Clinical trial NCT04631926: The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence
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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Geriatric Syndrome
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 32
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Pelvic floor muscle strength
timeFrame: Baseline
measure: Pelvic floor muscle strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Urinary incontinence symptom severity
timeFrame: Baseline
measure: Urinary incontinence symptom severity
timeFrame: 12 weeks
measure: Impact of urinary incontinence symptoms on quality of life
timeFrame: Baseline
measure: Impact of urinary incontinence symptoms on quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic of Uab Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Isuzu Meyer, MD. MSPH
role: PRINCIPAL_INVESTIGATOR
References: