Women With Stress Urinary IncontinencePROTOGLUTNCT05635175
Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence
A study testing hip abductors physiotherapy self training, Standard pelvic floor muscle training and Standard pelvic floor muscle training self training in people with Women With Stress Urinary Incontinence, run by University Hospital, Rouen at 3 sites in France.
Trial summary
Urinary incontinence (UI) is estimated to affect 25% à 45 % women all over the world. UI is associated with a poor Quality of life, with a strong level of certainty. Stress urinary incontinence (SUI) is the second more prevalent type of UI . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Women With Stress Urinary Incontinence
- What is being tested?
- hip abductors physiotherapy self training, Standard pelvic floor muscle training and Standard pelvic floor muscle training self training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Sep 2023to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women ≥ 18 ans
- patient with urinary incontinence according to the ICS criteria [3]
- having received a prescription for perineal rehabilitation
- affiliated to french health care insurance
- Patient having read and understood the information letter and signed the consent form
- Effective contraception in women of childbearing age (negative urine pregnancy test). For postmenopausal women, a confirmatory diagnosis must be obtained (amenorrhea for at least 12 months before the inclusion visit)
Who cannot join
- Bladder pathologies (cyst, tumour, interstitial cystitis)
- Neurological pathologies (multiple sclerosis, Parkinson's desease, etc.)
- Pregnant or parturient or breastfeeding woman or absence of proven contraception
- Person deprived of liberty by administrative or judicial decision or a person placed under the safeguard of justice, or guardianship or curatorship
- Physical inability to perform hip abductors exercises (unable to walk or stand independently)
- Women having scheduled continence surgery before the end of physiotherapy sessions at the time of randomization
- Women having at least one of the continence-specific anticholinergic treatments prescribed before the end of the physiotherapy sessions at the time of randomization
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Pôle santé de la Grace Dieu
Caen
Guillaume GALLIOU, physiotherapist, + 33 2 31 83 48 02, guillaume.galliou@gmail.com
- Recruiting
Chu Rouen
Rouen
Benoit STEENSTRUP, physiotherapist, + 33 2 32 88 81 55, benoit.steenstrup@chu-rouen.fr
- Recruiting
Médipôle du Rouvray
Saint-Étienne-du-Rouvray
Claire BRETON, physiotherapist, + 33 2 35 66 06 38, clairebreton.kine@gmail.com
About this study
Urinary incontinence (UI) is estimated to affect 25% à 45 % women all over the world. UI is associated with a poor Quality of life, with a strong level of certainty. Stress urinary incontinence (SUI) is the second more prevalent type of UI . First-line treatment for SUI is conservative, non-drug and non-surgical treatment. Among these techniques, physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) as a first-line treatment; however, only half of women with SUI are cured with PFMT.
Brain imaging shows that PFMs (involved in continence mechanisms) and gluteal muscles can activate the same cortical region. This synergy is found if the gluteal muscles are voluntarily activated, but not if the PFMs are volontary activated alone . In women, hip abductor physiotherapy is a common practice which has already been the subject of a very extensive literature and has largely shown its effectiveness in the quality of lumbo-pelvic control, balance, quality of life and risk of fall prevention. This rehabilitation is based on exercises that induce solicitation of the hip abductors by synergistic reflex activation during a range of well-known exercises. Recent work has shown the effect of hip abductors on the activation of the PFMs . Until today, there is no literature evaluating the effectiveness of a hip abductors training program without associated voluntary contraction of the PFMs (PPM) on UI. The hypothesis of this work will be to demonstrate that a complementary training focused on the hip abductor, complementary to concomitant PFMT, would benefit from a more significant improvement in continence, and also in physical abilities and quality of life. Because balance seems involved in UI, we therefore propose to to observe the effects on the frontal balance of the pelvis. As the investigators have already done in previous studies, to identifying factors that predict the success of our interventions, investiagtors have planned to evaluate the observance and adherence of our patients .Complementary, the investigators planned to evaluate the effect of both intervention on pelvic floor muscles and hip abductors strength and endurance, pelvic organ prolapse symptoms and quality of life. For this objective, the investigators intend to compare two randomized parallel groups: Group A follow a 12 sessions supervised PFMT + home based PFMs exercices. Group B follow a 12 sessions supervised PFMT + home based hip abductor exercices.
- Conditions
- Women With Stress Urinary Incontinence
- Being tested
- hip abductors physiotherapy self training, Standard pelvic floor muscle training, Standard pelvic floor muscle training self training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip abductors physiotherapy self trainingOther
hip abductors self training program during 7 to 10 weeks associate with a PFMT
Standard pelvic floor muscle trainingOther
Standard pelvic floor muscle training
Standard pelvic floor muscle training self trainingOther
Standard pelvic floor muscle training self training
| Study group | Role | What they receive |
|---|---|---|
| physiotherapist-supervised pelvic floor muscle training | Active comparator | physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training PFMT Receives: Other: Standard pelvic floor muscle training; Other: Standard pelvic floor muscle training self training |
| hip abductors self training program | Experimental | physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training hip abductors self training program Receives: Other: hip abductors physiotherapy self training; Other: Standard pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the number of leaks per week observed after the end of treatment between the two arms at the last physiotherapy session.
