Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05432687

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: evaluation of deep abdominal wall before surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: patient before Robotic-assisted Radical Prostatectomy evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis	Diagnostic Test: evaluation of deep abdominal wall before surgery : cough test (L guillarme) + ulstrasonography of transversus abdominis

Arm

Intervention/Treatment

Other: patient before Robotic-assisted Radical Prostatectomy

evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis

Diagnostic Test: evaluation of deep abdominal wall before surgery

: cough test (L guillarme) + ulstrasonography of transversus abdominis

Outcome Measures

Primary Outcome Measures

amount of incontinence after surgery (1 year) [1 year]
mesured with pad test on 3 days

Secondary Outcome Measures

amount of incontinence after 3 month [3 month]
mesured with pad test on 3 days
amount of incontinence after 6 month [6 month]
mesured with pad test on 3 days
quality of life after 3 month [3 month]
Short-Form (SF-36) Health Survey
quality of life after6 month [6 month]
Short-Form (SF-36) Health Survey
quality of life after 12 month [12 month]
Short-Form (SF-36) Health Survey
quality of incontinence after 12 month [12 month]
mesured with urinary symptom profil score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05432687

Other Study ID Numbers:

2021/664

First Posted:

Jun 27, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jun 27, 2022