Original Papers - Prostate
Vol. 97 No. 4 (2025)
https://doi.org/10.4081/aiua.2025.14248

Ultrasound guided urethral drug-coated balloon treatment: our experience in 20 men

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Received: 12 August 2025
Accepted: 14 September 2025
Published: 27 October 2025
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Urethral stricture, vesicourethral stricture, urethral drug-coated balloon treatment

Authors

Pietro Pepe
piepepe@hotmail.com
Urology Unit, Cannizzaro Hospital, Catania, Italy.
Giuseppe Candiano
Urology Unit, Cannizzaro Hospital, Catania, Italy.
Letterio D'Arrigo
Urology Unit, Cannizzaro Hospital, Catania, Italy.

Introduction: To evaluate the use of urethral drug-coated balloon (DCB) in the treatmentof recurrent urethral strictures.
Materials and methods: From January 2023 to June 2025, twenty males (median 69 years) with recurrent urethral strictures were evaluated: 7/20 (35%) had urethral-bladder neck stenosis following radical prostatectomy, 11/20 (55%) and 2/20 (10%) had bulbar and anterior stenosis. All the patients previously underwent in 19/20 cases endoscopic urethrotomy (1-3 times) and in one case urethroplasty for hyospadias; median flow max was 5/ml/sec and post voiding urine residual was 150 ml; one man had suprapubic catheter. Urethral stenosis was measured by ultrasound (US) using saline water injected through the external meatus; moreover, US guided urethral dilatation was performed. Strictures were pretreated with an uncoated balloon or by stenosis incision; the inflation of Optilume®  DCB occurred for 7 min to allow complete stricture dilation and paclitaxel delivery. Finally a 18 Ch catheter was allocated in the bladder and removed five days later. Clinical outcomes included: average Qmax, International Prostate Symptoms Score (IPSS), IPSS quality of life (QoL), International Index of Erectile Function (IEFF-5) and over time rate of repeated intervention (dilation, endoscopic urethrotomy or urethroplasty).
Results: None had side effects during and following the procedure; all the patients improved their IPSS, IEEF-5 and none underwent repeated urethral treatment during the follow up. QoL improved together with sexual activity; although, IPPS score and flow max were improved but not restored to normal values all the patients had a good QoL refusing additional instrumental evaluation during the follow up. In detail, at a median 12 months of follow up IPSS, QoL and post-voiding urine residual and IEEF-score improved of 63%, 60%, 78% and 50%, respectively.
Conclusions: Although the limited number of patients evaluated and follow up, DCB demonstrated a good alternative for men with anterior and posterior urethral stenosis who have an unsuccessful endoscopic urethrotomy or dilation who want to avoid urethroplasty.

