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Peyronie's Disease (PD)PeyronieNCT07470528

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

A study testing Subtunical microdissection and grafting and Classic plaque Incision and Grafting in people with Peyronie's Disease (PD), run by Namik Kemal University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Peyronie's Disease (PD)
What is being tested?
Subtunical microdissection and grafting and Classic plaque Incision and Grafting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 May 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • - 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Tekirdag Namik Kemal University Faculty of Medicine Hospital

    Tekirdağ, 59100

    Çağrı doğan, M.D., 05558908805 ext. +90, drcagridogan@gmail.com

    Mehmet Fatih Şahin, M.D., 5555511871 ext. +90, mfatihsahin@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the 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.

Being tested
Subtunical microdissection and grafting, Classic plaque Incision and Grafting
Keywords
Peyronie's Disease, Complex Peyronie's Disease, Subtunical Microdissection, Plaque Incision and Grafting, Penile Reconstruction
Medical subject headings
Penile Induration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subtunical microdissection and graftingProcedure or surgery

    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.

  • Classic plaque Incision and GraftingProcedure or surgery

    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.

Study groups in NCT07470528
Study groupRoleWhat they receive
Subtunical Microdissection and GraftingExperimentalParticipants 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.
Receives: Procedure: Subtunical microdissection and grafting
Classic Plaque Incision and GraftingActive comparatorParticipants 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.
Receives: Procedure: Classic plaque Incision and Grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 months after surgery

  2. 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.

    Measured: 6 months after surgery

Secondary outcomes (1)
  1. Erection Hardness Score

    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

    Measured: Baseline and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start27 May 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07470528
Sponsor's protocol ID
Peyronie Disease
Acronym
Peyronie
Status last verified
Jul 2026
First submitted
10 Mar 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be available to protect participant privacy.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 15541152

Questions about this trial

What is this clinical trial studying?

A study testing Subtunical microdissection and grafting and Classic plaque Incision and Grafting in people with Peyronie's Disease (PD), run by Namik Kemal University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Erectile Function (time frame: Baseline and 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07470528, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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