This number of leaks per week will be recorded using question 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF).
Measured: 10 weeks
Secondary outcomes (14)
Measurement in centimeters of the offset in the frontal plane of the postero-superior iliac spines during a one leg stance
Measured: 10 weeks
Average of the measurement in Newton of the force of the hip abductors during a maximum manual resistance test repeated 3 times using a dynamometer
Measured: 10 weeks
Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times
Measured: 10 weeks
Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing
Measured: 10 weeks
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire
min: 0 : better outcome max : 21 worse outcome
Measured: 10 weeks
Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire
Measured: 10 weeks
Short Form-36 Quality of Life overall score and subscores
Measured: 10 weeks
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Measured: 10 weeks
Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment)
Measured: 10 weeks
Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment)
Measured: 10 weeks
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire questionnaire
Measured: through study completion, an average of 6 month
Overall score and sub-scores of urinary symptoms of the Prolapsus Quality of Life questionnaire 3. SF-36 Quality of Life overall score and subscores
Measured: throught study completion, an average of 6 month
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Measured: throught study completion, an average of 6 month
Score du questionnaire Patient Global Impression of Improvement (PGI-I)
min: 1 better outcome max : 7 worse outcome
Measured: throught study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start28 Sep 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Women With Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635175
- Sponsor's protocol ID
- 2020/0176/HP
- Other IDs
- 2020-A02148-31
- Acronym
- PROTOGLUT
- Status last verified
- Sep 2025
- First submitted
- 3 Nov 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart WF, Hirsh AG, Kirchner HL, Clarke DN, Litchtenfeld MJ, Minassian VA. Urinary incontinence incidence: quantitative meta-analysis of factors that explain variation. J Urol. 2014 Apr;191(4):996-1002. doi: 10.1016/j.juro.2013.10.050. Epub 2013 Oct 16.
PubMed 24140547Ebbesen MH, Hunskaar S, Rortveit G, Hannestad YS. Prevalence, incidence and remission of urinary incontinence in women: longitudinal data from the Norwegian HUNT study (EPINCONT). BMC Urol. 2013 May 30;13:27. doi: 10.1186/1471-2490-13-27.
PubMed 23721491Pizzol D, Demurtas J, Celotto S, Maggi S, Smith L, Angiolelli G, Trott M, Yang L, Veronese N. Urinary incontinence and quality of life: a systematic review and meta-analysis. Aging Clin Exp Res. 2021 Jan;33(1):25-35. doi: 10.1007/s40520-020-01712-y. Epub 2020 Sep 22.
PubMed 32964401Hay-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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05635175
- Acronym / sponsor ID
- PROTOGLUT / 2020/0176/HP
- Conditions
- Women With Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 2 Dec 2022 (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.
Urinary incontinence (UI) is estimated to affect 25% à 45 % women all over the world. UI is associated with a poor Quality of life, with a strong level of certainty. Stress urinary incontinence (SUI) is the second more prevalent type of UI . First-line treatment for SUI is conservative, non-drug and non-surgical treatment. Among these techniques, physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) as a first-line treatment; however, only half of women with SUI are cured with PFMT.
Brain imaging shows that PFMs (involved in continence mechanisms) and gluteal muscles can activate the same cortical region. This synergy is found if the gluteal muscles are voluntarily activated, but not if the PFMs are volontary activated alone . In women, hip abductor physiotherapy is a common practice which has already been the subject of a very extensive literature and has largely shown its effectiveness in the quality of lumbo-pelvic control, balance, quality of life and risk of fall prevention. This rehabilitation is based on exercises that induce solicitation of the hip abductors by synergistic reflex activation during a range of well-known exercises. Recent work has shown the effect of hip abductors on the activation of the PFMs . Until today, there is no literature evaluating the effectiveness of a hip abductors training program without associated voluntary contraction of the PFMs (PPM) on UI. The hypothesis of this work will be to demonstrate that a complementary training focused on the hip abductor, complementary to concomitant PFMT, would benefit from a more significant improvement in continence, and also in physical abilities and quality of life. Because balance seems involved in UI, we therefore propose to to observe the effects on the frontal balance of the pelvis. As the investigators have already done in previous studies, to identifying factors that predict the success of our interventions, investiagtors have planned to evaluate the observance and adherence of our patients .Complementary, the investigators planned to evaluate the effect of both intervention on pelvic floor muscles and hip abductors strength and endurance, pelvic organ prolapse symptoms and quality of life. For this objective, the investigators intend to compare two randomized parallel groups: Group A follow a 12 sessions supervised PFMT + home based PFMs exercices. Group B follow a 12 sessions supervised PFMT + home based hip abductor exercices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physiotherapist-supervised pelvic floor muscle training | Active comparator | Other: Standard pelvic floor muscle training, Other: Standard pelvic floor muscle training self trainingphysiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training PFMT |
| hip abductors self training program | Experimental | Other: hip abductors physiotherapy self training, Other: Standard pelvic floor muscle trainingphysiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training hip abductors self training program |
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)
- Women ≥ 18 ans
- patient with urinary incontinence according to the ICS criteria [3]
- having received a prescription for perineal rehabilitation
- affiliated to french health care insurance
- Patient having read and understood the information letter and signed the consent form
Key exclusion criteria (7 listed)
- Bladder pathologies (cyst, tumour, interstitial cystitis)
- Neurological pathologies (multiple sclerosis, Parkinson's desease, etc.)
