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NCT Number: NCT05635175

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pôle santé de la Grace Dieu, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hip abductors physiotherapy self training

Other

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

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

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.

    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).

Secondary outcomes

  1. 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

  2. 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

  3. Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times

    Time frame: 10 weeks

  4. Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing

    Time frame: 10 weeks

  5. Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire

    Time frame: 10 weeks

    min: 0 : better outcome max : 21 worse outcome

  6. Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire

    Time frame: 10 weeks

  7. Short Form-36 Quality of Life overall score and subscores

    Time frame: 10 weeks

  8. Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire

    Time frame: 10 weeks

  9. Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment)

    Time frame: 10 weeks

  10. Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment)

    Time frame: 10 weeks

  11. 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

  12. 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

  13. 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

  14. Score du questionnaire Patient Global Impression of Improvement (PGI-I)

    Time frame: throught study completion, an average of 6 month

    min: 1 better outcome max : 7 worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit STEENSTRUP, physiotherapist

CONTACT

[email protected]

+33 2 32 88 89 90

Déborah LEBEDIEFF

CONTACT

[email protected]

+33 2 32 88 89 90

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • GIRCI NO

Registry information

Acronym: PROTOGLUT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.