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

NCT07470528 | Recruiting

• 1 other identifier: Peyronie Disease
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie's Disease (PD)

Keywords

Peyronie's Disease; Complex Peyronie's Disease; Subtunical Microdissection; Plaque Incision and Grafting; Penile Reconstruction

Outcome Measures

Primary Outcomes (2)

• Change in Erectile Function

  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.

  Baseline and 6 months after surgery

• Successful Penile Straightening

  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.

  6 months after surgery

Secondary Outcomes (1)

• Erection Hardness Score

  Baseline and 6 months after surgery

Study Arms (2)

Subtunical Microdissection and Grafting

EXPERIMENTAL

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.

Procedure: Subtunical microdissection and grafting

Classic Plaque Incision and Grafting

ACTIVE COMPARATOR

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.

Procedure: Classic plaque Incision and Grafting

Interventions

Subtunical microdissection and grafting PROCEDURE

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.

Subtunical Microdissection and Grafting

Classic plaque Incision and Grafting PROCEDURE

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.

Classic Plaque Incision and Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namik Kemal University Faculty of Medicine Hospital

Tekirdağ, 59100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Roadman D, Wang V, Beer A, Levine L. A contemporary assessment of the evaluation and management of patients presenting to a tertiary medical center with Peyronie's disease. Int J Impot Res. 2024 Apr;36(2):118-124. doi: 10.1038/s41443-023-00738-w. Epub 2023 Jul 19.

  PMID: 37468535 BACKGROUND

• Kadioglu A, Gurcan M, Rakhmonovich AF, Dursun M. Surgical management of complex curvature in Peyronie's disease. World J Urol. 2024 Apr 30;42(1):276. doi: 10.1007/s00345-024-04936-z.

  PMID: 38689034 BACKGROUND

• Egydio PH, Lucon AM, Arap S. A single relaxing incision to correct different types of penile curvature: surgical technique based on geometrical principles. BJU Int. 2004 Nov;94(7):1147-57. doi: 10.1111/j.1464-410X.2004.05220.x. No abstract available.

  PMID: 15541152 BACKGROUND

MeSH Terms

Conditions

Penile Induration

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Number of Participants: 80 Type: Anticipated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Model Details: Participants with complex Peyronie's disease will undergo either subtunical microdissection and grafting or classical plaque incision and grafting. Outcomes between the two surgical approaches will be compared prospectively.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: May 27, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)