Urinary IncontinenceWINNCT04631926
The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence
A study testing Hip Muscle Exercise in people with Urinary Incontinence and Geriatric Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Geriatric Syndrome
- What is being tested?
- Hip Muscle Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Kirklin Clinic of Uab Hospital
Birmingham, Alabama, 35223
About this study
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
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).
Read the 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).
- Conditions
- Urinary Incontinence, Geriatric Syndrome
- Being tested
- Hip Muscle Exercise
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Muscle ExerciseBehavioural
Standardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance
| Study group | Role | What they receive |
|---|---|---|
| Hip Muscle Exercises | Other | Hip Muscle Exercises Receives: Behavioral: Hip Muscle Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises
Measured: Baseline
Pelvic floor muscle strength
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises
Measured: 12 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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:
Measured: 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:
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start21 Feb 2022
- Primary completion15 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isuzu Meyer, University of Alabama at Birmingham
- Investigators
- Isuzu Meyer, MD. MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631926
- Sponsor's protocol ID
- Women & Urinary INcontinence
- Acronym
- WIN
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04631926
- Acronym / sponsor ID
- WIN / Women & Urinary INcontinence
- Conditions
- Urinary Incontinence, Geriatric Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip Muscle Exercises | Other | Behavioral: Hip Muscle ExerciseHip Muscle Exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip Muscle ExerciseStandardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance | Behavioural | Hip Muscle Exercises |
Primary outcome
Pelvic floor muscle strength
Time frame: Baseline
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre hip muscle exercises
Pelvic floor muscle strength
Time frame: 12 weeks
pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) post hip muscle exercises
4 secondary outcomes
Urinary incontinence symptom severity
Time frame: Baseline
Urinary incontinence symptom severity
Time frame: 12 weeks
Impact of urinary incontinence symptoms on quality of life
Time frame: Baseline
Impact of urinary incontinence symptoms on quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isuzu Meyer, MD. MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Muscle Exercise in people with Urinary Incontinence and Geriatric Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.