Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy (VITALITE)

March 26, 2026 updated by: University Hospital Center of Martinique

Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy (RP): "Vitality", an Onco-sexology Program

The paramedic urology team at Martinique University Hospital has developed a "personalized rehabilitation oncosexology program for patients undergoing radical prostatectomy (RP) for localized prostate cancer". The aim of this project is to assess the effectiveness of this program by comparing the sexual quality of life 1 year after surgery between patients participating and those who do not.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

80% of patients undergoing radical prostatectomy report urinary incontinence and erectile dysfunction [Johanssen et al. 2011. Scandinavian Prostate Cancer Group Study]. In the West Indies, the incidence of prostate cancer is one of the highest in the world (World-standardized incidence in Martinique is 164.5 versus 88.8 per 100,000 person-years in Metropolitan France). Over 2007-2014 an average 530 new cases of prostate cancer were diagnosed each year in Martinique, representing 55% of all male cancers [Regional estimates report Public Health France, January 2018]. The prostate is a symbol of male vulnerability [French Association of Urology-Global Market Research and Public Opinion Specialist, 2006]. For other authors, virility is above all a cultural representation, and the "crisis of virility", a recomposition of male identity. Surgery on a sexual organ can alter body image and masculinity. According to Colson et al., patients treated for prostate cancer and their partners clearly place sex in first place in the importance of quality of life domains.

Study Type

Interventional

Enrollment (Actual)

135

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 Locations

  • Martinique
      • Fort-de-France, Martinique, 97261
        • Centre Hospitalier Universitaire de Martinique

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

Description

Inclusion Criteria:

  • Men diagnosed with localized prostate cancer and consulting in the urology department of Mangot Vulcin site of the Martinique University Hospital
  • Patients newly diagnosed for prostate cancer and who will benefit from radical prostatectomy (regardless the technique : laparotomy, laparoscopy or robot-assisted micro-invasive surgery)
  • Fluent in French or Creole
  • Patients who give consent
  • Patients affiliated to social security

Exclusion Criteria:

  • Patients diagnosed with another tumor
  • Person under legal protection

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oncosexology program
Several workshops before and after the radical prostatectomy
Behavioral: Oncosexology program
Thematic workshops throughout the year
No Intervention: Usual care
Usual care of the urology department for patients with prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sexual Quality of Life: Questionnaire
Time Frame: Before the radical prostatectomy
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Before the radical prostatectomy
Evaluation of sexual Quality of Life: Questionnaire
Time Frame: 1 Month after the radical prostatectomy
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
1 Month after the radical prostatectomy
Evaluation of sexual Quality of Life: Questionnaire
Time Frame: 12 months after the radical prostatectomy
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
12 months after the radical prostatectomy
Evaluation of sexual function: Questionnaire
Time Frame: Before the radical prostatectomy
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Before the radical prostatectomy
Evaluation of sexual function: Questionnaire
Time Frame: 1 Month after the radical prostatectomy
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
1 Month after the radical prostatectomy
Evaluation of sexual function: Questionnaire
Time Frame: 12 months after the radical prostatectomy
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
12 months after the radical prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life in its multidimensional aspect
Time Frame: Before the radical prostatectomy
Administration of quality of life questionnaire (EORTC QLC C30 questionnaires)
Before the radical prostatectomy
Evaluation of quality of life for localized forms of prostate cancer
Time Frame: Before the radical prostatectomy
Administration of QLQ-PR25 questionnaire (specific module intended for localized forms of prostate cancer. It is complementary to QLQ-C30 and better suited to measure the side effects of treatment.)
Before the radical prostatectomy
Evaluation of quality of life in its multidimensional aspect
Time Frame: 12 Month after the radical prostatectomy
Administration of quality of life questionnaire (EORTC QLC C30 questionnaires)
12 Month after the radical prostatectomy
Evaluation of quality of life for localized forms of prostate cancer
Time Frame: 12 Month after the radical prostatectomy
Administration of QLQ-PR25 questionnaire ((specific module intended for localized forms of prostate cancer. It is complementary to QLQ-C30 and better suited to measure the side effects of treatment.)
12 Month after the radical prostatectomy

Collaborators and Investigators

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

Sponsor

University Hospital Center of Martinique

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)

March 31, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21_RIPH2-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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