Patient satisfaction and feasibility with a novel drug-injectable urethral catheter set for hyaluronic acid administration: a multicenter randomized trial

Reducing the risk of urethral strictures after transurethral surgery for patients with bladder cancer requires effective strategies. We compared the clinical outcomes of a novel drug-injectable urethral catheter set (NIUS) with hyaluronic acid (HA) with those of the conventional intraurethral HA injection method. This six-center, prospective, randomized, single-blind trial included 192 male patients aged ≥ 20 years scheduled to undergo transurethral surgery. The primary outcome was patient-reported satisfaction. Secondary outcomes were patient-reported pain intensity, clinician-reported convenience, and urethral strictures. Cystourethroscopy was performed under direct visualization. Outcomes of the experimental (NIUS with HA) and control (HA) groups were compared using the chi-square test and t-test. The post-transurethral surgery rate was significantly higher in the experimental group than in the control group (p < 0.001). Overall, 40% and 21.7% of patients in the experimental and control groups, respectively, were very satisfied (p < 0.001). The experimental group had lower postoperative pain intensity scores (p < 0.001), higher clinician-reported convenience scores (p < 0.001), and fewer urethral strictures within 3 months postoperatively (p < 0.001) than the control group. The NIUS with HA after transurethral surgery significantly enhanced patient satisfaction, reduced pain, improved clinician convenience, and was associated with a reduction in grade 1 urethral strictures. Thus, NIUS with HA enhances post-surgery outcomes through improved patient satisfaction and reduced urethral strictures.Trial registration: Cris.nih.go.kr (KCT0007010).