Sexual Rehabilitation After Nerve-Sparing Radical Prostatectomy: Free-of-Charge Phosphodiesterase Type 5 Inhibitor Administration Improves Compliance to Treatment
Authors: Siena Giampaolo , Mari Andrea , Canale Aude , Mondaini Nicola , Chindemi Andrea , Greco Isabella , Saleh Omar , Serni Sergio , Nicita Giulio , Minervini Andrea , Carini Marco 
Published: February 2018

Abstract

Background
In December 2006, the region of Tuscany (Italy) authorized the free-of-charge provision of phosphodiesterase type 5 inhibitors (PDE5I) for all patients with Tuscan citizenship who undergo nerve-sparing radical prostatectomy (NSRP).

Objective
To compare sexual rehabilitation outcomes in patients with low risk of erectile dysfunction and minimal comorbidities who received PDE5Is free of charge (PDE5I-F) with those who paid for PDE5Is (PDE5I-P) after bilateral NSRP.

Methods
We reviewed prospectively recorded clinical data of 2,368 patients with Tuscan (PDE5I-F) and non-Tuscan (PDE5I-P) citizenship treated with NSRP at 3 different institutions in Tuscany from 2008 to 2013. Inclusion criteria for the final analysis were open or robot-assisted bilateral NSRP; low risk of postoperative erectile dysfunction according to the Briganti risk stratification tool; no smoking and no drug and alcohol abuse; no cardiovascular risk factors; no major surgery before and after NSRP; no neoadjuvant or adjuvant treatment; and no biochemical relapse. Dropout was defined as an interruption longer than 40 days of the treatment protocol indicated in the inclusion criteria. Treatment compliance was defined as more than 90% consumption of the prescribed PDE5I.

Outcomes
The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the Italian version of the University of California–Los Angeles Prostate Cancer Index sexual function (UCLA-PCI-s) questionnaires were administered to assess patients' satisfaction with PDE5I treatment and sexual function.

Results
Overall, 648 patients in the PDE5I-F group and 182 in the PDE5I-P group met the inclusion criteria and were eligible for the study. Patients had comparable preoperative and surgical characteristics. The PDE5I-F group had a significantly higher early rehabilitation onset (P &lt; .001), lower treatment dropout at 12, 24, and 36 months (P &lt; .001 for all comparisons), and higher compliance to the treatment protocol at 6 and 12 months (P = .01 and P &lt; .001, respectively). At multivariable analysis, the PDE5I-F protocol was an independent predictor of an EDITS score higher than 50 (hazard ratio = 1.54, P = .03) and a UCLA-PCI-s score higher than 50 (hazard ratio = 3.12, P = .01) after adjusting for the effects of several clinical features.

Clinical Implications
The free-of-charge protocol has a significant impact on patients' satisfaction with PDE5I treatment.

Strengths and Limitations
To our knowledge, this is the first study comparing free vs paid access to a sexual rehabilitation protocol. Major limitations are the observational nature of the study and the different population sizes of the 2 groups.

Conclusions
In a selected cohort of patients after NSRP, free-of-charge access to a sexual rehabilitation protocol was significantly associated with higher early rehabilitation onset, major compliance to the protocol, minor treatment dropout, and higher satisfaction rate of patients.