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1. Carmali D, Ramos S, Duarte S, et al. Optilume® for urethral strictures: a comprehensive review. Cureus. 2025; 17:e82984. DOI: https://doi.org/10.7759/cureus.82984
2. Pang KH, Chapple CR, Chatters R, et al. A Systematic review and meta-analysis of adjuncts to minimally invasive treatment of urethral stricture in men. Eur Urol. 2021;80:467-479. DOI: https://doi.org/10.1016/j.eururo.2021.06.022
3. Mann RA, Virasoro R, DeLong JM, et al. A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. Can Urol Assoc J. 2021; 15:20-25. DOI: https://doi.org/10.5489/cuaj.6661
4. VanDyke ME, Morey AF, Coutinho K, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2023; 5:366-373. DOI: https://doi.org/10.1002/bco2.312
5. Elliott SP, Coutinho K, Robertson KJ, et al. One-year results for the ROBUST III randomized controlled trial evaluating the optilume® drug-coated balloon for anterior urethral strictures. J Urol 2022;207:866-875. DOI: https://doi.org/10.1097/JU.0000000000002346
6. Pepe P, Aragona F. Prostate needle biopsy: 12 vs. 18 cores -- is it necessary? Urol Int. 2005; 74:19-22. DOI: https://doi.org/10.1159/000082703
7. Fiorentino V, Pepe L, Zuccalà V, et al. Gleason score down and upgrading at radical prostatectomy in targeted vs. systematic prostate biopsy: Findings from an institutional cohort. Pathol Res Pract. 2025; 271:156040. DOI: https://doi.org/10.1016/j.prp.2025.156040
8. Pepe P, Pepe L, Fiorentino V, et al. Multiparametric MRI targeted prostate biopsy: When omit systematic biopsy? Arch Ital Urol Androl 2024; 96:12992. DOI: https://doi.org/10.4081/aiua.2024.12992
9. Fiorentino V, Martini M, Dell'Aquila M, et al. Histopathological ratios to predict Gleason score agreement between biopsy and radical prostatectomy. Diagnostics 2020; 11:10. DOI: https://doi.org/10.3390/diagnostics11010010
10. Pepe P, Pepe L, Tamburo M, et al. 68Ga-PSMA PET/CT evaluation in men enrolled in prostate cancer Active Surveillance. Arch Ital Urol Androl 2023;95:11322. DOI: https://doi.org/10.4081/aiua.2023.11322
11. Pepe P, Pennisi M. Prostate cancer diagnosis and management across twenty years of clinical practice: a single-center experience on 2,500 cases. Anticancer Res 2019; 39:1397-1401. DOI: https://doi.org/10.21873/anticanres.13254
12. Pepe P, Panella P, Savoca F, et al. Prevalence and clinical significance of prostate cancer among 12,682 men with normal digital rectal examination, low PSA levels ( DOI: https://doi.org/10.1159/000100833
13. Pepe P, Aragona F. PCA3 score vs PSA free/total accuracy in prostate cancer diagnosis at repeat saturation biopsy. Anticancer Res. 2011; 31:4445-4449.
14. Pepe P, Fraggetta F, Galia A, et al. PCA3 score and prostate cancer diagnosis at repeated saturation biopsy. Which cut-off: 20 or 35? Int Braz J Urol 2012; 38: 489-495. DOI: https://doi.org/10.1590/S1677-55382012000400008
15. Pepe P, Aragona F. Incidence of insignificant prostate cancer using free/total PSA: results of a case-finding protocol on 14,453 patients. Prostate Cancer Prostatic Dis. 2010; 13:316-319. DOI: https://doi.org/10.1038/pcan.2010.29
16. Aragona F, Pepe P, Motta M, et al. Incidence of prostate cancer in Sicily: results of a multicenter case-findings protocol. Eur Urol 2005;47:569-574. DOI: https://doi.org/10.1016/j.eururo.2004.11.007
17. Pepe P, Roscigno M, Pepe L, et al. Could 68Ga-PSMA PET/CT evaluation reduce the number of scheduled prostate biopsies in men enrolled in active surveillance protocols? J Clin Med. 2022;11:3473. DOI: https://doi.org/10.3390/jcm11123473
18. Pepe P, Pennisi M. Should 68Ga-PSMA PET/CT Replace CT and bone scan in clinical staging of high-risk prostate cancer? Anticancer Res. 2022; 42:1495-1498. DOI: https://doi.org/10.21873/anticanres.15621
19. Pepe P, Pepe L, Curduman M, et al. Ductal prostate cancer staging: Role of PSMA PET/CT. Arch Ital Urol Androl. 2024; 96:12132. DOI: https://doi.org/10.4081/aiua.2024.12132
