Subtunical microdissection and grafting versus classical plaque incision and grafting for complex Peyronie's disease
Comparative Outcomes of Subtunical Microdissection and Grafting Versus Classical Plaque Incision and Grafting in Complex Peyronie's Disease
This test will see if subtunical microdissection with a bovine pericardial graft corrects severe penile curvature while better preserving erectile function than classic plaque incision and grafting in men with complex Peyronie's disease who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Namik Kemal University Academic / other |
| Locations | 1 site (Tekirdağ, Tekirdağ) |
| Trial ID | NCT07470528 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two graft-based surgical techniques for complex Peyronie's disease at a single center in Tekirdag, Turkey. Eligible men with stable, complex deformities will undergo either subtunical microdissection with grafting or classical plaque incision and grafting, with the same bovine pericardial graft material and graft sizing determined by geometric principles. The subtunical microdissection technique uses microsurgical dissection beneath the tunica under magnification to release plaque-related deformity while aiming to preserve tunical integrity. Outcomes will focus on correction of curvature and preservation of erectile function, along with graft- and surgery-related complications during postoperative follow-up.
Who should consider this trial
Good fit: Men aged 18 or older with stable, complex Peyronie's disease (severe or multiplanar curvature, hourglass or hinge deformity) who require graft-based surgical reconstruction and can complete follow-up are ideal candidates.
Not a fit: Patients with ossified plaques needing excision, congenital curvature, active/progressive disease, prior penile prosthesis or reconstructive surgery, severe unresponsive erectile dysfunction, or serious systemic illness are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the subtunical microdissection approach could correct deformity while reducing the risk of postoperative erectile dysfunction and graft-related complications.
How similar studies have performed: Classical plaque incision and grafting is an established standard for complex cases, while subtunical microdissection is a newer technique with limited published data and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tekirdağ, Tekirdağ
- Tekirdag Namik Kemal University Faculty of Medicine Hospital — Tekirdağ, Tekirdağ, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.