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

Recruiting now · Not applicable

Conditions studied: Peyronie's Disease (PD)

In brief

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.

Key facts

Study ID

NCT07470528

Run by

Namik Kemal University

People needed

80

Starts

2025-05-27

Expected to finish

2026-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• - 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

You may not qualify if…

• 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

Where it is running

• Tekirdag Namik Kemal University Faculty of Medicine Hospital — Tekirdağ, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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