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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.
The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. A total of 84 patients with Peyronie's disease will be included. Participants will be stratified based on the degree of penile curvature at baseline (30-60 degrees or >60 degrees) and randomized in a 1:1 ratio to receive either active treatment with Platelet-Rich Plasma (PRP) or placebo (saline). Subsequently, participants will attend weekly injection sessions for 3 weeks consisting of either PRP or saline in a randomized, double-blind manner. A follow-up visit will take place three months after the final injection for outcome assessment. Two additional long-term follow-up visits will be conducted at 6 and 12 months post-treatment. Analysis will then be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental |
| |
| Saline Solution (Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma | Other | 6 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 12 months post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 12 months post intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikael Heering, MD, Ph.d. student | Contact | +4538688964 | mikael.heering@regionh.dk | |
| Mikkel M. Fode, Professor, MD, Ph.d. | Contact | +4538682093 | mikkel.mejlgaard.fode@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mikkel M. Fode, Professor, MD, Ph.d. | Herlev and Gentofte University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte University Hospital | Recruiting | Herlev | 2100 | Denmark |
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| ID | Term |
|---|---|
| D010411 | Penile Induration |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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The participant and the investigator/treating doctor will be masked. The syringes will be covered. Only the care provider who prepare the PRP will not be masked.
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|
| Saline solution | Other | 6 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. |
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| 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. | From enrollment to 3 months post intervention. |
| 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. | From enrollment to 12 months post intervention. |
| 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. | From enrollment to 12 months post intervention. |
| The Ability to Engage in Sexual Intercourse (question) | The participants will be assessed at baseline and 3, 6 and 12 months after the final injection regarding their ability to engage in sexual intercourse. This will be assessed by asking participants a single binary question: whether they are able to engage in sexual intercourse (yes or no). | From enrollment to 12 months post intervention. |
| Preference for Surgical Intervention (question) | The participants will be inquired about their preference for surgical intervention in relation to the current penile curvature at baseline and 3, 6 and 12 months after the final injection. This will be assessed by asking participants a single binary question: whether they wish to undergo surgery given their current curvature (yes or no). | From enrollment to 12 months post intervention. |
| Changes in Global Assessment Scale Questionnaire | The participants will complete a Global Assessment Scale Questionnaire regarding overall treatment satisfaction at the 3-, 6- and 12 months follow-up after the final injection. The questionnaire consists of a single question regarding the participants' overall satisfaction with the treatment, to be answered on a scale from 1 to 5. A higher value indicates greater satisfaction. | From 3 to 12 months post intervention. |
| D052801 |
| Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |