Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease
ConditionPeyronie Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUskudar University
About this trial
Investigation of the effectiveness of extracorporeal shock wave therapy in the treatment of Peyronie's disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Extracorporeal Shockwave Therapy
Other interventionExtracorporeal 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 interventionpatients receiving normal routine pharmacological treatment without any special intervention
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: controlActive comparator 1 intervention
Group B: Extracorporeal Shockwave TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
5 weeks2
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.
Time frame
5 weeksSponsors and contacts
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Source ClinicalTrials.gov