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NCT Number: NCT04631926

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

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).

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Geriatric Syndrome Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Kirklin Clinic of Uab Hospital

Birmingham, Alabama, 35223, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hip Muscle Exercise

Behavioral

Standardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance

Primary outcomes

  1. Pelvic floor muscle strength

    Time frame: Baseline

    pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises

  2. Pelvic floor muscle strength

    Time frame: 12 weeks

    pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises

Secondary outcomes

  1. Urinary incontinence symptom severity

    Time frame: Baseline

    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

  2. Urinary incontinence symptom severity

    Time frame: 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

  3. Impact of urinary incontinence symptoms on quality of life

    Time frame: Baseline

    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:

  4. Impact of urinary incontinence symptoms on quality of life

    Time frame: 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:

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study 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

Acronym: WIN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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