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

October 6, 2022 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • University Hospital of Besancon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of incontinence after surgery (1 year)
Time Frame: 1 year
mesured with pad test on 3 days
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Emilie CERUTTI, University Hospital of Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/664

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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