Prostate CancerPROSTABDONCT05432687
Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)
A study testing evaluation of deep abdominal wall before surgery in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- evaluation of deep abdominal wall before surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to Oct 2025
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy
Who cannot join
- neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
- urinary incontinence before surgery
- surgery for abdominal wallhernia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital of Besançon
Besançon, 25000
Emilie CERUTTI, 0381218876, ecerutti@chu-besancon.fr
About this study
Official title: Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie
the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.
- Conditions
- Prostate Cancer
- Being tested
- evaluation of deep abdominal wall before surgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of deep abdominal wall before surgeryDiagnostic test
: cough test (L guillarme) + ulstrasonography of transversus abdominis
| Study group | Role | What they receive |
|---|---|---|
| patient before Robotic-assisted Radical Prostatectomy | Other | evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis Receives: Diagnostic Test: evaluation of deep abdominal wall before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of incontinence after surgery (1 year)
mesured with pad test on 3 days
Measured: 1 year
Secondary outcomes (6)
amount of incontinence after 3 month
mesured with pad test on 3 days
Measured: 3 month
amount of incontinence after 6 month
mesured with pad test on 3 days
Measured: 6 month
quality of life after 3 month
Short-Form (SF-36) Health Survey
Measured: 3 month
quality of life after6 month
Short-Form (SF-36) Health Survey
Measured: 6 month
quality of life after 12 month
Short-Form (SF-36) Health Survey
Measured: 12 month
quality of incontinence after 12 month
mesured with urinary symptom profil score
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Sep 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie CERUTTI, Principal investigator, University hospital of Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432687
- Sponsor's protocol ID
- 2021/664
- Acronym
- PROSTABDO
- Status last verified
- Dec 2021
- First submitted
- 13 Jun 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie
- ClinicalTrials.gov ID
- NCT05432687
- Acronym / sponsor ID
- PROSTABDO / 2021/664
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Jun 2022 (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.
the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient before Robotic-assisted Radical Prostatectomy | Other | Diagnostic Test: evaluation of deep abdominal wall before surgeryevaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy
Key exclusion criteria (3 listed)
- neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
- urinary incontinence before surgery
- surgery for abdominal wallhernia
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 |
|---|---|---|
| evaluation of deep abdominal wall before surgery: cough test (L guillarme) + ulstrasonography of transversus abdominis | Diagnostic test | patient before Robotic-assisted Radical Prostatectomy |
Primary outcome
amount of incontinence after surgery (1 year)
Time frame: 1 year
mesured with pad test on 3 days
6 secondary outcomes
amount of incontinence after 3 month
Time frame: 3 month
amount of incontinence after 6 month
Time frame: 6 month
quality of life after 3 month
Time frame: 3 month
quality of life after6 month
Time frame: 6 month
quality of life after 12 month
Time frame: 12 month
quality of incontinence after 12 month
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
Emilie CERUTTI principal investigator
University hospital of Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of deep abdominal wall before surgery in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Besancon 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie CERUTTI (0381218876, ecerutti@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of incontinence after surgery (1 year) (time frame: 1 year). 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 7 Oct 2022.