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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:
Participants will be randomized in two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penile extender | No Intervention | routine treatment with medical device | |
| CB-PRP Injection | Experimental | experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection | Procedure | patients randomized in intervention group will use also penile extender |
|
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | using PDQ questionnaire | From enrollment to the end of follow-up at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Coagulopathies, platelet disorders Major active infections Previous penile surgery (excluding circumcision and condyloma removal) Previous infiltrative therapy or penile traction treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franco Gadda, MD | Contact | +390255033478 | franco.gadda@policlinico.mi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23421851 | Result | 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. | |
| 38106680 | 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. |
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| 16921694 | 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. |
| Result | Marcovici, I. PRP and Correction of Penile Curvature (Peyronie's Disease). Am J Cosm Surg, 2018. 36: 117. |
| 27298777 | 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. |
| 18638001 | 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. |
| 2231932 | 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. |
| 17983892 | 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. |
| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D034062 | Insomnia, Fatal Familial |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017096 | Prion Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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