NCT07470528 Comparative Outcomes of Subtunical Microdissection and Grafting Versus Classical Plaque Incision and Grafting in Complex Peyronie's Disease

Eligibility & Interventions

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This trial targets 80 participants in total. It began in 2025-05-27 with a primary completion date of 2026-10.

Brief Summary

The goal of this clinical study is to compare two surgical techniques used for the treatment of complex Peyronie's disease. Peyronie's disease can cause penile curvature, deformity, and difficulties during sexual intercourse due to fibrotic plaques within the penile tunica albuginea. In patients with severe deformity, surgical correction is often required. The main question this study aims to answer is whether subtunical microdissection can provide effective correction of penile curvature while preserving erectile function when compared with the classical plaque incision and grafting technique. Participants with complex Peyronie's disease who require surgical correction will undergo either subtunical microdissection or classical plaque incision and grafting. In order to standardize the procedures, the same graft material will be used in both surgical techniques. A bovine pericardial graft will be applied in all cases, and graft size will be determined according to the geometric principles described by Egydio. In the subtunical microdissection technique, the subtunical plane beneath the Peyronie's plaque is carefully dissected using microsurgical instruments under approximately 3.5× optical magnification with surgical loupes. In the classical technique, plaque incision is performed followed by graft reconstruction of the tunical defect. All surgical procedures will be performed by the same surgical team using a standardized operative approach and a uniform anesthesia protocol. Participants will be followed prospectively after surgery to evaluate penile curvature, erectile function, and patient satisfaction. The results of this study may help determine whether subtunical microdissection represents an effective and safe alternative surgical strategy for the treatment of complex Peyronie's disease.

Eligibility Criteria

Inclusion Criteria: * \- Male patients aged 18 years or older * Diagnosis of Peyronie's disease with stable plaque and stable penile curvature for at least 3 months * Presence of complex Peyronie's disease including severe curvature, multiplanar deformity, hinge effect, hourglass deformity, or large plaques causing functional impairment * Patients requiring surgical correction with graft-based reconstruction * Ability to provide informed consent and comply with follow-up evaluations Exclusion Criteria: * Ossified Peyronie's plaques requiring plaque excision * Congenital penile curvature (congenital chordee) * Previous penile prosthesis implantation * Active phase Peyronie's disease with progressive curvature or penile pain * Severe erectile dysfunction not responsive to medical therapy * History of prior penile reconstructive surgery * Significant systemic illness preventing surgical treatment * Inability to complete postoperative follow-up assessments

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