Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy (PROTOMEN)
Primary Purpose
Urinary Incontinence, Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
postural rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Gender: Male
- Between the age of 18 and 78 years
- Patient who underwent prostatectomy more than 12 months ago but less than 10 years
- 3x24h pad test over or equivalent to 10 grs
- Persistent urinary incontinence beyond 12 month following prostatectomy
- Patient affiliated to social security
- Patient who submitted non-opposition for participation in the study
Exclusion Criteria:
- Patients who underwent prostatectomy or other visceral surgery less than one year ago
- Patient who underwent surgical treatment of urinary incontinence
- Patient with urinary incontinence less than 10g
- Surgery considered within two years of inclusion
- Radio, hormone, or chemotherapy cured or in progress
- Anticholinergic treatment less than 3 months ago
- Patient with neurological or bladder disorders potentially involved in incontinence disorders
- Vestibular or psychiatric pathology making limitations to carry out all the examinations provided for in the protocol
- Patient unable to complete the planned 15 visits to physiotherapist
- Patient participating in another clinical trial
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
postural rehabilitation program based on sensory-motor control
Standard physiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Difference from baseline in urine leakage
urine leakage will be measured using pad test
Secondary Outcome Measures
Difference from baseline in The Berg balance scale test
The Berg balance scale test evaluating the quality of static and dynamic motor control.
Difference from baseline in quality of life
quality of life is based on EORTC QLQ C30
Full Information
NCT ID
NCT03027986
First Posted
January 19, 2017
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT03027986
Brief Title
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
Acronym
PROTOMEN
Official Title
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
postural rehabilitation program based on sensory-motor control
Arm Type
Experimental
Arm Title
Standard physiotherapy
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
postural rehabilitation program
Intervention Description
This program is based on sensory-motor control
Primary Outcome Measure Information:
Title
Difference from baseline in urine leakage
Description
urine leakage will be measured using pad test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference from baseline in The Berg balance scale test
Description
The Berg balance scale test evaluating the quality of static and dynamic motor control.
Time Frame
6 months
Title
Difference from baseline in quality of life
Description
quality of life is based on EORTC QLQ C30
Time Frame
6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
this medical condition for participation is patient with a prostatectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gender: Male
Between the age of 18 and 78 years
Patient who underwent prostatectomy more than 12 months ago but less than 10 years
3x24h pad test over or equivalent to 10 grs
Persistent urinary incontinence beyond 12 month following prostatectomy
Patient affiliated to social security
Patient who submitted non-opposition for participation in the study
Exclusion Criteria:
Patients who underwent prostatectomy or other visceral surgery less than one year ago
Patient who underwent surgical treatment of urinary incontinence
Patient with urinary incontinence less than 10g
Surgery considered within two years of inclusion
Radio, hormone, or chemotherapy cured or in progress
Anticholinergic treatment less than 3 months ago
Patient with neurological or bladder disorders potentially involved in incontinence disorders
Vestibular or psychiatric pathology making limitations to carry out all the examinations provided for in the protocol
Patient unable to complete the planned 15 visits to physiotherapist
Patient participating in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoît STEENSTRUP
Phone
023288
Ext
8990
Email
benoit.steenstrup@orange.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît STEENSTRUP
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit STEENSTRUP
Email
benoit.steenstrup@orange.fr
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas CORNU, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
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