The Role of PDE5 Inhibitors in Penile Septal Scar Remodeling: Assessment of Clinical and Radiological Outcomes

Abstract

Introduction Effective oral medication for use in men with Peyronie's disease (PD) has been an area of interest of the medical community and lay public for decades. Isolated septal scars (ISS) without evidence of penile deformity is a relatively new clinical entity, and at present, there is paucity in the published literature regarding its treatment. Current research into the use of phosphodiesterase type 5 (PDE5) inhibitors in regulating penile erectile response has revealed an alternative role for PDE5 inhibitors in decreasing oxidative stress-associated inflammatory change as seen in PD. Aim To examine the presence of ISS and assess the efficacy of PDE5 inhibitor use in septal scar remodeling. Methods Retrospective review of prospective database on all men who underwent penile Doppler ultrasound between December 2007 and December 2009. Main Outcome Measures Of the 65 men with ultrasonographic-confirmed ISS, 35 men received tadalafil 2.5 mg daily over a 6-month period. The clinical outcomes between the two groups were compared using International Index of Erectile Function (IIEF)-5 score and 6 months penile Doppler ultrasound follow up. Results The mean age for the tadalafil group was 43.2 (20–65) years, similar to the control group at 44.2 (34–72) years. The length of time from onset to presentation was 22 (6 to 40) months. The majority of ultrasonographic-proven ISS was not clinically palpable and complaint of decreased penile rigidity (66%) was the predominant feature. Treatment with low-dose daily tadalafil did not result in any significant side effects (such as headache and flushing) or discontinuation. The tadalafil group reported higher IIEF-5 score (pretreatment 11/25 to post-treatment 18/25) (P < 0.01) and resolution of septal scar were recorded in 24 patients (69%) compared to three patients (10%) in the control group. Conclusion Low-dose daily tadalafil is a safe and effective treatment option in septal scar remodeling.

Treatment of Peyronie’s Disease: 2012 Update

“…Phosphodiesterase type 5 (PDE5) inhibitors have been shown to decrease oxidative stress-associated inflammation in patients with PD [30]. Low-dose daily tadalafil treatment is reported successful with septal scar resolution, which suggests that PDE5 inhibitors may be beneficial in the management of PD.…”

2018 Canadian Urological Association guideline for Peyronie's disease and congenital penile curvature

“…1,3 The presence of multiple plaques on both sides of the penis, or plaques within the intracavernosal septum can result in penile shortening with or without deformity. 9,25 Patient self-reporting of curvature versus objective examination supports the clinical principal that prior to non-invasive or invasive treatments (intralesional injection therapy or surgery), and to monitor treatment effect, it is recommended to examine the erection to determine penile length, degree of curvature, hourglass deformities, and rigidity of erection. [1][2][3] Digital photographs at full erection are measured via protractor to determine angle(s) of uni-and multiplanar disease.…”

“…The use of PDE-5 inhibitors, specifically tadalafil 5 mg OD to modify Peyronie's plaque progression appears promising, but to date data is limited to a single published study. 25 Current medical literature is replete with several further agents proposed solely on their efficacy in animal models of PD, when in fact there is valid concern that such models are not representative of human PD. Use in a study setting with full patient consent or in special situations may be justified on an ad hoc basis, but clearly the evidence is simply not in place for general use.…”

The recent phosphodiesterase type 5 inhibitors

“…Out of 65 men with isolated septal scars, as confirmed by means of ultrasonographic examination, 35 received 2.5 mg tadalafil daily over a period of 6 months. In 24 patients (69%) who had been given the drug, a resolution of the septal scars was recorded, in comparison to three patients in the control group (30 patients) [40]. Clinical research on the role of PDE5 inhibitors in reversing/ remodelling fibrotic lesions/scars and decreasing inflammatory alterations associated with oxidative stress in penile septal and erectile tissue will remain an area of interest among the medical community until further prospective, double-blind, randomized, placebo-controlled trials are conducted.…”