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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04631926
Other study ID # Women & Urinary INcontinence
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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