Prostate Cancer
Conditions
Keywords
Prostatectomy
Brief summary
Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections. There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.
Interventions
OTHERTherapeutic education
Patients will benefit from the first session of preoperative therapeutic education, then the next 5 sessions will be done postoperatively over a period of 4 month and a half. Session 1: The first session will be devoted appropriately to patient education. It will take place on the day of the preoperative anesthesia consultation. Session 2: day of discharge from hospital. Make the patient adhere to the concept of post PR erectile rehabilitation in the same way as sphincter reeducation. Session 3: Presentation of available treatments, start intracavernous injections. Session 4: Acquisition of know-how on treatment management. Reduce anxiety. Session 5: Encourage the resumption of intercourse very gradually. The presence of the partner will be advised. Session 6: measure of the evolution of the representations and knowledge of the patient. The skills of the patient will be evaluated from problem situations, motivation scale. The know-how will be evaluated using observation grid.
OTHERCollection of data concerning their sexuality
Patients in the control group are offered to participate in the study, which consists of collecting data on their sexuality. This in addition to the current care by the teams of care about erectile rehabilitation (information and medication prescriptions).
OTHERParticipation
Participation in a therapeutic education day.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot: * Aged over 18 * presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips. * affiliated to a social security scheme. * and having been informed and given informed consent to participation in the program.
Exclusion criteria
* Refusal of participation, signature of consent, * protected major patients, under guardianship or curators. * Patients unable to understand the course of the study * Patient with a documented history of cognitive or psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change the quality of sexual life of patients treated with radical prostatectomy (PR) | 18 months | Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General quality of life | Month 1, 6, 12 and 18 | Signing of questionnaire EuroQol-D5 (EQ-D5) |
| Sexual quality of life of the partner | Month 1, 6, 12 and 18 | Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner. |
| Number of erections obtained in the last month | Month 1, 6, 12 and 18 | Patient questionnaire to be filled every month at home by the patient and the partner |
| Number of reports deemed satisfactory | Month 1, 6, 12 and 18 | Patient questionnaire to be filled every month at home by the patient and the partner |
| Number of intracavernous injections performed per week | Month18 | Patient questionnaire to be filled every month at home by the patient and the partner |
| Patient Activation Measure (questionnaire PAM) | Month18 | — |
| Sexual function | Month 1, 6, 12 and 18 | Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component. |
| Continence: urinary handicap measurement scale (MHU) | Month 1, 6, 12 and 18 | — |
| Penis size (cm) | Month 1, 6, 12 and 18 | — |
| Knowledge acquisition measured by quizz build for the study made of simulated cases | Month 1, 6, 12 and 18 | — |
| acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases | Month 1, 6, 12 and 18 | — |
| Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale | Month 6 and18 | — |
| Depression level measured by the Hospital Anxiety and Depression (HAD) scale | Month 6 and18 | — |
| Erection Hardness Score (EHS) | Month 1, 6, 12 and 18 | — |
Countries
France
Contacts
Primary ContactDamien CARNICELLI, MD
Outcome results
None listed