Urinary Incontinence,StressProtofoamNCT04390204
Evaluation of the Effect of a Postural Reflex Rehabilitation Program on a Foam Surface on Stress Urinary Incontinence in Women
A study testing intervenions in people with Urinary Incontinence,Stress, run by University Hospital, Rouen at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- intervenions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Sep 2021to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 9≥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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cabinet Rééducation Grabels
Grabels, 34 790
cabinet de rééducation LINGOLSHEIM
Lingolsheim, 67380
Cabinet Rééducation Poitiers
Poitiers, 86000
CHU de ROUEN
Rouen, 76 000
cabinet SCM feeling
Saint-Étienne-du-Rouvray, 76 800
About this study
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.
Read more
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
- Being tested
- intervenions
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervenionsOther
- Motor control exercises
- A supervised home self-rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Urinary Symptom Profil (USP) questionnaire, higher scores mean a worse outcome (0-40).
Measured: 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
The MOS 36-item short-form health survey (SF-36 questionnaire) + International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ) ICIQ-SF (Scoring scale: 0-21) higher scores mean a worse outcome .
Measured: 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
Evaluation of the improvement of urinary symptoms using the Patient Global Impression of Improvement scale (PGI I) , higher scores mean a worse outcome (1-7).
Measured: 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
Assessment of low back pelvic pain using the Oswestry Disability Index questionnaire, higher scores mean a worse outcome (0-50).
Measured: 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
Evaluation of compliance with exercises and acceptance of treatment using the "compliance and acceptance" questionnaire
Measured: 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 in terms of exercise compliance and acceptance of treatment
Pelvic comfort assessment using the Pelvic Floor Distress Inventory (PFID-20) questionnaire higher scores mean a worse outcome (0-80)
Measured: through study completion, an average of 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start21 Sep 2021
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390204
- Sponsor's protocol ID
- 2017/389/HP
- Acronym
- Protofoam
- Status last verified
- Feb 2026
- First submitted
- 6 May 2020
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Postural Reflex Rehabilitation Program on a Foam Surface on Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT04390204
- Acronym / sponsor ID
- Protofoam / 2017/389/HP
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: intervenionsMotor 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 9≥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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervenions* Motor control exercises * A supervised home self-rehabilitation program | Other | Experimental |
Primary outcome
demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface to reduce stress urinary incontinence in women
Time frame: through study completion, an average of 26 months
difference in volume of urinary leaks before and after the supervised exercise protocol, measured during a standardized stress pad test
6 secondary outcomes
Demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface on urinary symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 in terms of exercise compliance and acceptance of treatment
Time frame: through study completion, an average of 26 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 39704322Hay-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervenions in people with Urinary Incontinence,Stress, run by University Hospital, Rouen at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demonstrate the effectiveness of a reflex postural control rehabilitation program with supervised exercises on a foam surface to reduce stress urinary incontinence in women (time frame: through study completion, an average of 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.