THE END OF PHIMOSIS SURGERY? PILOT STUDY ON CLOSTRIDIUM HISTOLITICUM COLLAGENASES

This pilot multicentric study aims to evaluate the efficacy of therapy with Clostrium Histolyticum collagenase in the treatment of severe phimosis due to lichen sclerosus desease.

From January 2023 to February 2024, after signed the informed consent to the study, we enrolled 72 patients unwilling to undergo surgery with severe phimosis (Kikiros retractability grade > 3) and phimosis-related Erectil Disfunction. Only 45 patient meets the inclusion criteria. Patients were treated with injections into the phimotic area with 1500 IU of Clostridium Histolyticum collagenase with two injections 1 month apart. After 1 months and 2 moths of therapy, the GCI, Quol and IIEF5 test was administered. The variations based on the Kikiros score were evaluated.

38 patients (84.4%) of the patients had a benefit from the treatment while 7 patients had no benefit. All of previous patients had at baseline a Kikiros of 3. Only 4 patient with Kikiros classification 3 had benefit. The kikiros score was statistically significant at month 1 compared to baseline (p < 0.001) while it was not statistically significant between month 2 and month 1 (p = 0.074). Quality of life was statistically improved between baseline and month 1 (p < 0.001). No improvement in quality of life between month 2 and baseline (p = 0.79). Quol and kikiros score were statistically significant between month 2 and baseline (p < 0.001). At 1 Most patients achieved a GCI value of 2 while only a few recorded a value of 4. No variation in GCI was registered from 2 months and 1 month. IIEF 5 satistically significantly improved between baseline and month 1, while no improvement was recorded between months 1 and month 2. No adverse events were recorded.

Clostridium Histolyticum Collagenases appear to have an important therapeutic role in the treatment of lichen sclerosus phimosis and appear to be most effective in severe patients. No improvement was observed with a second injection at 1 month.

All authors have no conflict of interest to declare.