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

NCT03027986 | Withdrawn

• 1 other identifier: 2015/210/HP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Difference from baseline in urine leakage

  urine leakage will be measured using pad test

  6 months

Secondary Outcomes (2)

• Difference from baseline in The Berg balance scale test

  6 months

• Difference from baseline in quality of life

  6 months

Study Arms (2)

postural rehabilitation program based on sensory-motor control

EXPERIMENTAL

Behavioral: postural rehabilitation program

Standard physiotherapy

NO INTERVENTION

Interventions

postural rehabilitation program BEHAVIORAL

This program is based on sensory-motor control

postural rehabilitation program based on sensory-motor control

Eligibility Criteria

• Age: 18 Years - 78 Years
• Gender Eligibility Details: this medical condition for participation is patient with a prostatectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: Male
• Between the age of 18 and 78 years
• Patient who underwent prostatectomy more than 12 months ago but less than 10 years
• x24h 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Study Officials

• Benoît STEENSTRUP

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: October 2, 2017
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: February 17, 2026

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)