Urinary Incontinence, StressHER-PhysioNCT03296462
Hip External Rotation Physical Therapy Trial
A study testing Hip external rotation exercise and Pelvic floor muscle exercise in people with Urinary Incontinence, Stress, run by University of Alberta at 1 site in Canada.
Trial summary
This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Hip external rotation exercise and Pelvic floor muscle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2016to 10 Jul 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence
- Attending Lois Hole Hospital for Women Urogynecology Clinic
- Referred for physiotherapy for stress urinary incontinence
- Able to toilet independently
- Able to undertake hip rotation exercises
- Able to speak and read English
Who cannot join
- Urge urinary incontinence
- Using a pessary
- Neurological or cognitive impairment
- Using other treatment for incontinence
- Unable to complete study forms
- Unable to understand educational instruction
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lois Hole Hospital for Women, Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
About this study
Official title: Physiotherapy for Stress Urinary Incontinence: Feasibility Study for a Randomized Controlled Trial of Hip External Rotation Exercise Training Versus Pelvic Floor Muscle Exercise Training
This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.
The study interventions used in the feasibility study will be training of (1) Hip Extension Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
Read the detailed description
Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy practice for the treatment of stress urinary incontinence (SUI) despite little evidence compared to the proven effective standard of care treatment, pelvic floor muscle (PFM) exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise alone or in combination with PFM is more or less effective than PFM exercises alone.
Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.
Interventions: The interventions used in the feasibility study will be training of (1) HER exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention.
Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training, appropriateness of outcome measures and completion rates. The design of the proposed RCT will be based on these feasibility outcomes.
Outcome measures for the proposed RCT will include pelvic floor muscle strength, external hip rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of life, and (to test patient mobility) six minute walk test and timed up and go test.
Sample size: The proposed sample size is 30 participants. Duration of study: After recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at the end of that period, and a further follow up at 24 weeks from recruitment.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Hip external rotation exercise, Pelvic floor muscle exercise
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip external rotation exerciseOther
Standardised HER exercise training by physiotherapist (plus video recording of exercises)
Pelvic floor muscle exerciseOther
Standardised PFM exercise training by physiotherapist (plus video recording of exercises)
| Study group | Role | What they receive |
|---|---|---|
| Hip external rotation exercise (alone) | Experimental | Standardised hip external rotation exercise training - over 12 week period Receives: Other: Hip external rotation exercise |
| Hip external rotation + PFM exercises | Experimental | Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period Receives: Other: Hip external rotation exercise; Other: Pelvic floor muscle exercise |
| pelvic floor muscle exercises (alone) | Active comparator | Standardised pelvic floor muscle exercises - over 12 week period (usual care) Receives: Other: Pelvic floor muscle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: achieve recruitment of 30 women over 12 months
Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months
Measured: 12 months
Feasibility: achieve follow-up for 60% of recruits over 12 months
Is follow-up complete for 60% of recruits?
Measured: 12 months
Secondary outcomes (7)
Pelvic floor muscle strength
Strength will be measured using Peritron perineometer
Measured: 12 & 24 weeks
External hip rotator muscle strength
Strength will be measured using Microfit ET3
Measured: 12 & 24 weeks
Diary-reported urinary incontinence
3-day bladder diary to record amount and reason for leakage
Measured: 12 & 24 weeks
Incontinence-related quality of life (distress)
UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum)
Measured: 12 & 24 weeks
Incontinence-related quality of life (impact)
IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum)
Measured: 12 & 24 weeks
Patient mobility (walking)
Six minute walk test - distance walked (metres)
Measured: 12 & 24 weeks
Patient mobility
"timed up and go" test - time in sconds
Measured: 12 & 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start3 Nov 2016
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Physiotherapy Alberta - College + Association
- Responsible party
- Sponsor
- Investigators
- Sue Ross, PhD, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296462
- Sponsor's protocol ID
- Pro00066652
- Acronym
- HER-Physio
- Status last verified
- May 2022
- First submitted
- 18 Sep 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy for Stress Urinary Incontinence: Feasibility Study for a Randomized Controlled Trial of Hip External Rotation Exercise Training Versus Pelvic Floor Muscle Exercise Training
- ClinicalTrials.gov ID
- NCT03296462
- Acronym / sponsor ID
- HER-Physio / Pro00066652
- Conditions
- Urinary Incontinence, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Physiotherapy Alberta - College + Association
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 28 Sep 2017 (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 RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.
