Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04390204
Status:
UNKNOWN
Last Update Posted:
2020-05-15
First Post:
2020-05-06
Brief Title:
Evaluation of the Effect of a Postural Reflex Rehabilitation Program on a Foam Surface on Stress Urinary Incontinence in Women
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Evaluation of the Effect of a Postural Reflex Rehabilitation Program on a Foam Surface on Stress Urinary Incontinence in Women
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Protofoam
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 womens 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 Smiths 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 patients 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
WHOs recommendations on the maintenance of balance and physical functions and also the prevention of falls in adults
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 Smiths 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 patients 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
WHOs recommendations on the maintenance of balance and physical functions and also the prevention of falls in adults
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None