Clinical trial NCT05635175: Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence
Official title: Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Women With Stress Urinary Incontinence
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: GIRCI NO
First posted: 2022-12-02
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: 10 weeks
Secondary outcomes:
measure: Measurement in centimeters of the offset in the frontal plane of the postero-superior iliac spines during a one leg stance
timeFrame: 10 weeks
measure: 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
timeFrame: 10 weeks
measure: Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times
timeFrame: 10 weeks
measure: Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing
timeFrame: 10 weeks
measure: Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire
timeFrame: 10 weeks
measure: Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire
timeFrame: 10 weeks
measure: Short Form-36 Quality of Life overall score and subscores
timeFrame: 10 weeks
measure: Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
timeFrame: 10 weeks
measure: Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment)
timeFrame: 10 weeks
measure: Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment)
timeFrame: 10 weeks
measure: Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire questionnaire
timeFrame: through study completion, an average of 6 month
measure: 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
timeFrame: throught study completion, an average of 6 month
measure: Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
timeFrame: throught study completion, an average of 6 month
measure: Score du questionnaire Patient Global Impression of Improvement (PGI-I)
timeFrame: throught study completion, an average of 6 month
Other outcomes:
Locations:
city: Caen
country: France
facility: Pôle santé de la Grace Dieu
city: Rouen
country: France
facility: Chu Rouen
city: Saint-Étienne-du-Rouvray
country: France
facility: Médipôle du Rouvray
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.