Men Who Have Undergone ProstatectomyEDULAPRONCT06842914
Postural Training for Standing and Sitting in Men Suffering From Post-prostatectomy Urinary Incontinence
An observational study of Men Who Have Undergone Prostatectomy, run by University Hospital, Rouen at 2 sites in France.
Trial summary
Existing research highlights the difficulty of identifying an optimal rehabilitation technique for improving male urinary continence. However, several authors have demonstrated the benefits of treatment based on improving movement control, often referred to as postural motor contro. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Men Who Have Undergone Prostatectomy
- What is being tested?
- postural training
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2025to 15 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men who have undergone prostatectomy
Who may be able to join
- Men over the age of majority.
- Men who had had a prostatectomy within one year of inclusion.
- Positive response to the question 'Do you leak urine when you stand or sit up?
- Patients with a medical prescription for post-prostatectomy urinary incontinence rehabilitation.
- Patients who are able to understand and follow the instructions relating to postural education when standing up or sitting down.
- Patients who have read and understood the information note and who have not objected to participating in the research.
- Patients affiliated to a social security scheme.
Who cannot join
- Urinary leakage before prostatectomy (diagnosed by a doctor)
- Pad test ≤ 0 grams at the inclusion visit, before showing the postural control technique.
- On anticholinergic treatment initiated less than 3 months ago.
- Impossible to carry out postural control education (spinal surgery, serious neurological or orthopaedic pathology).
- Patients deprived of their liberty by an administrative or judicial decision or protected adults (under guardianship or trusteeship).
- Participation in other interventions: Individuals participating at the same time in other post-prostatectomy rehabilitation programmes or similar clinical studies.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Existing research highlights the difficulty of identifying an optimal rehabilitation technique for improving male urinary continence. However, several authors have demonstrated the benefits of treatment based on improving movement control, often referred to as postural motor contro. The main principles are: respect for the neutral lumbopelvic position, reduction of intra-abdominal constraints and ecology of movement. With the aim of encouraging patient-centred clinical practice, patients are asked to fill in an assessment form on which they note the most disabling gestures with regard to their UI during the initial assessment. In our experience, 'sitting down or getting up from a chair' is the item most frequently and most severely reported. In practical terms, posture and body movements play a vital role in the management of pelvic strain. For example, excessive pressure on the bladder due to poor postural control would increase stress on the bladder. Optimal postural control would have the advantage of reducing and promoting continence mechanisms. If we take the example of the transition from sitting to standing, postural control aims to improve neuromuscular coordination and promote continence.
In the context of health education during the first session, it might be interesting to study the impact of modifying postural control when standing/sitting on urinary incontinence and how patients feel about it.
- Conditions
- Men Who Have Undergone Prostatectomy
- Being tested
- postural training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postural trainingOther
postural training
What is being measured
The primary outcome is the main question the study is designed to answer.
the sign of the difference between the results of the two pad tests of 3 times 24 hours.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men Who Have Undergone ProstatectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842914
- Sponsor's protocol ID
- 2024/0203/OB
- Acronym
- EDULAPRO
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Training for Standing and Sitting in Men Suffering From Post-prostatectomy Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06842914
- Acronym / sponsor ID
- EDULAPRO / 2024/0203/OB
- Conditions
- Men Who Have Undergone Prostatectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- 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.
Existing research highlights the difficulty of identifying an optimal rehabilitation technique for improving male urinary continence. However, several authors have demonstrated the benefits of treatment based on improving movement control, often referred to as postural motor contro. The main principles are: respect for the neutral lumbopelvic position, reduction of intra-abdominal constraints and ecology of movement. With the aim of encouraging patient-centred clinical practice, patients are asked to fill in an assessment form on which they note the most disabling gestures with regard to their UI during the initial assessment. In our experience, 'sitting down or getting up from a chair' is the item most frequently and most severely reported. In practical terms, posture and body movements play a vital role in the management of pelvic strain. For example, excessive pressure on the bladder due to poor postural control would increase stress on the bladder. Optimal postural control would have the advantage of reducing and promoting continence mechanisms. If we take the example of the transition from sitting to standing, postural control aims to improve neuromuscular coordination and promote continence.
In the context of health education during the first session, it might be interesting to study the impact of modifying postural control when standing/sitting on urinary incontinence and how patients feel about it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men who have undergone prostatectomy
Key inclusion criteria (7 listed)
- Men over the age of majority.
- Men who had had a prostatectomy within one year of inclusion.
- Positive response to the question 'Do you leak urine when you stand or sit up?
- Patients with a medical prescription for post-prostatectomy urinary incontinence rehabilitation.
- Patients who are able to understand and follow the instructions relating to postural education when standing up or sitting down.
Key exclusion criteria (6 listed)
- Urinary leakage before prostatectomy (diagnosed by a doctor)
- Pad test ≤ 0 grams at the inclusion visit, before showing the postural control technique.
- On anticholinergic treatment initiated less than 3 months ago.
- Impossible to carry out postural control education (spinal surgery, serious neurological or orthopaedic pathology).
- Patients deprived of their liberty by an administrative or judicial decision or protected adults (under guardianship or trusteeship).
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 trainingpostural training | Other | – |
Primary outcome
the sign of the difference between the results of the two pad tests of 3 times 24 hours.
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Men Who Have Undergone Prostatectomy
Recruiting
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Urinary Incontinence , Stress, Prostatectomy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Men Who Have Undergone Prostatectomy, run by University Hospital, Rouen at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact benoit steenstrup, MKDE (02 32 88 82 65, benoit.steenstrup@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sign of the difference between the results of the two pad tests of 3 times 24 hours. (time frame: 15 days). 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 24 Feb 2025.