Platelet-Rich Plasma for Peyronie's Disease
ConditionPeyronies Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHerlev Hospital
About this trial
The purpose of this clinical trial is to evaluate the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Be able to provide written informed consent
Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).
Penile curvature of 30-95 degrees
Disqualifiers
Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
Hourglass malformation
Severely calcified plaques where injection is considered unfeasible
Intrapenile plaque
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous Platelet Rich Plasma
Other intervention6 mL PRP intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.
Saline solution
Other intervention6 mL saline solution intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Platelet Rich Plasma (PRP)Experimental treatment 1 intervention
Group B: Saline Solution (Placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Degree Changes in Penile Curvature.
Dominant curvature angles will be measured bedside in the outpatient clinic using a goniometer following intracavernosal administration of Alprostadil to ensure high quality and consistency. At the same visit, standardized photographs of the erect penis will be captured (in two plans) to support objective assessment. These procedures will be performed at baseline and at follow-up three months after the final injection. At the 6- and 12-months long-term follow-up visits, no pharmacological erection induction will be performed. Instead, penile curvature will be assessed based on standardized photographs of the participant's erection taken at home following detailed instructions, allowing evaluation of the durability of any treatment effect.
Time frame
From enrollment to 12 months post intervention.Secondary outcomes
1
Changes in Plaque Size
Plaque size will be measured at baseline and 3, 6 and 12 months after the final injection using a ruler, calculated as the product of plaque length and width. Participants with more than two plaques or with significant plaque heterogeneity will not have plaque size measured and will be excluded from these analyses but may still participate in the study.
Time frame
From enrollment to 12 months post intervention.2
Changes in the Peyronie's Disease Questionnaire (PDQ)
The Peyronie's Disease Questionnaire (PDQ) is a 15-question self-reported survey that measures the impact and severity of Peyronie's disease (PD) symptoms in 3 domains, including psychological and physical symptoms, penile pain and symptom bother. Higher domain scores indicate a greater negative impact. The range of scores for each domain is 0 to 24 for PD psychological and physical symptoms, 0 to 30 for penile pain and 0 to 16 for PD symptom bother. The participants will complete the survey at baseline and 3, 6 and 12 months after the final injection.
Time frame
From enrollment to 3 months post intervention.3
Changes in the Erection Hardness Score (EHS)
The participants will rate the hardness of their erection via the single-item Likert scale EHS, at baseline and 3, 6 and 12 months after the final injection. The scale is from 0-4. 0 is no erection, the higher the score the better erection.
Time frame
From enrollment to 12 months post intervention.4
Changes in the Major Depression Inventory (MDI)
The Major Depression Inventory (MDI) is a patient-reported outcome measure to assist with diagnosing and evaluation of the severity of a patient's depression. The MDI score ranges from 0 to 50, where 0 represents no depression symptoms and 50 represents the most severe depression symptoms. The participants will complete the MDI questionnaire at baseline and 3, 6 and 12 months after the final injection. The MDI is included due to previously described associations between Peyronie's disease and depression. The data may be used to assess the impact of disease progression on potential depressive symptoms.
Time frame
From enrollment to 12 months post intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev Hospital
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Source ClinicalTrials.gov