Peyronie Disease
Conditions
Brief summary
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.
Interventions
OTHERExtracorporeal 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.
OTHERcontrol
patients receiving normal routine pharmacological treatment without any special intervention
Sponsors
Uskudar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile function | 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 | 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. |
Countries
Azerbaijan
Contacts
CONTACTÖmer ŞEVGİN
STUDY_CHAIRAziz Azizov
Uskudar University
Outcome results
None listed