Evaluation of the Effect of a Postural Reflex Rehabilitation Program on a Foam Surface on Stress Urinary Incontinence in Women

NCT04390204 | Completed

• 1 other identifier: 2017/389/HP
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 5

Brief Summary

Urinary incontinence is defined by the International Continence Society as "any involuntary loss of urine complained by the patient". UI is a debilating condition affecting 25% to 45% of the female population. It is a recognized factor impairing the women's quality of life in women. Age, type and severity of UI as well as stress, fears and beliefs are variables that significantly affect the quality of life scores . Its costs are estimated at 2% of the health budget in European countries. Stress urinary incontinence (SUI) is characterized by a loss of urine that occurs with increased intra-abdominal pressure, such as coughing, laughing, sneezing, jumping, running, lifting loads or any other physical activity . SUI accounts for 50% of UI types. For HAS (Haute Autorité de Santé), the first-line treatment is a conservative, non-medicinal and non-surgical treatment. Hay Smith's 2010 literature review concludes that pelvic floor muscle rehabilitation (PMP) must be the first-line treatment for SUI. However, there is a lack of evidence to define the best treatment regimen for PFM rehabilitation. For 25 years, we have been performing assessment and rehabilitation programs for urinary incontinence. We see daily, as literature suggests, a link between continence and postural control. Previous studies, such as that we carried out within our service, tend to confirm the positive impact of reflex postural control on continence. Our team has already shown the feasibility of such a program and its effectiveness on stress urinary incontinence. Foam surfaces are devices used in the rehabilitation of reflex postural control. Several studies have shown that rehabilitation programs on foam surfaces improve reflex postural control better than the same exercises on stable ground. Smith et al. have shown impaired motor control of MPP on foam surfaces in women with stress urinary incontinence. However, the effect of a rehabilitation program with foam surface on urinary symptoms has never been evaluated. For our main outcome, we propose to follow the recommendations of L. Rimstad in his recent prospective study of SUI assessment in 147 subjects aged 36 to 63 years, wich seems more in accordance with postural control disorder than the "gold standard" supine cough test wich has been found to have low sensitivity. The test pad on a trampoline allows to object a SUI in 91% of the negative patients to the test pad on firm surface. It therefore makes it possible to object stress urinary incontinence without invasive urodynamic investigations. It therefore seems justified for the comfort of our patients and the relevance of our results. The preliminary assessments and the skills of the physiotherapist make it possible to assess the patient's ability to perform this test. Our experience of carrying out trampoline tests or exercises for 25 years, as of the Rimstad team in the context of the treatment of SUI for 10 years, allows us to carry out this test in good conditions of efficiency , comfort and safety. Thus, we hypothesize that a rehabilitation program by supervised reflex postural control exercises on a foam surface can reduce the volume of urinary leakage in women. This study will also show the influence of such a program on symptoms and quality of life in women with urinary incontinence. Innovative nature of our study We do not find in the literature any evaluation of the effectiveness of exercises on foam surface on stress urinary incontinence Our protocol, by its minimally invasive nature, would promote a better emotional experience for our patients Most studies in the context of incontinence are based on a semi-objective outcome assessment with symptoms questionnaire. We suggest using the short stress pad test, a more objective test for women, recommended by several authors We will observe the impact of our protocol on pelvic and low back pain, quality of life and any restrictions on social participations We hope to confirm the best acceptance of non-invasive treatments, without intravaginal probe in continence rehabilitation Our protocol goes in the direction of:

• Literature reviews on urinary incontinence through supervised group sessions
• WHO's recommendations on the maintenance of balance and physical functions, and also the prevention of falls in adults

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (1)

• demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface to reduce stress urinary incontinence in women

  difference in volume of urinary leaks before and after the supervised exercise protocol, measured during a standardized stress pad test

  through study completion, an average of 26 months

Secondary Outcomes (6)

• Demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface on urinary symptoms

  through study completion, an average of 26 months

• Demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface on quality of life

  through study completion, an average of 26 months

• Demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface on improvement of urinary symptoms

  through study completion, an average of 26 months

• Demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface low back pain

  through study completion, an average of 26 months

• emonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface on pelvic comfort

  through study completion, an average of 26 months

Study Arms (2)

Experimental

EXPERIMENTAL

Motor control exercises are performed on foam mats. The physiotherapist instructs them, and gives a description on paper, as well as a USB key allowing to view the exercises on video. A supervised home self-rehabilitation program on foam mats is implemented.

Other: intervenions

control

NO INTERVENTION

According to the recommendations of learned societies, patients are offered voluntary MPP contraction work, in strength and endurance, in increasing complexity, under manual endocavitary control and under biofeedback. A supervised program of self-rehabilitation at home by voluntary contraction of MPP is set up.

Interventions

intervenions OTHER

* Motor control exercises * A supervised home self-rehabilitation program

Experimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18
• Patient with urinary incontinence according to the ICS criteria
• Patient affiliated to social security
• Patient having read and understood the information letter and signed the consent form
• Woman of childbearing age with effective contraception or menopausal status

You may not qualify if:

• Neurological, psychiatric and digestive pathology wich induces stress urinary incontinence
• Pregnant or parturient or lactating woman
• Person deprived of liberty by administrative or judicial decision or a person placed under the safeguard of justice, or guardianship or curatorship
• Anti-cholinergic treatment initiated less than 3 months ago
• Patient unable to complete the 15 planned visits to physiotherapist
• Patient participating in another clinical trial
• Patient unable to perform the first stress test pad
• No urinary leakage noted during the stress pad test (difference of weight before and after protection pad test = 0 g)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (5)

Cabinet Rééducation Grabels

Grabels, 34 790, France

Location

cabinet de rééducation LINGOLSHEIM

Lingolsheim, 67380, France

Location

Cabinet Rééducation Poitiers

Poitiers, 86000, France

Location

CHU de ROUEN

Rouen, 76 000, France

Location

cabinet SCM feeling

Saint-Étienne-du-Rouvray, 76 800, France

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 15, 2020
• Study Start: September 21, 2021
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

FR (5)