Lucio Dell'Atti et al., 2024: Vacuum Erection Device Plus Once-Daily Tadalafil Improve Clinical Outcomes after Extracorporeal Shock Wave Therapy in Men Affected by Erectile Dysfunction Associated with Peyronie's Disease
Lucio Dell'Atti 1, Viktoria Slyusar 2, Piero Ronchi 1, Chiara Cambise 3
1Department of Urology, University-Hospital of Marche, 60126 Ancona, Italy.
2Pain Therapy Center, Division of Anesthesia and Intensive Care, University-Hospital of Marche, 60126 Ancona, Italy.
3Department of Emergency, University-Hospital Gemelli IRCSS, 00168 Roma, Italy
Abstract
Background: The purpose of this study is to examine the combination of the mechanical effects of penile therapy with vacuum erection devices (VEDs) plus PDE5i, which improve clinical outcomes after extracorporeal shockwave therapy (ESWT) in men affected by erectile dysfunction (ED) associated with Peyronie's disease (PD).
Methods: A total of 153 medical records of patients affected by PD in stable stage with ED and treated with ESWT were divided into two groups. Group A (GA) included 72 men treated with ESWT, mechanical stretching with VEDs and PDE5ì (Tadalafil 5 mg), and Group B (GB) included 81 men who received only ESWT plus Tadalafil 5 mg with the same protocol of GA. The patients in both groups were assessed at baseline and follow-up for erectile function, painful erections, penile plaque size, and penile curvature. The results were evaluated at baseline and 3, 6, and 12 months after the treatments.
Results: Three months after the treatment, GA patients had a reduction in penile curvature degree from a mean ± SD of 33.91 ± 8.34° at baseline to a mean ± SD of 19.46 ± 7.15° after 12 months, whereas pain in an erection or during intercourse was resolved completely in 88.9% of the patients. The mean ± SD IIEF-15 score of patients affected by severe/moderate ED further improved significantly in the GA group (p < 0.001) after 3, 6, and 12 months of treatment. There were no permanent adverse sequelae after treatments.
Conclusions: The regular use of a VED plus Tadalafil in patients who had undergone ESWT significantly provided more benefit in patients with PD in terms of penile deformity, pain, and erectile function.
Life (Basel). 2024 Sep 13;14(9):1162. doi: 10.3390/life14091162. PMID: 39337945
PMCID: PMC11432888
Comments 1
Introduction
Peyronie’s Disease (PD) is a condition characterized by the fibrotic degeneration of penile tissue, leading to curvature and erectile dysfunction (ED). It predominantly affects men over 40, with a prevalence of 0.4% to 7%. The management of PD, especially during its active phase, includes various conservative treatments like oral medications, injections, vacuum erection devices (VED), and extracorporeal shockwave therapy (ESWT). This study aims to investigate the combined effect of VED and Tadalafil (a phosphodiesterase type 5 inhibitor) on clinical outcomes in men with chronic PD and ED following ESWT.
Study Design and Methods
Participants: The study included 153 men diagnosed with PD and ED. Participants were categorized into two groups:
- Group A (GA): 72 patients received ESWT, VED, and Tadalafil (5 mg daily).
- Group B (GB): 81 patients received ESWT and Tadalafil only.
Inclusion Criteria: Patients aged more then18 years with PD lasting for more then12 months, presence of only one stable penile plaque less 20 mm in largest diameter and no prior medical treatment for 3 months, and ED.
Treatment Protocol: Patients underwent ESWT using a Duolith SD1 T-TOP URO (Storz Medical AG®, Tägerwilen, Switzerland) device for the treatment of patients by two expert urologists. Patients received 3000 shockwaves per session over six weeks at a level of energy from 0.15 mJ/mm2 to 0.30 mJ/mm2 and a frequency of 6–8 Hz. Group A utilized the VED for 10 minutes twice daily for 3 months, while Group B used Tadalafil only.
Outcome Measures: The effectiveness of treatments was assessed based on penile curvature, erectile function (using the IIEF-15 score), and pain during erections (using the VAS scale) at baseline and at 3, 6, and 12 months post-treatment.
Results
Penile Curvature Outcomes: After one year (14.6 months), Group A showed a significant reduction in penile curvature from a mean of 33.91° to 19.46° and improved erectile function in 88.9% of patients. Group B had a decrease in curvature from 32.64° to 24.10°, with improved sexual function in 60.5% of men. Both reductions were statistically significant (p less 0.001).
Erectile Function Improvement
- International Index of Erectile Function (IIEF-15) Scores: Group A showed a significant improvement in IIEF scores at 3, 6, and 12 months post-treatment (p less 0.001).The percentage of patients achieving improved sexual function: Group A: 88.9% (64 out of 72) versus Group B: 60.5% (49 out of 81).
Pain Assessment:
- Visual Analog Scale (VAS): Pain during erections decreased significantly in both groups, with GA showing a greater reduction over time.
Adverse Events
- Minimal adverse effects were noted. Superficial hematomas occurred in both groups but did not lead to significant complications. No severe interventions were required for adverse events.
Discussion
The study's findings underscore the beneficial effects of combining a Vacuum Erection Device (VED) with Tadalafil in improving clinical outcomes for men suffering from Peyronie’s Disease (PD) and erectile dysfunction (ED) after undergoing extracorporeal shock wave therapy (ESWT). This is a retrospective trial that shows significant improvement of curvature and ED in both groups
Mechanistic Insights: The study suggests that VED may help re-organize the extracellular collagen matrix in the penis, which is crucial for addressing the fibrotic plaques characteristic of PD. This mechanical stretching may also promote tissue remodeling, potentially reversing some of the damage caused by the disease.
Impact on Erectile Dysfunction: The article highlights that ED prevalence in PD patients ranges from 40% to 60%. The psychological and physical ramifications of both conditions can significantly affect the quality of life. The combined use of VED and Tadalafil not only addresses the physical deformities but also alleviates psychological distress associated with sexual dysfunction.
Role of Tadalafil: There are two mechanisms of action: (i) Tadalafil operates by inhibiting phosphodiesterase type 5 (PDE5), enhancing the effects of nitric oxide and increasing blood flow to the penis. This pharmacological approach is effective in managing ED, especially when combined with mechanical therapies like VED; (ii) however Taldalafil has also an impact on the collagenase synthesis and improves pain due to PD as well as inhibits the promotion of the disease.
Study Design Limitations: The study was non-randomized and retrospective, which could introduce biases, such as patient selection and treatment adherence. For instance, patients who opted for the vacuum device may have been more motivated or financially capable, potentially.
Jens Rassweiler