The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence (WIN)
Primary Purpose
Urinary Incontinence, Geriatric Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Muscle Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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)
Sites / Locations
- The Kirklin Clinic of Uab HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hip Muscle Exercises
Arm Description
Hip Muscle Exercises
Outcomes
Primary Outcome Measures
Pelvic floor muscle strength
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises
Pelvic floor muscle strength
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises
Secondary Outcome Measures
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
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
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:
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:
Full Information
NCT ID
NCT04631926
First Posted
November 6, 2020
Last Updated
February 14, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04631926
Brief Title
The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Geriatric Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hip Muscle Exercises
Arm Type
Other
Arm Description
Hip Muscle Exercises
Intervention Type
Behavioral
Intervention Name(s)
Hip Muscle Exercise
Intervention Description
Standardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength
Description
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises
Time Frame
Baseline
Title
Pelvic floor muscle strength
Description
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Urinary incontinence symptom severity
Description
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
Time Frame
Baseline
Title
Urinary incontinence symptom severity
Description
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
Time Frame
12 weeks
Title
Impact of urinary incontinence symptoms on quality of life
Description
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:
Time Frame
Baseline
Title
Impact of urinary incontinence symptoms on quality of life
Description
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:
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
65 and older
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isuzu Meyer, MD. MSPH
Phone
(205) 996-9580
Email
imeyer@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sunita Patel
Phone
205-996-0241
Email
suitapatel@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isuzu Meyer, MD. MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Kirklin Clinic of Uab Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35223
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence
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