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Trial record 60 of 150 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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


Condition or disease Intervention/treatment Phase
Urinary Incontinence Prostate Cancer Behavioral: postural rehabilitation program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Difference from baseline in urine leakage [ Time Frame: 6 months ]
    urine leakage will be measured using pad test


Secondary Outcome Measures :
  1. 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.

  2. Difference from baseline in quality of life [ Time Frame: 6 months ]
    quality of life is based on EORTC QLQ C30



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   this medical condition for participation is patient with a prostatectomy
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Benoît STEENSTRUP 023288 ext 8990 benoit.steenstrup@orange.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Not yet recruiting
Rouen, France
Contact: Benoit STEENSTRUP       benoit.steenstrup@orange.fr   
Sub-Investigator: Jean-Nicolas CORNU, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Benoît STEENSTRUP Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03027986     History of Changes
Other Study ID Numbers: 2015/210/HP
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders