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

NCT04631926 | Completed

• 1 other identifier: Women & Urinary INcontinence
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Incontinence; Geriatric Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Urinary incontinence symptom severity

  Baseline

• Urinary incontinence symptom severity

  12 weeks

• Impact of urinary incontinence symptoms on quality of life

  Baseline

• Impact of urinary incontinence symptoms on quality of life

  12 weeks

Study Arms (1)

Hip Muscle Exercises

OTHER

Hip Muscle Exercises

Behavioral: Hip Muscle Exercise

Interventions

Hip Muscle Exercise BEHAVIORAL

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

Hip Muscle Exercises

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: 65 and older
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The Kirklin Clinic of Uab Hospital

Birmingham, Alabama, 35223, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Isuzu Meyer, MD. MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 17, 2020
• Study Start: February 21, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 30, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)