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

Prostate Cancer Clinical Trial

— PROSTABDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432687
• Other study ID #: 2021/664
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 2025

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Emilie CERUTTI
• Phone: 0381218876
• Email: ecerutti[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2025
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• evaluation of deep abdominal wall before surgery
: cough test (L guillarme) + ulstrasonography of transversus abdominis

Locations

Country	Name	City	State
France	University hospital of Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of incontinence after surgery (1 year)	mesured with pad test on 3 days	1 year
Secondary	amount of incontinence after 3 month	mesured with pad test on 3 days	3 month
Secondary	amount of incontinence after 6 month	mesured with pad test on 3 days	6 month
Secondary	quality of life after 3 month	Short-Form (SF-36) Health Survey	3 month
Secondary	quality of life after6 month	Short-Form (SF-36) Health Survey	6 month
Secondary	quality of life after 12 month	Short-Form (SF-36) Health Survey	12 month
Secondary	quality of incontinence after 12 month	mesured with urinary symptom profil score	12 month