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

Primary Purpose

Women With Stress Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hip abductors physiotherapy self training
Standard pelvic floor muscle training
Standard pelvic floor muscle training self training
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Women With Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Pôle santé de la Grace Dieu
  • Chu Rouen
  • Médipôle du Rouvray

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

physiotherapist-supervised pelvic floor muscle training

hip abductors self training program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Measurement in centimeters of the offset in the frontal plane of the postero-superior iliac spines during a one leg stance
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
Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times
Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire
min: 0 : better outcome max : 21 worse outcome
Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire
Short Form-36 Quality of Life overall score and subscores
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment)
Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment)
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire questionnaire
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
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Score du questionnaire Patient Global Impression of Improvement (PGI-I)
min: 1 better outcome max : 7 worse outcome

Full Information

First Posted
November 3, 2022
Last Updated
March 9, 2023
Sponsor
University Hospital, Rouen
Collaborators
GIRCI NO
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1. Study Identification

Unique Protocol Identification Number
NCT05635175
Brief Title
Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence
Acronym
PROTOGLUT
Official Title
Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
GIRCI NO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
physiotherapist-supervised pelvic floor muscle training
Arm Type
Active Comparator
Arm Description
physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training PFMT
Arm Title
hip abductors self training program
Arm Type
Experimental
Arm Description
physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) and self training hip abductors self training program
Intervention Type
Other
Intervention Name(s)
hip abductors physiotherapy self training
Intervention Description
hip abductors self training program during 7 to 10 weeks associate with a PFMT
Intervention Type
Other
Intervention Name(s)
Standard pelvic floor muscle training
Intervention Description
Standard pelvic floor muscle training
Intervention Type
Other
Intervention Name(s)
Standard pelvic floor muscle training self training
Intervention Description
Standard pelvic floor muscle training self training
Primary Outcome Measure Information:
Title
The difference in the number of leaks per week observed after the end of treatment between the two arms at the last physiotherapy session.
Description
This number of leaks per week will be recorded using question 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Average of measurement in seconds of the hip abductors resistance during a manual resistance test repeated 10 times
Time Frame
10 weeks
Title
Measurement rated from 1 to 5 of the strength of PFMs according to the "Modified Oxford Grading Scale" testing
Time Frame
10 weeks
Title
Overall score and sub-scores of urinary symptoms from the international consultation on incontinence questionnaire
Description
min: 0 : better outcome max : 21 worse outcome
Time Frame
10 weeks
Title
Overall score and sub-scores of urinary symptoms of the Prolape quality of life questionnaire
Time Frame
10 weeks
Title
Short Form-36 Quality of Life overall score and subscores
Time Frame
10 weeks
Title
Overall score and sub-scores of physical inactivity and physical abilities from the Ricci & Gagnon questionnaire
Time Frame
10 weeks
Title
Overall score and sub-scores of the therapeutic observance and adherence questionnaire (only at the end of treatment)
Time Frame
10 weeks
Title
Patient Global Impression of Improvement (PGI-I) questionnaire score (only at end of treatment)
Time Frame
10 weeks
Title
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
Title
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
Title
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
Title
Score du questionnaire Patient Global Impression of Improvement (PGI-I)
Description
min: 1 better outcome max : 7 worse outcome
Time Frame
throught study completion, an average of 6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoit STEENSTRUP, physiotherapist
Phone
+33 2 32 88 89 90
Email
benoit.stennstrup@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Déborah LEBEDIEFF
Phone
+33 2 32 88 89 90
Email
deborah.lebedieff@chu-rouen.fr
Facility Information:
Facility Name
Pôle santé de la Grace Dieu
City
Caen
Country
France
Facility Name
Chu Rouen
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit STEENSTRUP, physiotherapist
Phone
+ 33 2 32 88 81 55
Email
benoit.steenstrup@chu-rouen.fr
Facility Name
Médipôle du Rouvray
City
Saint-Étienne-du-Rouvray
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24140547
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.
Results Reference
background
PubMed Identifier
23721491
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.
Results Reference
background
PubMed Identifier
32964401
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.
Results Reference
background
Links:
URL
https://doi.org/10.1016/j.kine.2018.11.005
Description
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
URL
https://doi.org/10.1016/j.kine.2014.11.087
Description
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

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

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