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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients in the experimental group are offered to participate in a 6-session therapeutic education program on sexuality, ranging from 15 days before surgery to approximately 3 months after. This in addition to the current care by the teams of care about sexual rehabilitation (information and medication prescriptions). |
|
| Control group | Sham Comparator | Patient without therapeutic education. |
|
| Partner | Other | Patient's partner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change the quality of sexual life of patients treated with radical prostatectomy (PR) | Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component. | Month 1, 6, 12 and 18 |
| General quality of life | Signing of questionnaire EuroQol-D5 (EQ-D5) |
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Inclusion Criteria:
Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot:
Exclusion Criteria:
Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot Hospital for a Prostatectomy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damien CARNICELLI, MD | Contact | 04 72 67 88 01 | +33 | damien.carnicelli@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Etienne TERRIER, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Hédouard Herriot | Recruiting | Lyon | 69003 | France |
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| Collection of data concerning their sexuality | Other | 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). |
|
| Participation | Other | Participation in a therapeutic education day. |
|
| Month 1, 6, 12 and 18 |
| Sexual quality of life of the partner | Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner. | Month 1, 6, 12 and 18 |
| Number of erections obtained in the last month | Patient questionnaire to be filled every month at home by the patient and the partner | Month 1, 6, 12 and 18 |
| Number of reports deemed satisfactory | Patient questionnaire to be filled every month at home by the patient and the partner | Month 1, 6, 12 and 18 |
| Number of intracavernous injections performed per week | Patient questionnaire to be filled every month at home by the patient and the partner | Month18 |
| Patient Activation Measure (questionnaire PAM) | Month18 |
| Erection Hardness Score (EHS) | Month 1, 6, 12 and 18 |
| 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 |
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | France |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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