Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease

NCT ID: NCT07317297

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Peyronie Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

patients receiving normal routine pharmacological treatment without any special intervention

Group Type ACTIVE_COMPARATOR

control

Intervention Type OTHER

patients receiving normal routine pharmacological treatment without any special intervention

Extracorporeal Shockwave Therapy

Patients receiving Extracorporeal Shockwave Therapy treatment

Group Type EXPERIMENTAL

Extracorporeal Shockwave Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

control

patients receiving normal routine pharmacological treatment without any special intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Doç.Dr.Ömer Şevgin

Assoc.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aziz Azizov

Role: STUDY_CHAIR

Uskudar University

Locations

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Koreya Serq Tebabeti

Baku, , Azerbaijan

Site Status RECRUITING

Countries

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Azerbaijan

Central Contacts

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Ömer ŞEVGİN

Role: CONTACT

+905069787535

Facility Contacts

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Aziz Azizov

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 40191859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32499189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37490423 (View on PubMed)

Other Identifiers

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Uskudar79

Identifier Type: -

Identifier Source: org_study_id

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