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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 orde
• Процедура 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.

Первичные конечные точки

• Change in Erectile Function [Срок оценки: Baseline and 6 months after surgery]
• Successful Penile Straightening [Срок оценки: 6 months after surgery]

Вторичные конечные точки (1)

• Erection Hardness Score [Срок оценки: Baseline and 6 months after surgery]

Критерии участия

Критерии включения

• \- 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Tekirdag Namik Kemal University Faculty of Medicine Hospital — Tekirdağ

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07470528 · Peyronie Disease

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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