PEnile ReHAbilitation (PEHAB) After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicenter, Randomized Clinical Trial

Prostate cancer

To evaluate the rates of return to adequate spontaneous unassisted erections at 24 months after nerve-sparing radical prostatectomy (nsRP) following a 12-month program of either daily sildenafil (75/100mg) and vacuum erection device (VED) therapy five times a week or Sildenafil(75/100mg) on-demand (≤3 times a week).

Erectile function endpoints:  The return to baseline erection rate 24 months after nsRP according to the IIEF-EF or EPIC-erection function and EHS, comparing two different penile rehabilitation programmes., Erectile function endpoints:  The time to recovery of erectile function using IIEF-EF or EPIC-erection function and EHS, comparing two different penile rehabilitation programmes., Erectile function endpoints:  The rates of achieving good unassisted erections at 18 months according to IIEF-EF or EPIC-erection function and EHS, comparing two different penile rehabilitation programmes., Erectile function endpoints:  The rate of patients achieving good assisted erections at 6, 9, 12, and 18 months according to IIEF-EF or EPIC-erection function and EHS, comparing two different penile rehabilitation programs. The stretched penile length at 12 months compared to baseline., Health related and sexual quality of life endpoints:  Other sexual function scores (i.e. orgasmic function), feelings of masculinity and health-related quality of life scores between the treatment groups and between hetero versus gay/bisexual patients over time. Using IIEF-15 domains, EPIC-sexual domain, QLQC30, PRP-25 and two self-composed masculinity and gay/bisexual inventory at baseline, 12 months and 24 months., Health related and sexual quality of life endpoints:  The effects of climacturia between the groups. Using a self- designed questionnaire based on validated questionnaires. Measurements will take place 12 months and 24 months after surgery., Health related and sexual quality of life endpoints:  The partner interaction between the treatment groups. Using a self-designed questionnaire based on validated questionnaires. At baseline, 12 months and 24 months., Adherence and side effects endpoints:  The adherence to the penile rehabilitation programs during the first 12 months of follow-up. Taking into account noted side effects and frequency of use of the prescribed treatment strategies. Using a self-de- signed questionnaire based on validated questionnaires., Best tool to evaluate erectile function endpoint:  The pre-operative IIEF-EF and EPIC-sexual domain scores between patients who are engaged in sexual intercourse and those who are not., Partner endpoints:  Satisfaction with rehabilitation program from partners’ perspective at 12 months and 24 months.  The partner interaction between the treatment groups from partners’ perspective. Using a self-designed questionnaire based on validated questionnaires at baseline and 24 months after surgery.  Sexual health related quality of life scores of partners between the different treatment groups. Using EORTC QLQ-SH22 at baseline at 12 months and 24 months after surgery.

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