Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence

NCT05635175 | Recruiting

• 1 other identifier: 2020/0176/HP
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief 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 . 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• 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

  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

  10 weeks

Study Arms (2)

physiotherapist-supervised pelvic floor muscle training

ACTIVE COMPARATOR

physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training PFMT

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

Other: hip abductors physiotherapy self training; Other: Standard pelvic floor muscle training

Interventions

hip abductors physiotherapy self training OTHER

hip abductors self training program during 7 to 10 weeks associate with a PFMT

hip abductors self training program

Standard pelvic floor muscle training OTHER

Standard pelvic floor muscle training

hip abductors self training program; physiotherapist-supervised pelvic floor muscle training

Standard pelvic floor muscle training self training OTHER

Standard pelvic floor muscle training self training

physiotherapist-supervised pelvic floor muscle training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• GIRCI NO: collaborator

Study Sites (3)

Pôle santé de la Grace Dieu

Caen, France

RECRUITING

Chu Rouen

Rouen, France

RECRUITING

Médipôle du Rouvray

Saint-Étienne-du-Rouvray, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 24140547 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.

  PMID: 23721491 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.

  PMID: 32964401 BACKGROUND

• 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.

  PMID: 39704322 DERIVED

Related Links

• 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
• 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

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 2, 2022
• Study Start: September 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)