Urinary IncontinencePROTOMENNCT03027986
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
A study testing postural rehabilitation program in people with Urinary Incontinence and Prostate Cancer, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years, men only
- Conditions the study is for
- Urinary Incontinence, Prostate Cancer
- What is being tested?
- postural rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2017to 14 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
- 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
- Being tested
- postural rehabilitation program
- Medical subject headings
- Urinary Incontinence, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postural rehabilitation programBehavioural
This program is based on sensory-motor control
| Study group | Role | What they receive |
|---|---|---|
| postural rehabilitation program based on sensory-motor control | Experimental | Not described Receives: Behavioral: postural rehabilitation program |
| Standard physiotherapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline in urine leakage
urine leakage will be measured using pad test
Measured: 6 months
Secondary outcomes (2)
Difference from baseline in The Berg balance scale test
The Berg balance scale test evaluating the quality of static and dynamic motor control.
Measured: 6 months
Difference from baseline in quality of life
quality of life is based on EORTC QLQ C30
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start2 Oct 2017
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Why it stopped: Study population didn't exist yet
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît STEENSTRUP, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027986
- Sponsor's protocol ID
- 2015/210/HP
- Acronym
- PROTOMEN
- Status last verified
- May 2018
- First submitted
- 19 Jan 2017
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
- ClinicalTrials.gov ID
- NCT03027986
- Acronym / sponsor ID
- PROTOMEN / 2015/210/HP
- Conditions
- Urinary Incontinence, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study population didn't exist yet
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postural rehabilitation program based on sensory-motor control | Experimental | Behavioral: postural rehabilitation program |
| Standard physiotherapy | No intervention | – |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postural rehabilitation programThis program is based on sensory-motor control | Behavioural | postural rehabilitation program based on sensory-motor control |
Primary outcome
Difference from baseline in urine leakage
Time frame: 6 months
urine leakage will be measured using pad test
2 secondary outcomes
Difference from baseline in The Berg balance scale test
Time frame: 6 months
Difference from baseline in quality of life
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît STEENSTRUP principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postural rehabilitation program in people with Urinary Incontinence and Prostate Cancer, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference from baseline in urine leakage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.