Efficacy and safety of hyaluronic acid and enzymatic mix intralesional therapy in Peyronie's disease: a prospective, randomized, controlled pilot study of outcomes and patient satisfaction
Abstract
Introduction: Peyronie's disease (PD) is characterized by fibrotic plaque formation leading to penile curvature. Xiapex's 2020 withdrawal from Europe eliminated validated intralesional therapies. This study evaluated the efficacy and safety of an intralesional hyaluronic acid-enzymatic mix (Fibrorestil: 0.05% sodium hyaluronate + recombinant collagenase/lyase/lipase) added to daily tadalafil and penile traction versus conservative therapy alone in men with stable-phase PD.
Methods: This prospective, randomized, open-label, multicenter pilot trial (June 2023-March 2025; ClinicalTrials.gov NCT07341529; HUPHM-85-21) enrolled 38 men with stable PD, palpable plaque, and 30°-90° curvature. Group A received three intralesional sessions with plaque tunneling plus Andropenis extender (≥4 hours/day) and tadalafil (2.5-5 mg/day). Group B received traction and tadalafil (conservative therapy) alone. Assessments were performed at baseline and week 28. Analyses used intention-to-treat (n = 38) and per-protocol (n = 34) approaches, with Mann-Whitney U tests. Primary outcomes were absolute and relative curvature change (responders ≥15° improvement). Secondary outcomes included Peyronie's Disease Questionnaire (PDQ) changes; IIEF-EF minimal clinically important difference; satisfaction; and Clavien-Dindo adverse events.
Results: Baseline curvatures was higher in Group A (60° [50;70] vs 45° [30;60], P = .037) with Group B showing more diabetes, numerically more hourglass deformity and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 38 participants or records.
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