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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02148-31 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| GIRCI NO | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physiotherapist-supervised pelvic floor muscle training | Active Comparator | physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training PFMT |
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| hip abductors self training program | Experimental | physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training hip abductors self training program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hip abductors physiotherapy self training | Other | hip abductors self training program during 7 to 10 weeks associate with a PFMT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement in centimeters of the offset in the frontal plane of the postero-superior iliac spines during a one leg stance | 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 |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benoit STEENSTRUP, physiotherapist | Contact | +33 2 32 88 89 90 | benoit.stennstrup@chu-rouen.fr | |
| Déborah LEBEDIEFF | Contact | +33 2 32 88 89 90 | deborah.lebedieff@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle santé de la Grace Dieu | Recruiting | Caen | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24140547 | Background | 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. | |
| 23721491 | Background | Ebbesen 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. |
| Label | URL |
|---|---|
| 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):12-18 | View source |
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| Standard pelvic floor muscle training | Other | Standard pelvic floor muscle training |
|
| Standard pelvic floor muscle training self training | Other | Standard pelvic floor muscle training self training |
|
| 10 weeks |
| Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times | 10 weeks |
| Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing | 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 | 10 weeks |
| Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire | 10 weeks |
| Short Form-36 Quality of Life overall score and subscores | 10 weeks |
| Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire | 10 weeks |
| Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment) | 10 weeks |
| Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment) | 10 weeks |
| Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire questionnaire | 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 | throught study completion, an average of 6 month |
| Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire | 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 | throught study completion, an average of 6 month |
| Chu Rouen | Recruiting | Rouen | France |
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| Médipôle du Rouvray | Recruiting | Saint-Étienne-du-Rouvray | France |
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| 32964401 | Background | Pizzol 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. |
| 39704322 | Derived | 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. |
| Steenstrup B, Behague L, Quehen M. Rééducation posturale avec le jeu virtuel Wii ® en pelvi périnéologie: pourquoi pas? Kinésith Rev. 2015;15(160):45-50 | View source |