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NCT Number: NCT07317297

Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease

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

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Key information

Conditions

Peyronie Disease Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Penile Induration Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Koreya Serq Tebabeti

Baku, Azerbaijan

Location status: Recruiting

Location contact

Aziz Azizov

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Other

patients receiving normal routine pharmacological treatment without any special intervention

Primary outcomes

  1. 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)

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer ŞEVGİN

CONTACT

[email protected]

+905069787535

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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