Safety and efficacy in Sclerotherapy of testicular hydro/spermatocele with 25 versus 50 mL Ethanol 99.5%; a randomised controlled phase II study

Objective: To investigate the dose-dependent safety and efficacy of using Ethanol 99.5% as a sclerosing agent when treating hydro- and spermatoceles. Materials and methods: This study (EUDRA-CT 2020-004630-38) was conducted as an open randomised multicentre study where symptomatic hydro- or spermatocele patients were randomised to sclerotherapy with 25- or 50-mL Ethanol 99.5%. The procedure was carried out at four Swedish outpatient clinics. An 8 F pigtail catheter was inserted after local anaesthetics of the skin, the fluid was drained and the randomised dose of Ethanol was instilled. After 30 min, the Ethanol was evacuated. Absorption was measured before and after instillation with a breathalyser and with a blood alcohol test before evacuation. Patients were followed-up by phone on days 1, 2, 3, 4, 30 and 90 after the procedure to capture any complications. Results: A total of 64 patients were included in this study. None had a significant absorption of alcohol (≥ 0.2‰). The rate of complications was 18%. The number of serious complications needing intervention was 5%. The overall success rate, defined as light or no remaining discomfort, of the treatment regardless of dose was 79%. There was no difference between the different regimens with regards to complications and the success rate, but this study is underpowered in regard to those analysis. Conclusions: No systemic absorption of Ethanol 99.5% occurred regardless of dose, when used as a sclerosing agent for hydro- and spermatoceles with a 79% cure rate. The efficacy and risks of complications are comparable to other sclerosants.