Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy (PROTOMEN)
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|ClinicalTrials.gov Identifier: NCT03027986|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2017
Last Update Posted : May 28, 2018
Urinary incontinence (UI) is defined by the International Continence Society as "any involuntary loss of urine complained by the patient". The anatomical and histological specificities of the pelvic floor muscles (PFM) give them a key role in the control of urination but also in the control of postural stability. These activities are involuntary automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence are not only due to the loss of voluntary contraction of the pelvic floor muscles. The mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack of evidence to define the best treatment regimen for PFM rehabilitation.
Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.
- The first one is made in individual box, in supine position. By analytic contractions of the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This method used voluntary contractions of MPP.
- The second is realized in various positions following a gravity progression, in individual and /or common room. This technique aims to restore a stabilization of the entire lumbo-pelvic region by postural recruitment involving synergistic contractions of the PFM.
These trials propose to compare these two rehabilitation programs on populations with postoperative follow-up of more than 12 months.
We chose to objectify the urine leaks with the pad test (weighing of the protections urinary over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad of 3 times in 24 hours has been used by numerous studies and its reproducibility and reliability are established.
Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental health and decreased of physical fitness. We therefore wish to observe these parameters for each of our two randomized groups
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Prostate Cancer||Behavioral: postural rehabilitation program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
|Experimental: postural rehabilitation program based on sensory-motor control||
Behavioral: postural rehabilitation program
This program is based on sensory-motor control
|No Intervention: Standard physiotherapy|
- Difference from baseline in urine leakage [ Time Frame: 6 months ]urine leakage will be measured using pad test
- Difference from baseline in The Berg balance scale test [ Time Frame: 6 months ]The Berg balance scale test evaluating the quality of static and dynamic motor control.
- Difference from baseline in quality of life [ Time Frame: 6 months ]quality of life is based on EORTC QLQ C30
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027986
|Contact: Benoît STEENSTRUP||023288 ext firstname.lastname@example.org|
|Contact: Julien BLOTemail@example.com|
|Rouen University Hospital||Not yet recruiting|
|Contact: Benoit STEENSTRUP firstname.lastname@example.org|
|Sub-Investigator: Jean-Nicolas CORNU, Pr|
|Principal Investigator:||Benoît STEENSTRUP||Rouen University Hospital|