Peyronie DiseaseNCT07317297
Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease
A study testing Extracorporeal Shockwave Therapy in people with Peyronie Disease, run by Uskudar University at 1 site in Azerbaijan.
Trial summary
Investigation of the effectiveness of extracorporeal shock wave therapy in the treatment of Peyronie's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- Extracorporeal Shockwave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 10 Jan 2026to 30 Mar 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Azerbaijan1 site, 1 recruiting
- Recruiting
Koreya Serq Tebabeti
Baku
Aziz Azizov, azizazizovv798@gmail.com
About this study
Investigation of the effectiveness of extracorporeal shock wave therapy in the treatment of Peyronie's disease.
Read the 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.
- Conditions
- Peyronie Disease
- Being tested
- Extracorporeal Shockwave Therapy, control
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyOther
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.
controlOther
patients receiving normal routine pharmacological treatment without any special intervention
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | patients receiving normal routine pharmacological treatment without any special intervention Receives: Other: control |
| Extracorporeal Shockwave Therapy | Experimental | Patients receiving Extracorporeal Shockwave Therapy treatment Receives: Other: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start10 Jan 2026
- Primary completion15 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doç.Dr.Ömer Şevgin, Uskudar University
- Investigators
- Aziz Azizov, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317297
- Sponsor's protocol ID
- Uskudar79
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40191859Porst 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.
PubMed 32499189Rosenberg 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.
PubMed 37490423
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease
- ClinicalTrials.gov ID
- NCT07317297
- Acronym / sponsor ID
- Uskudar79
- Conditions
- Peyronie Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: controlpatients receiving normal routine pharmacological treatment without any special intervention |
| Extracorporeal Shockwave Therapy | Experimental | Other: Extracorporeal Shockwave TherapyPatients receiving Extracorporeal Shockwave Therapy treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave TherapyExtracorporeal 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 | Extracorporeal Shockwave Therapy |
| controlpatients receiving normal routine pharmacological treatment without any special intervention | Other | control |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 40191859Ergun 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.
- Background: PubMed 32499189Porst 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.
- Background: PubMed 37490423Rosenberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aziz Azizov study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy in people with Peyronie Disease, run by Uskudar University at 1 site in Azerbaijan.
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 3 inclusion and 6 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 16 Jan 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 Azerbaijan. 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?
Contact Ömer ŞEVGİN (+905069787535, omer.sevgin@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile function (time frame: 5 weeks). 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 NCT07317297, 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 16 Jan 2026.