Many treatments for LUTS/BPH have negative effects on sexual function. Data from a prospective, randomized, double-blind, sham controlled study evaluating the Urocross Expander was evaluated to determine the impact of treatment with this novel technology on sexual function. The Urocross Expander is a novel MIST that combines mechanical urethral dilation with urethral reshaping using a non-permanent nitinol device removed after 6 months.
240 subjects were randomized in a 2:1 fashion to receive the Urocross or Sham (160:80). Baseline measures included assessments via the International Index of Erectile Function (IIEF) and Men’s Sexual Health Questionnaire – Ejaculatory Dysfunction (MSHQ-EjD). Men were queried regarding history of ErectileDysfunction (ED) at the baseline (BL).
Baseline IIEF and MSHQ-EjD were similar between the Urocross and Sham arms for sexually active subjects (IIEF 16.0±6.3 vs 16.5±5.9, MSHQ-EjD 8.2±3.3 vs 8.9±3.2). A total of 132 men randomized in the Urocross Arm claimed they are sexually active at BL. Men with active sexual activity reported overall better score of IIEF from BL, with the average IIEF score improved from 16.0 (n=132) at baseline to 17.7 (n=67) at 1yr post treatment, indicating a categorical change from “Mild to Moderate ED” to “Mild ED” (Figure 1A). At 7mo post-treatment (1mo post-retrieval), men with severe ED improved the most and men with no ED before surgery are maintained at the BL level (Figure 1B). Men with active sexual activity also report overall better score of MSHQ from BL through 12 months. MSHQ score has an average of 2.0 improvement at 12mo (6mo post-retrieval), regardless of their history of ED or not.
Treatment with Urocross resulted in significant symptom relief while preserving erectile and ejaculatory function. These results offer support for the use of Urocross in men seeking treatment for LUTS/BPH who are concerned with preserving sexual function.
ProDeon, Inc: NCT05400980
