Actas urologicas espanolas · 2021
Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol.
СтатьяНазвание и аннотация: Перевод в очереди
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García Cruz E, Mercader Barrull C, Camacho Rovira D, Alcaraz Asensio A
Аннотация
INTRODUCTION: Collagenase Clostridium histolyticum (CCH) is the only approved treatment for conservative management of Peyronie's disease (PD) that has demonstrated efficacy and safety in clinical trials. However, as the standard treatment protocol is time and resource consuming, we are introducing a new CCH treatment protocol with a more cost-effective profile. Our goal is to evaluate its efficacy and safety.
MATERIALS AND METHODS: We included patients with PD in stable phase, with curvatures of 30-90degrees. Ventral curvatures and complex deformities were excluded. The treatment protocol consists of a full dose of CCH injected along the PD plaque, forming two lines of four injections. Patients were educated in daily penile modeling activities. The need for a new treatment cycle, up to a maximum of 8 cycles or until the 30-degree curve was decreased, was reevaluated every 4weeks. Changes in curvature and number of cycles were recorded to evaluate the efficacy. Regarding safety evaluation, treatment-related adverse events (TRAEs) were recorded, including rupture of the corpora cavernosa, penile hematoma, hematuria, and local infection.
RESULTS: Thirty-one patients were treated under the modified protocol. The mean initial curvature was of 49.84 (±15.83) degrees. Curvature improvement was recorded in 25 patients (80.6%), with a mean absolute reduction of 20.65 (±15.42) degrees and relative reduction of 44%. The mean curvature after treatment was 30.67 (±17.25) degrees. Most patients required one (19.4%) or two (54.8%) injections. No patient presented TRAEs.
CONCLUSIONS: The results suggest that the modified CCH treatment protocol is effective and safe, but more studies should be carried out to optimize the current standard protocol.
MATERIALS AND METHODS: We included patients with PD in stable phase, with curvatures of 30-90degrees. Ventral curvatures and complex deformities were excluded. The treatment protocol consists of a full dose of CCH injected along the PD plaque, forming two lines of four injections. Patients were educated in daily penile modeling activities. The need for a new treatment cycle, up to a maximum of 8 cycles or until the 30-degree curve was decreased, was reevaluated every 4weeks. Changes in curvature and number of cycles were recorded to evaluate the efficacy. Regarding safety evaluation, treatment-related adverse events (TRAEs) were recorded, including rupture of the corpora cavernosa, penile hematoma, hematuria, and local infection.
RESULTS: Thirty-one patients were treated under the modified protocol. The mean initial curvature was of 49.84 (±15.83) degrees. Curvature improvement was recorded in 25 patients (80.6%), with a mean absolute reduction of 20.65 (±15.42) degrees and relative reduction of 44%. The mean curvature after treatment was 30.67 (±17.25) degrees. Most patients required one (19.4%) or two (54.8%) injections. No patient presented TRAEs.
CONCLUSIONS: The results suggest that the modified CCH treatment protocol is effective and safe, but more studies should be carried out to optimize the current standard protocol.