Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05266313

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Martinique

Fort-de-France, 97261, Martinique

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oncosexology program

Behavioral

Thematic workshops throughout the year

Primary outcomes

  1. 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)

  2. Evaluation of sexual function: Questionnaire

    Time frame: Before the radical prostatectomy

    Administration of sexual function questionnaire (IIEF-type validated questionnaires)

  3. 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)

  4. Evaluation of sexual function: Questionnaire

    Time frame: 1 Month after the radical prostatectomy

    Administration of sexual function questionnaire (IIEF-type validated questionnaires)

  5. 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)

  6. Evaluation of sexual function: Questionnaire

    Time frame: 12 months after the radical prostatectomy

    Administration of sexual function questionnaire (IIEF-type validated questionnaires)

Secondary outcomes

  1. 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)

  2. 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.)

  3. 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)

  4. 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.)

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Official study title

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

Acronym: VITALITE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.