NCT05432687

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 7, 2022

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

June 13, 2022

Last Update Submit

October 6, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • amount of incontinence after surgery (1 year)

    mesured with pad test on 3 days

    1 year

Secondary Outcomes (6)

  • amount of incontinence after 3 month

    3 month

  • amount of incontinence after 6 month

    6 month

  • quality of life after 3 month

    3 month

  • quality of life after6 month

    6 month

  • quality of life after 12 month

    12 month

  • +1 more secondary outcomes

Study Arms (1)

patient before Robotic-assisted Radical Prostatectomy

OTHER

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

Diagnostic Test: evaluation of deep abdominal wall before surgery

Interventions

evaluation of deep abdominal wall before surgeryDIAGNOSTIC_TEST

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

patient before Robotic-assisted Radical Prostatectomy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy

You may not qualify if:

  • neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
  • urinary incontinence before surgery
  • surgery for abdominal wallhernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Emilie CERUTTI

    University hospital of Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie CERUTTI

CONTACT

0381218876ecerutti@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 27, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2025

Last Updated

October 7, 2022

Record last verified: 2021-12

Locations

FR(1)