Francis Petrella et al., 2024: Study Protocol for a Randomized Controlled Trial of Low Intensity Shockwave Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction: "SHARP-ED TRIAL"
Francis Petrella, Braian R Ledesma, David Velasquez, Manuel Molina, Russell G Saltzman, Sanoj Punnen, Paul H Chung, Ranjith Ramasamy
Desai Sethi Urology Institute, Miller School of Medicine, University of Miami, Miami, Florida, USA.
Department of Urology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Abstract
Introduction: Erectile Dysfunction (ED) is a common challenge post Radical Prostatectomy (RALP), affecting men's sexual health after undergoing definitive cancer therapy. Despite employing nerve-sparing techniques, ED remains a prevalent issue in this population. Studies indicate that approximately 70%-85% of men experience varying degrees of ED following RALP. The existing treatment landscape for post-RALP-ED presents limitations, and a discernible knowledge gap persists. To address this, our study aims to investigate the efficacy of Shockwave Therapy (SWT) as a potential intervention for managing ED after RALP.
Methods: This prospective, randomized, sham-controlled clinical trial aims to recruit 189 eligible patients post-RP and assess the effects of SWT. Comprehensive screening, including medical history, physical examinations, and biochemical evaluations, will be conducted to confirm eligibility. The intervention involves utilizing a device to administer focal shockwaves targeted at cavernosal tissue. Safety measures include continuous monitoring for adverse events and rigorous reporting protocols. The primary endpoint assesses changes in participants' ability to engage in penetrative intercourse from baseline to study completion, while secondary endpoints encompass various measures of erectile function, including questionnaire-based assessments, ultrasound parameters, and clinical outcomes.
Results: Statistical analysis, encompassing ANOVA for continuous variables and Fisher's exact test for categorical ones, will evaluate demographic characteristics, baseline data, and primary as well as secondary outcomes for statistical significance. Detailed analysis of trends, subgroup comparisons, and treatment effects will provide a comprehensive understanding of the impact of SWT on post-RP ED.
Conclusion: This study protocol represents a rigorous investigation into the potential therapeutic role of SWT in managing post-RP ED. The outcomes from this study aim to contribute valuable insights into the efficacy, safety, and potential improvements in erectile function following SWT, providing significant guidance for future interventions aimed at addressing this challenging condition affecting men's health and quality of life.
J Clin Trials. 2024;14(3):559. Epub 2024 Apr 8. PMID: 38911594 PMCID: PMC11192546
Comments 1
This a summary of the study protocol for the "SHARP-ED TRIAL":
The "SHARP-ED TRIAL" is a randomized controlled trial that investigates the effectiveness of Low Intensity Shockwave Therapy (Li-ESWT) for treating erectile dysfunction (ED) after radical prostatectomy (RP). Radical prostatectomy, a common treatment for localized prostate cancer (PCa), often results in ED due to damage to the cavernous nerves (CN). This trial aims to address this issue by evaluating whether shockwave therapy can aid in nerve regeneration and improve erectile function.
Background of the study
Prostate Cancer and Radical Prostatectomy: Each year, about 250,000 new cases of prostate cancer are diagnosed in the U.S. Radical prostatectomy is a widely used surgical treatment for localized prostate cancer, which can lead to erectile dysfunction due to nerve damage.
Erectile Dysfunction Post-RP: Despite nerve-sparing surgical techniques, up to 80% of men experience some degree of ED after surgery. This ED can persist for years and is linked to decreased oxygenation and structural changes in penile tissue.
Existing Treatments: Current treatments, such as PDE5 inhibitors, often fail due to iatrogenic damage to the cavernous nerves. Penile rehabilitation strategies are used but have limited effectiveness.
Objectives of the study
The primary objective is to assess the safety and effectiveness of Li-ESWT in improving erectile function shortly after radical prostatectomy. The therapy is hypothesized to enhance angiogenesis and neurogenesis, potentially reversing ED by stimulating the regeneration of nerve and blood vessel tissue.
Methodology of the study
The study is a prospective, randomized, sham-controlled clinical trial.189 men, aged 40-75, who have undergone radical prostatectomy will be enrolled. They will be randomized into two groups (2:1 ratio) receiving either active treatment or sham therapy.Li-ESWT will be administered using the MoreNova device, focusing on the corpora cavernosa and crura. The therapy will commence six weeks post-surgery and continue for six months, followed by a six-month follow-up.
Primary Endpoint: The main outcome is the improvement in the ability to engage in penetrative intercourse without invasive treatments, as measured by the International Index of Erectile Function (IIEF-EF) questionnaire.
Safety and Monitoring
Participants will undergo comprehensive medical evaluations, including physical exams and blood tests. Adverse events will be monitored throughout the study, with continuous data review by a research committee. The trial aims to provide robust data on the efficacy of Li-ESWT for post-RP ED. If successful, this therapy could offer a non-invasive treatment option, improving the quality of life for many men affected by this condition.
Conclusion
The SHARP-ED TRIAL seeks to establish Li-ESWT as a viable therapeutic approach for erectile dysfunction following radical prostatectomy. By addressing a significant unmet need, the study could pave the way for new treatment standards in managing post-surgical ED.
Indeed, the design of this study will allow to provide important information of the value of Li-ESWT in the management of erectile dysfunction following RALP.
Jens Rassweiler