Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO) (PROSTABDO)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
evaluation of deep abdominal wall before surgery
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy
Exclusion Criteria:
- neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
- urinary incontinence before surgery
- surgery for abdominal wallhernia
Sites / Locations
- University hospital of BesançonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient before Robotic-assisted Radical Prostatectomy
Arm Description
evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis
Outcomes
Primary Outcome Measures
amount of incontinence after surgery (1 year)
mesured with pad test on 3 days
Secondary Outcome Measures
amount of incontinence after 3 month
mesured with pad test on 3 days
amount of incontinence after 6 month
mesured with pad test on 3 days
quality of life after 3 month
Short-Form (SF-36) Health Survey
quality of life after6 month
Short-Form (SF-36) Health Survey
quality of life after 12 month
Short-Form (SF-36) Health Survey
quality of incontinence after 12 month
mesured with urinary symptom profil score
Full Information
NCT ID
NCT05432687
First Posted
June 13, 2022
Last Updated
October 6, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT05432687
Brief Title
Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)
Acronym
PROSTABDO
Official Title
Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient before Robotic-assisted Radical Prostatectomy
Arm Type
Other
Arm Description
evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis
Intervention Type
Diagnostic Test
Intervention Name(s)
evaluation of deep abdominal wall before surgery
Intervention Description
: cough test (L guillarme) + ulstrasonography of transversus abdominis
Primary Outcome Measure Information:
Title
amount of incontinence after surgery (1 year)
Description
mesured with pad test on 3 days
Time Frame
1 year
Secondary Outcome Measure Information:
Title
amount of incontinence after 3 month
Description
mesured with pad test on 3 days
Time Frame
3 month
Title
amount of incontinence after 6 month
Description
mesured with pad test on 3 days
Time Frame
6 month
Title
quality of life after 3 month
Description
Short-Form (SF-36) Health Survey
Time Frame
3 month
Title
quality of life after6 month
Description
Short-Form (SF-36) Health Survey
Time Frame
6 month
Title
quality of life after 12 month
Description
Short-Form (SF-36) Health Survey
Time Frame
12 month
Title
quality of incontinence after 12 month
Description
mesured with urinary symptom profil score
Time Frame
12 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy
Exclusion Criteria:
neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
urinary incontinence before surgery
surgery for abdominal wallhernia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie CERUTTI
Phone
0381218876
Email
ecerutti@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie CERUTTI
Organizational Affiliation
University hospital of Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie CERUTTI
Phone
0381218876
Email
ecerutti@chu-besancon.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)
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