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Recruiting NCT07317297

Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease

No phase Interventional Peyronie Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extracorporeal Shockwave Therapy, control.
Who it may be relevant to
Registry conditions: Peyronie Disease. Basic parameters: 18 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Azerbaijan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Investigation of the effectiveness of extracorporeal shock wave therapy in the treatment of Peyronie's disease.

Detailed description

The study is designed as a single-center, prospective clinical trial. Participants will be selected from among patients who present to the clinic and are diagnosed with stable stage Peyronie's disease. All participants who meet the eligibility criteria and provide written consent will undergo a standard Extracorporeal Shockwave Therapy protocol. All participants will be evaluated before and after treatment using the International Erectile Function Index-5 and the Quality of Life Questionnaire short form. The results will be statistically analyzed and interpreted.

Interventions

  • Other Extracorporeal Shockwave Therapy
    Extracorporeal Shockwave Therapy will follow a standard protocol. The treatment is planned as a total of 8 sessions (3000 pulses per session, 2.5 bar pressure, 15 Hz frequency) twice a week using a radial shockwave device. Focusing will be done on the penile shaft via gel according to the plaque localization, and shock waves will be applied to the plaque area.
  • Other control
    patients receiving normal routine pharmacological treatment without any special intervention

Primary outcome measures

  • Erectile function [Time frame: 5 weeks]
  • Short Form-36 [Time frame: 5 weeks]

Eligibility criteria

Inclusion criteria

  • Male individuals aged 18-65 years.
  • Having been diagnosed with Peyronie's Disease that has been stable (without increasing pain and curvature) for at least 6 months.
  • Presence of palpable penile plaque.

Exclusion criteria

  • Acute inflammatory stage (painful, progressive)
  • Having previously undergone surgery, needle therapy (e.g., Xiaflex), or Extracorporeal Shockwave Therapy for peyronie's disease.
  • Uncontrolled diabetes, severe coagulopathy, or receiving anticoagulant therapy.
  • History of penile cancer.
  • Severe erectile dysfunction.
  • Patients who are considered unable to comply with the study protocol or who cannot attend follow-up visits.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Azerbaijan · 1 center
  • Koreya Serq Tebabeti — Baku

Publications

  • Ergun M, Sagir S. Low-Intensity Extracorporeal Shock Wave Therapy and Platelet-Rich Plasma: Effective Combination Treatment of Chronic-Phase Peyronie's Disease. Arch Esp Urol. 2025 Mar;78(2):164-169. doi: 10.56434/j.arch.esp.urol.20257802.23. PMID 40191859
  • Porst H. Review of the Current Status of Low Intensity Extracorporeal Shockwave Therapy (Li-ESWT) in Erectile Dysfunction (ED), Peyronie's Disease (PD), and Sexual Rehabilitation After Radical Prostatectomy With Special Focus on Technical Aspects of the Different Marketed ESWT Devices Including Personal Experiences in 350 Patients. Sex Med Rev. 2021 Jan;9(1):93-122. doi: 10.1016/j.sxmr.2020.01.006 PMID 32499189
  • Rosenberg JE, Ergun O, Hwang EC, Risk MC, Jung JH, Edwards ME, Blair Y, Dahm P. Non-surgical therapies for Peyronie's disease. Cochrane Database Syst Rev. 2023 Jul 17;7(7):CD012206. doi: 10.1002/14651858.CD012206.pub2. PMID 37490423

Identifiers

NCT: NCT07317297 · Uskudar79

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