Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease

January 15, 2026 updated by: Doç.Dr.Ömer Şevgin, Uskudar University
Investigation of the effectiveness of extracorporeal shock wave therapy in the treatment of Peyronie's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

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 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
patients receiving normal routine pharmacological treatment without any special intervention
Other: control
patients receiving normal routine pharmacological treatment without any special intervention
Experimental: Extracorporeal Shockwave Therapy
Patients receiving Extracorporeal Shockwave Therapy treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile function
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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

Collaborators and Investigators

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

Sponsor

Uskudar University

Investigators

  • Study Chair: Aziz Azizov, Uskudar 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)

January 10, 2026

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 5, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar79

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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