NCT06815055

Brief Summary

In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ. No study where found about the clasification and evaluation of those rehabilitation techniques.

Trial Health

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Trial Health Score

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

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

February 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

February 4, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

radical prostatectomyrehabilitationcontinencequality of life

Outcome Measures

Primary Outcomes (1)

  • Set up homogeneous groups of subjects (clusters)

    The primary outcome is a survey questionning the subject about the rehabilitation techniques realised during the post operative period. This survey will be asked during a phone interview directed by investgator.

    It will take place around six months after the surgery.

Interventions

Subjects will be call 1 month and 6 months after prostetectomy to evaluate the type of reeducation received and they will be evaluated with the help of QoL questionnaries : KHQ-HR QoL and ICIQ-SF QoL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population concerned by the study is national french territory. Subjects must have an postoperative follow up performing by an urologist.

You may qualify if:

  • men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma
  • having a follow up postoperative consultation between one and two month after the surgery
  • being able to answer to respond the questions during the interviews
  • agreeing to participate by signing informed consent form

You may not qualify if:

  • undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy
  • Refusing to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Camille Trouillet, Clinical Research Associate

CONTACT

Maxence Mokeddem, Clinical Research Assistant

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 7, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 5, 2025

Record last verified: 2025-06