Clinical trial NCT06789510: Treatment of Peyronie's Disease with Platelet-Rich Plasma
Official title: Treatment of Peyronie's Disease with Platelet-Rich Plasma: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peyronies Disease
Keywords: PRP
Platelet-Rich Plasma
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive six injections (three Platelet-Rich Plasma (PRP) and three saline), administered weekly in a randomized sequence. The RedCap randomization module ("Research Electronic Data Capture", a data management system used for research data) will ensure that each participant receives three injections of each type.
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.

Detailed description: 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. Subsequently, participants will attend weekly injection sessions for 6 weeks, during which they will receive 3 PRP injections and 3 saline injections (placebo) in a randomized order. Three months after the final injection, participants will attend a follow-up visit, where the final data will be collected. Analysis will then be conducted.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
* Hourglass malformation
* Severely calcified plaques where injection is considered unfeasible
* History of priapism.
* History of penile fracture.
* Previous treatment for PD with injections and/or surgery.

Primary outcomes:
measure: Platelet Concentration in the PRP
timeFrame: The 6 week intervention period.
measure: Evaluation of the Blinding Process
timeFrame: The 6 week intervention period.
Secondary outcomes:
measure: Adverse Events
timeFrame: From the first injection to the 3 months post intervention follow-up.
measure: Degree Changes in Penile Curvature.
timeFrame: From enrollment to 3 months post intervention.
measure: Changes in Plaque Size
timeFrame: From enrollment to 3 months post intervention.
measure: Changes in the Peyronie's Disease Questionnaire (PDQ)
timeFrame: From enrollment to 3 months post intervention.
measure: Changes in the Erection Hardness Score (EHS)
timeFrame: From enrollment to 3 months post intervention.
measure: Changes in the Major Depression Inventory (MDI)
timeFrame: From enrollment to 3 months post intervention.
measure: The Ability to Engage in Sexual Intercourse (question)
timeFrame: From enrollment to 3 months post intervention.
measure: Preference for Surgical Intervention (question)
timeFrame: From enrollment to 3 months post intervention.
measure: Satisfaction
timeFrame: From enrollment to 3 months post intervention.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte University Hospital
Study officials:
References: