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

March 15, 2026 updated by: Cagri DOGAN, Namik Kemal University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Peyronie's disease is a fibrotic disorder of the tunica albuginea characterized by the formation of inelastic plaques within the penile shaft. These plaques may lead to penile curvature, indentation deformities, hinge effect, penile shortening, and difficulties during sexual intercourse. In patients with severe deformity or functional impairment, surgical correction remains the most effective treatment option. Plaque incision and grafting has traditionally been considered the standard surgical technique for complex Peyronie's disease, particularly in patients with severe curvature, multiplanar deformities, hourglass narrowing, or hinge effect. However, this approach requires tunical incision and graft placement, which may potentially increase the risk of postoperative erectile dysfunction, sensory changes, or graft-related complications.

Subtunical microdissection has recently been proposed as an alternative surgical approach aimed at reducing structural disruption of the tunica albuginea. In this technique, the plaque is approached through careful dissection beneath the tunical layer in order to release the deforming forces responsible for penile curvature while preserving the structural integrity of the tunica albuginea. The procedure is performed under approximately 3.5× optical magnification using surgical loupes, and the subtunical plane is meticulously dissected using microsurgical instruments. This technique allows controlled separation of fibrotic tissue from surrounding tunical structures with the aim of minimizing extensive tunical incision and reducing surgical trauma.

Despite the theoretical advantages of this technique, the clinical outcomes of subtunical microdissection have not yet been systematically compared with those of classical plaque incision and grafting in patients with complex Peyronie's disease.

The aim of this study is to compare the anatomical and functional outcomes of subtunical microdissection and classical plaque incision and grafting in patients with complex Peyronie's disease. Complex Peyronie's disease will include patients presenting with severe penile curvature, multiplanar deformity, hinge effect, hourglass deformity, or large plaques causing significant functional impairment.

In both surgical approaches, plaque incision and grafting is performed using the same graft material in order to standardize the procedure and minimize confounding variables. A bovine pericardium graft is used in all cases. In the classical technique, plaque incision is performed followed by graft placement. In the subtunical microdissection technique, plaque release is achieved through controlled subtunical dissection performed under approximately 3.5× optical magnification with microsurgical instruments. After adequate straightening is achieved, graft reconstruction is performed using the same bovine pericardial graft material.

The graft dimensions are calculated according to the geometric principles described by Egydio in order to achieve adequate defect coverage and penile straightening. All surgical procedures are performed by the same surgical team using a standardized operative technique. A uniform anesthesia protocol is also applied to all participants in order to minimize variability related to perioperative management.

Participants who meet the eligibility criteria and require surgical correction will undergo either subtunical microdissection or classical plaque incision and grafting according to the surgical approach selected by the treating surgeon. Patients will be followed prospectively after surgery to evaluate penile straightening, erectile function, and patient-reported outcomes.

The primary outcome of the study will be successful penile straightening, defined as a postoperative residual curvature of less than 30 degrees. Secondary outcomes will include changes in erectile function, patient satisfaction, penile length changes, perioperative complications, and the need for additional corrective procedures.

By comparing these two surgical approaches, this study aims to determine whether subtunical microdissection can provide effective curvature correction while potentially preserving erectile function and reducing surgical morbidity. The findings of this study may contribute to improving surgical decision-making and optimizing treatment strategies for patients with complex Peyronie's disease.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Tekirdağ
      • Tekirdağ, Tekirdağ, Turkey (Türkiye), 59100
        • Recruiting
        • Tekirdag Namik Kemal University Faculty of Medicine Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Erectile Function
Time Frame: 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.
Baseline and 6 months after surgery
Successful Penile Straightening
Time Frame: 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.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erection Hardness Score
Time Frame: Baseline and 6 months after surgery

Change in erection hardness assessed using the Erection Hardness Score (EHS).

The secondary outcome of this study is erection rigidity assessed using the Erection Hardness Score (EHS). The EHS is a validated clinical scale ranging from 1 to 4, where higher scores indicate greater erection hardness. Changes in erection hardness will be evaluated by comparing baseline values with
Baseline and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peyronie Disease

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to protect participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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