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

University Hospital, Rouen

Status: Not yet enrolling

Conditions: Women With Stress Urinary Incontinence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05635175

2020 0176 HP

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

physiotherapist-supervised pelvic floor muscle training

Active Comparator group

Description:

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

Treatment:

Other: Standard pelvic floor muscle training self training

Other: Standard pelvic floor muscle training

hip abductors self training program

Experimental group

Description:

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

Treatment:

Other: hip abductors physiotherapy self training

Other: Standard pelvic floor muscle training