Clinical trial NCT07010900: Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease. Open-label, Single-center Randomized Study
Official title: Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peyronie Disease
Penile Curvature
PRP Injection
Cord Blood
Randomised Clinical Trial
Penile Injection Therapy
Keywords: penile exteder
peyronie disease
prp
cord blood prp
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) is useful in Peyronie disease.

The primary goal is evaluation of patient satisfaction at 1 and 3 months after treatment completion using the PDQ Questionnaire

Secondary Objectives are:

* Measurement of penile curvature measured with a goniometer with spontaneous erection before and after treatment (1 and 3 months)
* Measurement of penile length in stretching before and after treatment (1 and 3 months)
* Evaluation of the improvement in quality of life, through the Short-Form Health Survey 12 (SF-12) health status questionnaire and through the Hospital Anxiety and Depression Scale (HADS)

Participants will be randomized in two groups:

* penile extender alone
* penile extender + CB PRP injection (1 injection every 15 days - 3 in totalinjections)


Eligibility criteria: Inclusion Criteria:

* Patients with Peyronie's Disease (IPP) Penile curvature greater than 30 degrees (autophotography in erection with goniometer measurement) Patients candidates for penile traction Age: 18-75 years Good health conditions Preserved erection (IIEF \>20) Complete blood count with differential and coagulation within the normal range (platelets between 150,000 and 450,000 μL) HIV, HCV, and HbsAg negative The fertile partner of the patient randomized to the experimental group must use an acceptable highly effective contraceptive method (oral contraceptives, intrauterine device, abstinence, vasectomized partner) for the entire duration of the study Informed consent to the study

Exclusion Criteria:

Coagulopathies, platelet disorders Major active infections Previous penile surgery (excluding circumcision and condyloma removal) Previous infiltrative therapy or penile traction treatment

Primary outcomes:
measure: patient satisfaction
timeFrame: From enrollment to the end of follow-up at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study officials:
References:
citation: Chung E, De Young L, Solomon M, Brock GB. Peyronie's disease and mechanotransduction: an in vitro analysis of the cellular changes to Peyronie's disease in a cell-culture strain system. J Sex Med. 2013 May;10(5):1259-67. doi: 10.1111/jsm.12082. Epub 2013 Feb 19.
citation: Almsaoud NA, Safar O, Alshahrani ST, Alwadai R, Alkhaldi SM, Almurayyi M, Alrweili HH, Assiri HM, Al Jubran A, Hakami B, Alzahrani MA. The effect of penile traction device in men with Peyronie's disease on penile curvature, penile length, and erectile dysfunction: a systematic review and meta-analysis. Transl Androl Urol. 2023 Nov 30;12(11):1673-1685. doi: 10.21037/tau-23-310. Epub 2023 Nov 9.
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citation: Marcovici, I. PRP and Correction of Penile Curvature (Peyronie's Disease). Am J Cosm Surg, 2018. 36: 117.
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citation: Smith JF, Walsh TJ, Conti SL, Turek P, Lue T. Risk factors for emotional and relationship problems in Peyronie's disease. J Sex Med. 2008 Sep;5(9):2179-84. doi: 10.1111/j.1743-6109.2008.00949.x. Epub 2008 Jul 14.
citation: Gelbard MK, Dorey F, James K. The natural history of Peyronie's disease. J Urol. 1990 Dec;144(6):1376-9. doi: 10.1016/s0022-5347(17)39746-x.
citation: Taylor FL, Levine LA. Peyronie's Disease. Urol Clin North Am. 2007 Nov;34(4):517-34, vi. doi: 10.1016/j.ucl.2007.08.017.