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

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

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).

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Geriatric Syndrome
• Intervention / Treatment: Behavioral: Hip Muscle Exercise

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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35223
      • The Kirklin Clinic of UAB Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hip Muscle Exercises	Behavioral: Hip Muscle Exercise; Standardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor muscle strength	pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises	Baseline
Pelvic floor muscle strength	pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Isuzu Meyer, MD. MSPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: Women & Urinary INcontinence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No