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

Urinary Incontinence Clinical Trial

— WIN  

Official title:

The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function as a Potential Non-surgical Management for Urinary Incontinence in Older Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04631926
• Other study ID #: Women & Urinary INcontinence
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: Isuzu Meyer, MD. MSPH
• Phone: (205) 996-9580
• Email: imeyer[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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)

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)

Related Conditions & MeSH terms

• Enuresis
• Geriatric Syndrome
• Urinary Incontinence

Intervention

Behavioral:
• Hip Muscle Exercise
Standardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance

Locations

Country	Name	City	State
United States	The Kirklin Clinic of Uab Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor muscle strength	pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises	Baseline
Primary	Pelvic floor muscle strength	pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises	12 weeks
Secondary	Urinary incontinence symptom severity	urinary incontinence specific symptom severity - Validated questionnaire score Pelvic Floor Disability Index (PFDI), pre 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	Baseline
Secondary	Urinary incontinence symptom severity	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	12 weeks
Secondary	Impact of urinary incontinence symptoms on quality of life	impact of urinary incontinence symptoms on quality of life - validated questionnaire score Pelvic Floor Impact Questionnaire (PFIQ), pre 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:	Baseline
Secondary	Impact of urinary incontinence symptoms on quality of life	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:	12 weeks