20. Pepe P, Pennisi M. Erectile dysfunction in 1050 men following extended (18 cores) vs saturation (28 cores) vs saturation plus MRItargeted prostate biopsy (32 cores). Int J Impot Res. 2016; 28:1-3. DOI: https://doi.org/10.1038/ijir.2015.18
21. Pepe P, Candiano G, Pennisi M, Aragona F. Unusual indications for transrectal pelvic ultrasound. Arch Ital Urol Androl 2011;83:166-168.
22. Liu JS, Hofer MD, Oberlin DT, et al. Practice patterns in the treatment of urethral stricture among American urologists: a paradigm change? Urology 2015; 86:830-834. DOI: https://doi.org/10.1016/j.urology.2015.07.020
23. Bandini M, Basile G, Lazzeri M, et al. Optimizing decision-making after ventral onlay buccal mucosa graft urethroplasty failure. BJU Int 2023; 131:339-347. DOI: https://doi.org/10.1111/bju.15895
24. Aydemir H, Saglam HS, Köse O, et al. The effect of recurrent direct vision internal urethrotomy for short anterior urethral strictures on the disease course and the predictors of treatment failure. Can Urol Assoc J. 2019; 13:E366-E370. DOI: https://doi.org/10.5489/cuaj.5754
25. Erickson BA, Elliott SP, Voelzke BB, et al: Trauma and Reconstructive Network of Surgeons (TURNS): Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol. Urology 2014;84:213-216. DOI: https://doi.org/10.1016/j.urology.2014.01.054
26. Oszczudłowski M, Białek Ł, Vetterlein MW. Trauma and Reconstructive Urology Working Party of the European Association of Urology Young Academic Urologists: paclitaxel-coated balloon dilation for urethral stricture disease: 5 years of clinical insights and future directions for optilume. Eur Urol Focus 2025;S2405-69. DOI: https://doi.org/10.1016/j.euf.2025.03.013
27. Alhamdani Z, Ong S, Zhong W, Chin P. Optilume® drug-coated balloon may lower the re-treatment rate postintervention for challenging urethral stricture disease in long-term follow-up: a prospective cohort study. J Endourol 2024;38:1192-1200. DOI: https://doi.org/10.1089/end.2024.0318
28. Srikanth P, DeLong J, Virasoro R, Elliott SP. A drug-coated balloon treatment for urethral stricture disease: three-year results from the ROBUST III study. J Endourol. 2025:39:968-74. DOI: https://doi.org/10.1089/end.2024.0718
29. VanDyke M, Joshi E, Ceballos B, et al. Efficacy of the Optilume paclitaxel drug-coated balloon after urethroplasty: short-term results from a multicenter study. Ther Adv Urol 2025;17:17562872241312522. DOI: https://doi.org/10.1177/17562872241312522
30. Alnadhari I, Alshrani M, Alhattami A, et al. Drug-coated balloon (Optilume®) for the management of bulbar urethral stricture, our experience. Urol Res Pract 2025;51:66-69. DOI: https://doi.org/10.5152/tud.2025.25020
31. DeLong J, Virasoro R, Pichardo M, et al. Long-term outcomes of recurrent bulbar urethral stricture treatment with the Optilume drug-coated balloon: five-year Results from the ROBUST I study. J Urol 2025; 213:90-98. DOI: https://doi.org/10.1097/JU.0000000000004229
32. Ballesteros Ruiz C, Campos-Juanatey F, Povo Martín I, et al. Efficacy and safety of Optilume® paclitaxel-coated urethral dilatation balloon in real-life: experience in a Spanish multicenter study. Actas Urol Esp (Engl Ed) 2025; 49: 80-85. DOI: https://doi.org/10.1016/j.acuroe.2024.10.003
33. Estaphanous P, Khalifa AO, Makar Y. Efficacy and safety of optilume drug-coated balloon for urethral stricture treatment: a systematic review and meta-analysis. Cureus 2024; 16:e74069. DOI: https://doi.org/10.7759/cureus.74069
34. Tosev G, Damgov I, Kuehhas F, et al. Off-label use of the optilume drug-coated balloon in the treatment of bladder neck stenosis and vesicourethral anastomosis stenosis. Eur Urol Open Sci 2025;75:101-105. DOI: https://doi.org/10.1016/j.euros.2025.03.002

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Ultrasound guided urethral drug-coated balloon treatment: our experience in 20 men. (2025). Archivio Italiano Di Urologia E Andrologia, 97(4). https://doi.org/10.4081/aiua.2025.14248
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