Clinical trial NCT03027986: Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
Official title: Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Prostate Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Difference from baseline in urine leakage
timeFrame: 6 months
Secondary outcomes:
measure: Difference from baseline in The Berg balance scale test
timeFrame: 6 months
measure: Difference from baseline in quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Benoît STEENSTRUP
role: PRINCIPAL_INVESTIGATOR
References: