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

Abstract 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 intraurethr...

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Main Authors: Sung Jin Kim, Han Kyu Chae, Wook Nam, Jong Yeon Park, Sang Hyun Park, Jae-Seung Chung, Cheol Kyu Oh, Sangjun Yoo, Min Chul Cho, Hyeon Jeong, Seong Cheol Kim, Sungchan Park, Won Ik Seo, Jae Il Chung, Chan Ho Lee, Kweonsik Min, Jimin Choi, Jungyo Suh, Bumjin Lim, Dalsan You
Format: Article
Language:English
Published: Nature Portfolio 2025-01-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-024-84164-y
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Summary:Abstract 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).
ISSN:2045-2322