Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease

NCT07317297 | Recruiting

• 1 other identifier: Uskudar79
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peyronie Disease

Outcome Measures

Primary Outcomes (2)

• Erectile function

  The International Index of Erectile Function is recorded as a total score. It is measured by a self-reported questionnaire with 5 domains, with each domain consisting of 5 options. The score ranges from 5 to 25, with 5 being the lowest score (severe erectile dysfunction) and 25 being the best score (maximal erection)

  5 weeks

• Short Form-36

  Short Form-36 Health Survey is a non-disease-specific instrument consisting of 36 items used to assess health-related quality of life. It includes eight subscales covering physical and mental health domains. Each subscale is scored from 0 to 100, with higher scores indicating better health status, while one item assessing health change is not included in subscale scoring. A high score indicates a higher quality of life.

  5 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

patients receiving normal routine pharmacological treatment without any special intervention

Other: control

Extracorporeal Shockwave Therapy

EXPERIMENTAL

Patients receiving Extracorporeal Shockwave Therapy treatment

Other: Extracorporeal Shockwave Therapy

Interventions

Extracorporeal Shockwave Therapy OTHER

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.

Extracorporeal Shockwave Therapy

control OTHER

patients receiving normal routine pharmacological treatment without any special intervention

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: diseases specific to men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Koreya Serq Tebabeti

Baku, Azerbaijan

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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. Epub 2020 Jun 2.

  PMID: 32499189 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Penile Induration

Interventions

Extracorporeal Shockwave Therapy

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)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Aziz Azizov

  Uskudar University

  STUDY CHAIR

Central Study Contacts

Ömer ŞEVGİN

CONTACT

+905069787535; omer.sevgin@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 5, 2026
• Study Start: January 10, 2026
• Primary Completion: February 15, 2026
• Study Completion: March 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AZ (1)