Background: The improvement of absent or partial response in the medical treatment of erectile dysfunction (ED) has led to the development of minimally invasive new treatment modalities in the field of regenerative medicine. Methods: A literature review on stem cell therapy for the treatment of ED was performed. We searched for the terms “erectile dysfunction” and “stem cell therapy” in PubMed and Clinicaltrials.gov. Literature searching was conducted in English and included articles from 2010 to 2022. Results: New treatment modalities for ED involving stem cell therapy are not only conceived with a curative intent but also aim to avoid unnecessary adverse effects. Several sources of stem cells have been described, each with unique characteristics and potential applications, and different delivery methods have been explored. A limited number of interventional studies over the past recent years have provided evidence of a safety profile in their use and promising results for the treatment of ED, although there are not enough studies to generate an appropriate protocol, dose or cell lineage, or to determine a mechanism of action. Conclusions: Stem cell therapy is a novel treatment for ED with potential future applications. However, most urological societies agree that further research is required to conclusively prove its potential benefit.
Objectives: During 2019 there was a worldwide shortage of BCG strains for intravesical instillation, limiting the availability of full dose schemes for maintenance courses. The main objective of the present study is to analyze whether patients affected during the shortage by reduced dose courses, are at a higher risk of tumor recurrence than those receiving full dose schemes.
Methods: Retrospective cohort study with a total sample of 154 subjects (60 treated during 2019 and 94 during 2017) with high-risk non-muscle invasive bladder cancer and treated with a combination of Transurethral bladder resection (TURB) followed by adjuvant intravesical instillation with BCG.
Basal characteristics of both groups were analyzed. Times to event of interest (relapse; including recurrence and/or progression) were estimated by survival analysis using the Kaplan-Meier method. Relapse-free survival rates were analyzed using a multivariable Cox regression model of proportional hazards.
Results: Median follow-up in the 2019 sample was 503 days and 1197 days in the 2017 group, with a median number of instillations of 8 and 12 respectively. There was a 37.7% proportion of tumoral relapse observed in the 2019 group and 29.03% during 2017.
Survival analysis revealed mean relapse-free follow-up of 683 days (95%CI 601.3-765.5) in the 2019 group and of 1359 days (95%CI 1244.3-1474) in 2017. Further analysis using LogRank test revealed observed differences to be statistically significant (p=0.02)
Multivariable analysis revealed a proportional Hazard ratio (HR) for relapse-free survival rate of 2.2 (95% CI: 1.13-4.25; p=0.019) regarding the 2019 sample treated with a reduced-dose course.
Conclusions: BCG shortage and the subsequent reduced-dose schemes used for intravesical instillation, due to limited availability, had a significant impact on tumor relapse rates during follow-up. These findings are consistent with other published studies and show the need for full-dose BCG courses in order to prevent higher relapse rates after TURB.
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