Peyronie Disease Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• \- 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

Locations
Other Locations
Turkey
Tekirdag Namik Kemal University Faculty of Medicine Hospital
RECRUITING
Tekirdağ
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Experimental: Subtunical Microdissection and Grafting
Participants with complex Peyronie's disease undergo subtunical microdissection and grafting. The procedure is performed under approximately 3.5× optical magnification using surgical loupes. The subtunical plane beneath the Peyronie's plaque is carefully dissected using microsurgical instruments to release deforming forces while preserving tunical integrity.
Active_comparator: Classic Plaque Incision and Grafting
Participants with complex Peyronie's disease undergo classical plaque incision and grafting surgery. The Peyronie's plaque is incised, and the tunical defect is repaired using graft material to correct penile curvature.
Related Therapeutic Areas
Sponsors
Leads: Namik Kemal University

This content was sourced from clinicaltrials.gov