The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence

Not Applicable

Completed

• Conditions: Geriatric Syndrome; Urinary Incontinence
• Interventions: Behavioral: Hip Muscle Exercise

• Registration Number: NCT04631926
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (UI) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training).

Detailed Description

This is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (UI) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training). Participants will take part in a 12-week hip muscle exercise program (weekly supervised hip exercises with resistance progression) plus a home program with the same exercises 3 days per week. the exercise program will be administered by the licensed physical therapist with special focus in hip strength. The change in pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre- to post hip muscle exercises. Changes in UI symptom severity, and impact of UI symptoms on quality of life will be assessed. Objective measurement of pelvic floor muscle strength will be obtained using a perineometer. UI symptom severity and quality of life will be measured using validated questionnaires (PFDI and PFIQ, respectively).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-17
• Study Start: 2022-02-21
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Women ages ≥65
• UI for at least the last 3 months UI will be defined using the following (a widely-accepted definition in epidemiologic studies) Scores 3 - 12 on the validated 2-item Incontinence Severity Index (ISI)

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Exclusion Criteria

• Women unable to follow-up, not willing to, or unable to participate in the exercise intervention program
• Prior or current treatment for UI including previous FDA approved medications for UI, prior surgery for UI within the past 12 months
• Pelvic organ prolapse beyond the hymen
• Potential causes or conditions associated with neurogenic bladder (multiple sclerosis, Parkinson's disease, stroke, spinal cord injury)
• Urinary retention, incomplete bladder emptying (via bladder scan, >150mL post-void residual)
• Conditions (neurological or musculoskeletal) that compromise mobility, requiring assisted device for ambulation or wheel chair
• Diagnosis of dementia or cognitive impairment (Montreal Cognitive Assessment [MoCA] <25, mild cognitive impairment)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hip Muscle Exercises	Hip Muscle Exercise	Hip Muscle Exercises

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength	12 weeks	pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises

Secondary Outcome Measures

Name	Time	Method
Impact of urinary incontinence symptoms on quality of life	12 weeks	impact of urinary incontinence symptoms on quality of life - validated questionnaire score (PFIQ), post muscle exercises. It is a health-related quality of life questionnaire for women with pelvic floor conditions. PFIQ has 7 questions and each question has 3 separate responses (one for each of 3 scales). All of the items use the following response scale: 0 = Not at all; 1 = Somewhat; 2 = Moderately; 3 = Quite a bit Scales:
Urinary incontinence symptom severity	12 weeks	urinary incontinence specific symptom severity - Pelvic Floor Disability Index (PFDI), post hip muscle exercises. PFDI Questionnaire is for certain bowel, bladder, or pelvic symptoms and, see, how much they bother. The PFDI-20 has 20 items and 3 scales of your symptoms. All items use the following format with a response scale from 0 not present to 4 worst. Symptom scale: 0 = not present 1= not at all 2 = somewhat 3 = moderately 4 = quite a bit

Trial Locations

Locations (1)

The Kirklin Clinic of Uab Hospital; 🇺🇸 Birmingham, Alabama, United States