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

NCT07010900 | Recruiting DMC

• 1 other identifier: CB-PRP-TRAC1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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)

Conditions

Peyronie Disease; Penile Curvature; PRP Injection; Cord Blood; Randomised Clinical Trial; Penile Injection Therapy

Keywords

penile exteder; peyronie disease; prp; cord blood prp

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  using PDQ questionnaire

  From enrollment to the end of follow-up at 6 months

Study Arms (2)

Penile extender

NO INTERVENTION

routine treatment with medical device

CB-PRP Injection

EXPERIMENTAL

experimental arm

Procedure: Injection

Interventions

Injection PROCEDURE

patients randomized in intervention group will use also penile extender

Also known as: CB-PRP

CB-PRP Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 23421851 RESULT

• 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.

  PMID: 38106680 RESULT

• Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.

  PMID: 16921694 RESULT

• Marcovici, I. PRP and Correction of Penile Curvature (Peyronie's Disease). Am J Cosm Surg, 2018. 36: 117.

  RESULT

• Usta MF, Ipekci T. Penile traction therapy for Peyronie's disease-what's the evidence? Transl Androl Urol. 2016 Jun;5(3):303-9. doi: 10.21037/tau.2016.03.25.

  PMID: 27298777 RESULT

• 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.

  PMID: 18638001 RESULT

• 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.

  PMID: 2231932 RESULT

• 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.

  PMID: 17983892 RESULT

MeSH Terms

Conditions

Penile Induration; Insomnia, Fatal Familial

Interventions

Injections

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Prion Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Franco Gadda, MD

CONTACT

+390255033478; franco.gadda@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

IT (1)