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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: evaluation of deep abdominal wall before surgery

• Registration Number: NCT05432687
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Study Start: 2022-09-01
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07
• Primary Completion: 2023-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient before Robotic-assisted Radical Prostatectomy	evaluation of deep abdominal wall before surgery	evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis

Primary Outcome Measures

Name	Time	Method
amount of incontinence after surgery (1 year)	1 year	mesured with pad test on 3 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University hospital of Besançon; 🇫🇷 Besançon, France