Restorative therapy clinical trials for erectile dysfunction: a scoping review of endpoint measures.
Journal
International journal of impotence research
ISSN: 1476-5489
Titre abrégé: Int J Impot Res
Pays: England
ID NLM: 9007383
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
22
04
2022
accepted:
23
08
2022
revised:
18
08
2022
pubmed:
7
9
2022
medline:
7
9
2022
entrez:
6
9
2022
Statut:
ppublish
Résumé
Given the lack of regulatory approval for restorative therapies for the treatment of erectile dysfunction, we hypothesized that clinical trials would vary in methodology and endpoint measurements. Our objective was to analyze methodological approaches and outcome measures of clinical trials evaluating restorative therapies for erectile dysfunction. Data was extracted from clinicaltrials.gov on trials which contained the keywords "erectile dysfunction". We evaluated trials initiated between 2004 and 2021 which listed a restorative therapy intervention. We identified 95 trials investigating energy-based/shockwave therapies (60/95), stem cell therapies (25/95), platelet-based therapies (6/95), and others (4/95). Only 41.1% of the trials evaluated safety. The most common efficacy endpoint was International Index of Erectile Function and Sexual Health Inventory for Men, and only 29.5% utilized penile Doppler. Thirty (31.6%) trials had been completed yet only 3 (3.2%) have published results. We found substantial heterogeneity in methodological approach in the trials. Subjective measures of erectile function were commonly reported, but definitions of inclusion criteria and objective outcome measures were inconsistent. These results provide a basis for the design of future clinical trials to improve the quality of trial data and aid in the development of standardized criteria for erectile dysfunction clinical trials.
Identifiants
pubmed: 36068326
doi: 10.1038/s41443-022-00610-3
pii: 10.1038/s41443-022-00610-3
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
720-724Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Limited.
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