A Retrospective Study of Erectile Function and Use of Erectile Aids in Prostate Cancer Patients After Radical Prostatectomy in Denmark

Introduction: Radical prostatectomy (RP) offers a good long-term cancer control for clinically localized prostate cancer. However, complications such as erectile dysfunction and substantial decreases quality of life of the afflicted men and their sexual partners. Identification of pre-, per-, and postoperative factors that correlate with poor postoperative erectile status must be considered an important step to improving penile rehabilitation. Aim: To describe postoperative erectile function after RP in a Danish cohort. Methods: The medical records of 1,127 patients undergoing RP from March 2003 through September 2014 were reviewed retrospectively with a 12-month follow-up after surgery. In all, 704 patients fulfilling the inclusion criteria were included in the final analysis. Recovery was defined as self-reported erection sufficient for intercourse (ESI) with or without usage of erectile aids. Main Outcome Measures: Subjective reporting of erectile function and usage erectile aids 12 months after RP. Results: ESI with or without erectile aids was reported by 226 men (32.1%), among whom 109 (48.2%) required erectile aids. Erectile dysfunction (ED) was reported by 478 men (67.9%) and by 121 (25.3%) despite use of erectile aids. Of men with ED, 155 (22%) stated not being interested in penile rehabilitation, 26 (3.7%) stated not having resumed their sex life 12 months after RP, and 241 (34.2%) had ED and were unsatisfied with the condition. We found that 134 of 445 men (30.1%) who underwent non–nerve-sparing RP had ESI 12 months after RP. Age older than 60.5 years, a high body mass index, comorbidity, and a high American Society of Anesthesiologists score were negative predictors of erectile function 12 months after RP. Conclusion: Twelve months after RP, 32.1% of men had ESI; half these men required the use of erectile aids. Age older than 60.5 years, a high body mass index, comorbidity, and a high American Society of Anesthesiologists score were negative predictors for ED 12 months after RP. Haahr MK, Azawi NH, Andersen LG, et al. A Retrospective Study of Erectile Function and Use of Erectile Aids in Prostate Cancer Patients After Radical Prostatectomy in Denmark. Sex Med 2017;5:e156–e162

Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial

Background: Prostate cancer is the most common cancer in men, and radical prostatectomy (RP) often results in erectile dysfunction (ED) and a substantially reduced quality of life. The efficacy of current interventions, principal treatment with PDE-5 inhibitors, is not satisfactory and this condition presents an unmet medical need. Preclinical studies using adipose-derived stem cells to treat ED have shown promising results. Herein, we report the results of a human phase 1 trial with autologous adipose-derived regenerative cells (ADRCs) freshly isolated after a liposuction. Methods: Seventeen men suffering from post RP ED, with no recovery using conventional therapy, were enrolled in a prospective phase 1 open-label and single-arm study. All subjects had RP performed 5–18 months before enrolment, and were followed for 6 months after intracavernosal transplantation. ADRCs were analyzed for the presence of stem cell surface markers, viability and ability to differentiate. Primary endpoint was the safety and tolerance of the cell therapy while the secondary outcome was improvement of erectile function. Any adverse events were reported and erectile function was assessed by IIEF-5 scores. The study is registered with ClinicalTrials.gov, NCT02240823. Findings: Intracavernous injection of ADRCs was well-tolerated and only minor events related to the liposuction and cell injections were reported at the one-month evaluation, but none at later time points. Overall during the study period, 8 of 17 men recovered their erectile function and were able to accomplish sexual intercourse. Post-hoc stratification according to urinary continence status was performed. Accordingly, for continent men (median IIEFinclusion = 7 (95% CI 5–12), 8 out of 11 men recovered erectile function (IIEF6months = 17 (6–23)), corresponding to a mean difference of 0.57 (0.38–0.85; p = 0.0069), versus inclusion. In contrast, incontinent men did not regain erectile function (median IIEF1/3/6 months = 5 (95% CI 5–6); mean difference 1 (95% CI 0.85–1.18), p > 0.9999). Interpretation: In this phase I trial a single intracavernosal injection of freshly isolated autologous ADRCs was a safe procedure. A potential efficacy is suggested by a significant improvement in IIEF-5 scores and erectile function. We suggest that ADRCs represent a promising interventional therapy of ED following prostatectomy. Funding: Danish Medical Research Council, Odense University Hospital and the Danish Cancer Society