surgery for stress urinary incontinence or previous pelvic radiotherapy.
  • Pelvic floor rehabilitation for urinary incontinence within the previous 12 months.
  • Neurological or cognitive disorders, or uncontrolled psychiatric illness, that could affect pelvic floor control, continence, or motor imagery ability.
  • Serious or uncontrolled systemic or musculoskeletal conditions that prevent safe participation in the exercise program.
  • Changes in hormone therapy within the previous six months or changes in medications affecting urinary system function within the previous three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This two-arm, parallel-group randomized controlled trial will allocate 60 participants in a 1:1 ratio (30 per group) to pelvic floor muscle training preceded by either pelvic-floor-specific kinesthetic motor imagery or kinesthetic imagery of making and opening a fist with the dominant hand. Both groups will receive the same supervised pelvic floor muscle training twice weekly for 12 weeks. Assessments will be conducted at baseline and at the end of week 12.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 2, 2026

Study Start

September 28, 2026

Primary Completion (Estimated)

January 5, 2027

Study Completion (Estimated)

January 5, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data. Study findings will be reported in aggregate form

Locations