Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy

Prostate Cancer Clinical Trial

— PROTOMEN  

Official title:

Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03027986
• Other study ID #: 2015/210/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: December 2022

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: Benoît STEENSTRUP
• Phone: 023288
• Email: benoit.steenstrup[@]orange.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Urinary Incontinence

Intervention

Behavioral:
• postural rehabilitation program
This program is based on sensory-motor control

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference from baseline in urine leakage	urine leakage will be measured using pad test	6 months
Secondary	Difference from baseline in The Berg balance scale test	The Berg balance scale test evaluating the quality of static and dynamic motor control.	6 months
Secondary	Difference from baseline in quality of life	quality of life is based on EORTC QLQ C30	6 months