(547) Erectile Dysfunction Following Radical Prostatectomy: An Overview, Critique, and Guidance on Future Directions (2023)

Abstract Introduction Despite modern surgical advancements and nerve-sparing techniques, men continue to endure delayed and incomplete erection recovery after radical prostatectomy (RP). Erectile rehabilitation has been described as an approach to promote erection recovery, but thus far studies on the most beneficial approach have been indeterminate. Objective This study serves to test the hypothesis that clinical trials that are meeting appropriate rigor in advancing the management of erectile dysfunction following radical prostatectomy. Methods We searched the clinicaltrials.gov website using the keywords “Erectile Dysfunction Radical Prostatectomy”. We included all resulting clinical trials with a time span ranging from 2005-2022. The specific parameters were interrogated to include disease state definitions, demographics, study design, assessment methodology, outcome measures, and data analysis. Results 46 trials were identified. 34 were Randomized Control Clinical Trials, 7 were Single Group Clinical Trials, and 5 were Observational Trials. 18 of the trials are complete, 7 ended before completion, and 21 are in progress. The trials included interventions ranging from mechanical devices (n=11), medical therapies (n=9), regenerative therapies (n=3), biological therapies (n=4), surgical interventions (n=12), and psychosocial interventions (n=2); validation of diagnostic questionnaires (n=3); and safety studies (n=2). Amongst the 18 completed studies, rigorous methods and randomization was applied. Observations included: short-term (6-12 month) erectile function measured by IIEF scores, lack of long-term follow up after treatment, and relative lack of trials focusing on erection recovery (n=2). Confounding variables were either exclusion criteria or matched appropriately. Study groups were primarily men aged 40-70 with localized prostate cancer who had normal sexual potency measured by IIEF scores prior to RP. Definitions such as erection recovery and erectile rehabilitation used in study introductions and titles are not always consistent with the primary outcomes measured. The vast majority of patients had well-defined pre-operative functional statuses. The surgical approaches are stated and well-defined. Compared to placebo at postoperative follow-up: Biologic therapies have been shown to improve IIEF scores up to 18 months but not to statistical significance; Shockwave therapy has not been shown to improve IIEF scores at 6 months; medical therapy with PDE-5i has shown to improve IIEF scores at 3, 6, and 12 months; regenerative therapy has shown improvements in IIEF scores at 6 months but not to statistical significance; medical devices have been shown to improve IIEF scores up to 12 months; psychosocial treatments have not demonstrated improvements in IIEF scores up to 12 months; intraoperative techniques have not been demonstrated to show a difference in IIEF scores up to 12 months. Conclusions This study shows that clinical trials have a potential to advance erectile function outcomes in men after RP. Trials that are randomized, controlled, representative of diverse populations, and characterized by well-defined terms, outcomes, and baseline functional status will be most useful in assessing the benefit of a treatment. Surgical interventions, medical therapies, and mechanical devices have been the primary interventions of focus, but other treatment options continue to show promising results. Nonetheless, more studies are needed with a long-term follow up to inform erection recovery and erectile rehabilitation protocols. Disclosure No