Peyronie’s Disease Intervention Trials: Methodological Challenges and Issues
Abstract
Introduction Peyronie's Disease (PD) has been studied for more than 260 years since Francois de la Peyronie's description in 1743. Based on the current literature, the prevalence of PD seems 3-9% with an average age of onset in the fifth life decade. Much effort has been spent on developing nonsurgical treatment options to cure or at least prevent disease progression. Aim The recent examination of drug trials for erectile dysfunction has led us to assess PD trial methodology more closely. Methods An Iinternet search on PubMed was performed using MeSH words PD, clinical trials, oral, transdermal, intralesional and shock wave therapy focusing on 26 representing studies published over the last 15 years. Mean Outcome Measures. A comprehensive review of the current literature on nonsurgical treatment options for PD was conducted to address methodological issues and challenges in PD trials highlighting trial design, patient population, and symptom and sign assessment. Results The majority of the reviewed studies are underpowered and the heterogeneity in the methodological approach and patient assessment between the studies is one of the remarkable findings from our review. Studies should use a uniform means of defining the degree and type of penile deformity and a large enough cohort of patients should be studied for adequate study power. An ideally designed PD intervention trial should comprise: (i) a randomized, placebo-controlled design; (ii) with a PD patient set representative…
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The PD literature suffers from major weaknesses in study methods.
“The published literature is hampered by significant shortcomings in study methodology.21, 22”
From Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation. (2021) · cites this paper as [22]
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FIBROPLASTIC INDURATION OF THE PENILE
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- Authors
- Müller, A., & Mulhall, J. P.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Corresponding author
- Mulhall, John P.
- ORCID
- Mulhall, John P.
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-03-01
- Volume
- 6
- Issue
- 3
- Pages
- 848-861
- ISSN
- 1743-6095 (ISSN-L)
- 1743-6109
- OpenAlex
- W2066488908
- Cited by
- 80
- References
- 56
- Citations by year
- 2026: 1 · 2025: 3 · 2023: 1 · 2022: 4 · 2021: 8 · 2020: 6 · 2019: 5 · 2018: 6 · 2017: 1 · 2016: 1 · 2015: 6 · 2014: 8 · 2013: 12 · 2012: 6
- FWCI
- 0.52
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- The Journal of Sexual Medicine (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Medicine › Rheumatology › Dupuytren's Contracture and Treatments
- Health Sciences › Medicine › Urology › Urological Disorders and Treatments
- Keywords
- Peyronie's disease, clinical trial design, trial design, intralesional therapy, shock wave therapy, study power, sexual function, pain, consensus recommendations
- MeSH terms
- Drug Therapy, Humans, Male, Penile Induration, Randomized Controlled Trials as Topic
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