- Pregnant or parturient or breastfeeding woman or absence of proven contraception
- Person deprived of liberty by administrative or judicial decision or a person placed under the safeguard of justice, or guardianship or curatorship
- Physical inability to perform hip abductors exercises (unable to walk or stand independently)
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 abductors physiotherapy self traininghip abductors self training program during 7 to 10 weeks associate with a PFMT | Other | hip abductors self training program |
| Standard pelvic floor muscle trainingStandard pelvic floor muscle training | Other | hip abductors self training program, physiotherapist-supervised pelvic floor muscle training |
| Standard pelvic floor muscle training self trainingStandard pelvic floor muscle training self training | Other | physiotherapist-supervised pelvic floor muscle training |
Primary outcome
The difference in the number of leaks per week observed after the end of treatment between the two arms at the last physiotherapy session.
Time frame: 10 weeks
This number of leaks per week will be recorded using question 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF).
14 secondary outcomes
Measurement in centimeters of the offset in the frontal plane of the postero-superior iliac spines during a one leg stance
Time frame: 10 weeks
Average of the measurement in Newton of the force of the hip abductors during a maximum manual resistance test repeated 3 times using a dynamometer
Time frame: 10 weeks
Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times
Time frame: 10 weeks
Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing
Time frame: 10 weeks
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire
Time frame: 10 weeks
Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire
Time frame: 10 weeks
Short Form-36 Quality of Life overall score and subscores
Time frame: 10 weeks
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Time frame: 10 weeks
Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment)
Time frame: 10 weeks
Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment)
Time frame: 10 weeks
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire questionnaire
Time frame: through study completion, an average of 6 month
Overall score and sub-scores of urinary symptoms of the Prolapsus Quality of Life questionnaire 3. SF-36 Quality of Life overall score and subscores
Time frame: throught study completion, an average of 6 month
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Time frame: throught study completion, an average of 6 month
Score du questionnaire Patient Global Impression of Improvement (PGI-I)
Time frame: throught study completion, an average of 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 24140547Stewart WF, Hirsh AG, Kirchner HL, Clarke DN, Litchtenfeld MJ, Minassian VA. Urinary incontinence incidence: quantitative meta-analysis of factors that explain variation. J Urol. 2014 Apr;191(4):996-1002. doi: 10.1016/j.juro.2013.10.050. Epub 2013 Oct 16.
- Background: PubMed 23721491Ebbesen MH, Hunskaar S, Rortveit G, Hannestad YS. Prevalence, incidence and remission of urinary incontinence in women: longitudinal data from the Norwegian HUNT study (EPINCONT). BMC Urol. 2013 May 30;13:27. doi: 10.1186/1471-2490-13-27.
- Background: PubMed 32964401Pizzol D, Demurtas J, Celotto S, Maggi S, Smith L, Angiolelli G, Trott M, Yang L, Veronese N. Urinary incontinence and quality of life: a systematic review and meta-analysis. Aging Clin Exp Res. 2021 Jan;33(1):25-35. doi: 10.1007/s40520-020-01712-y. Epub 2020 Sep 22.
- 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.
- Steenstrup B, M. Pavy Lebrun, Aigueperse N, Quemener N, Cheveau S, Confalonieri C, Totte F. Efficacité d'une rééducation sensori-motrice posturale réflexe sur l'incontinence urinaire et l'urgenturie chez la femme. Kinesith Rev. 2019;19(206):12-18Link provided by the sponsor.
- Steenstrup B, Behague L, Quehen M. Rééducation posturale avec le jeu virtuel Wii ® en pelvi périnéologie: pourquoi pas? Kinésith Rev. 2015;15(160):45-50Link provided by the sponsor.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hip abductors physiotherapy self training, Standard pelvic floor muscle training and Standard pelvic floor muscle training self training in people with Women With Stress Urinary Incontinence, run by University Hospital, Rouen at 3 sites in France.
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 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit STEENSTRUP, physiotherapist (+33 2 32 88 89 90, benoit.stennstrup@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the number of leaks per week observed after the end of treatment between the two arms at the last physiotherapy session. (time frame: 10 weeks). 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 NCT05635175, which also lists 4 linked publications.
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 8 Jun 2026.