The study interventions used in the feasibility study will be training of (1) Hip Extension Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
Detailed description
Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy practice for the treatment of stress urinary incontinence (SUI) despite little evidence compared to the proven effective standard of care treatment, pelvic floor muscle (PFM) exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise alone or in combination with PFM is more or less effective than PFM exercises alone.
Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.
Interventions: The interventions used in the feasibility study will be training of (1) HER exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention.
Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training, appropriateness of outcome measures and completion rates. The design of the proposed RCT will be based on these feasibility outcomes.
Outcome measures for the proposed RCT will include pelvic floor muscle strength, external hip rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of life, and (to test patient mobility) six minute walk test and timed up and go test.
Sample size: The proposed sample size is 30 participants. Duration of study: After recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at the end of that period, and a further follow up at 24 weeks from recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hip external rotation exercise (alone) | Experimental | Other: Hip external rotation exerciseStandardised hip external rotation exercise training - over 12 week period |
| Hip external rotation + PFM exercises | Experimental | Other: Hip external rotation exercise, Other: Pelvic floor muscle exerciseStandardised hip external rotation plus pelvic floor muscle exercises - over 12 week period |
| pelvic floor muscle exercises (alone) | Active comparator | Other: Pelvic floor muscle exerciseStandardised pelvic floor muscle exercises - over 12 week period (usual care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stress urinary incontinence
- Attending Lois Hole Hospital for Women Urogynecology Clinic
- Referred for physiotherapy for stress urinary incontinence
- Able to toilet independently
- Able to undertake hip rotation exercises
Key exclusion criteria (6 listed)
- Urge urinary incontinence
- Using a pessary
- Neurological or cognitive impairment
- Using other treatment for incontinence
- Unable to complete study forms
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 external rotation exerciseStandardised HER exercise training by physiotherapist (plus video recording of exercises) | Other | Hip external rotation + PFM exercises, Hip external rotation exercise (alone) |
| Pelvic floor muscle exerciseStandardised PFM exercise training by physiotherapist (plus video recording of exercises) | Other | Hip external rotation + PFM exercises, pelvic floor muscle exercises (alone) |
Primary outcome
Feasibility: achieve recruitment of 30 women over 12 months
Time frame: 12 months
Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months
Feasibility: achieve follow-up for 60% of recruits over 12 months
Time frame: 12 months
Is follow-up complete for 60% of recruits?
7 secondary outcomes
Pelvic floor muscle strength
Time frame: 12 & 24 weeks
External hip rotator muscle strength
Time frame: 12 & 24 weeks
Diary-reported urinary incontinence
Time frame: 12 & 24 weeks
Incontinence-related quality of life (distress)
Time frame: 12 & 24 weeks
Incontinence-related quality of life (impact)
Time frame: 12 & 24 weeks
Patient mobility (walking)
Time frame: 12 & 24 weeks
Patient mobility
Time frame: 12 & 24 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 26 May 2022.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Sue Ross, PhD study director
University of Alberta
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 external rotation exercise and Pelvic floor muscle exercise in people with Urinary Incontinence, Stress, run by University of Alberta at 1 site in Canada.
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 6 inclusion and 6 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 26 May 2022. 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 Canada. 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?
Feasibility: achieve recruitment of 30 women over 12 months (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT03296462, which also lists 1 linked publication.
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 26 May 2022.