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

Condition(s) studied

Investigational drug(s) / intervention(s)

Subtunical microdissection and grafting: Both surgical approaches are performed in patients with complex Peyronie's disease using the same graft material and standardized defect calculation based on geometric principles. In the classical technique, plaque incision is performed followed by graft reconstruction of the tunical defect. In the subtunical microdissection technique, the plaque is approached through careful dissection of the subtunical plane under approximately 3.5× optical magnification using microsurgical instruments in order to release deforming forces while preserving the erectile tissue.

Classic plaque Incision and Grafting: Classical plaque incision and grafting performed in patients with complex Peyronie's disease. After plaque incision, the tunical defect is reconstructed using the same graft material. Defect size is calculated according to standard geometric principles in order to achieve penile straightening.

Study 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

Primary outcome measure(s)

• Change in Erectile Function — Baseline and 6 months after surgery
  Change in erectile function measured using the International Index of Erectile Function (IIEF-5).The primary outcome of this study is the change in erectile function after Peyronie's disease surgery. The primary outcome of this study is the change in erectile function after Peyronie's disease surgery. Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. The IIEF-5 score ranges from 5 to 25, with higher scores indicating better erectile function. Changes in erectile function will be evaluated by comparing baseline scores with those obtained 6 months after surgery.
• Successful Penile Straightening — 6 months after surgery
  residual curvature \<30° Penile curvature will be assessed in a standardized manner. The degree of curvature will be measured from photographs obtained during erection induced by intracavernosal injection. The angle of curvature will be calculated using digital angle measurement on standardized photographs. The same measurement method will be used at baseline and during postoperative follow-up. To improve consistency and reduce measurement bias, curvature assessment will be performed by an investigator experienced in Peyronie's disease evaluation.

Trial sites (1)

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