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Use of Optilume Balloon Dilation for Urethral Strictures in a Pediatric Population
Amanda M. Nguyen, MD, Brian P. Wiseman, MD, Glen A. Lau, MD, Anthony J. Schaeffer, MD, M. Chad Wallis, MD, Patrick C. Cartwright, MD, Raymond T. Yong, MD, Deborah L. Jacobson, MD.
Primary Children's Hospital, Salt Lake City, UT, USA.
Background: Pediatric urethral stricture disease leads to substantial morbidity, and surgical management has been associated with both erectile dysfunction and stricture recurrence. Optilume (Laborie Medical Technologies Corporation, Portsmouth, NH) is a paclitaxel-coated balloon indicated for treatment of urethral strictures ≤ 3 cm in adult males. Five-year follow-up data from the ROBUST I trial demonstrated freedom from re-treatment among ~72% of men with recurrent bulbar urethral strictures, and the updated American Urological Association guidelines provide a conditional recommendation for use of drug-coated balloons for recurrent bulbar urethral stricture disease. Given the favorable efficacy profile in adults, the Optilume device has been used off-label in a subset of pediatric patients with urethral stricture disease at our institution. We report the short-term outcomes of Optilume balloon dilation in these patients.
METHODS: Boys aged ≤ 18 years undergoing cystoscopy with Optilume balloon dilation at a single, freestanding children’s hospital in January 2018 to April 2026 were identified through a retrospective review of operative records. Boys underwent diagnostic cystourethroscopy and pre-dilation with an uncoated high-pressure ballon or sequential dilators prior to deployment of the 18F or 30F drug-coated Optilume balloon; early in our experience two patients were not pre-dilated. The Optilume balloon was left inflated for 5 minutes prior to deflation and indwelling catheter placement. Catheters were left in place for 3 to 11 days and removed at a clinic appointment; one patient was left without an indwelling catheter due to behavioral factors. Descriptive statistics were performed.
RESULTS: Seven boys met inclusion criteria. All procedures were performed between April 2022 and July 2025. Patients were a median 17.3 years old (range 10.6-18.0), primarily White (86%), and privately insured (72%). Additional patient demographics are reported in Table 1. Six patients (86%) presented with bulbar urethral strictures and one presented with a pendulous urethral stricture. Six patients presented with idiopathic stricture disease and one presented with a post-procedural stricture following proximal hypospadias repair. Procedure characteristics are reported in Table 2. There were no peri-procedural complications. The median pre-procedural maximum flow rate (Qmax) in the four patients with data was 13.5mL/sec (range 8-20). The median post-procedural Qmax and average flow rate in the four patients with data were 19.8mL/sec (range 12.5-43) and 10.6 (range 8.0-32.1). Four patients remain free from intervention or planned intervention at a median 13.9 months since the procedure (range 9.6-23.2); three of these have no evidence of stricture disease and a fourth has a soft 14F stricture that is being monitored. One patient underwent a second Optilume dilation and has not had recurrence. Urethroplasty is planned in two patients.
CONCLUSIONS: Optilume balloon dilation was safe with modest results in a small cohort of pediatric patients. Larger studies are required for more robust results reporting.
Patient Demographics| Demographic Characteristic | N | % |
| Age (Median, Range) | 17.3 (10.6-18.0) | |
| Race/Ethnicity | | |
| White | 6 | 86% |
| Hispanic | 1 | 14% |
| Insurance Type | | |
| Commercial | 5 | 72% |
| Medicaid | 1 | 14% |
| Self-pay | 1 | 14% |
Patient and Procedure Characteristics| Patient | Age (Years) | Stricture Location | Prior Procedure | Stricture Size | Optilume Size | Post-op Catheter Size | Time Since Intervention | Endpoints |
| A* | 10.6 | Bulbar | None | 5Fr | 18Fr x 3cm | 12Fr | 13.9 months | No recurrence |
| B* | 16.3 | Bulbar | DVIU | 3Fr | 30Fr x 3cm | 18Fr | 23.0 months | Recurrent short segment stricture ~14F, no intervention to date |
| C | 17.2 | Bulbar | DVIU | 8Fr | 18Fr x 3cm | None | 23.2 months | No recurrence |
| D | 17.3 | Pendulous | Proximal hypospadias repair | 5Fr | 18Fr x 3cm | 14Fr | 13.5 months | Recurrent stricture, repeat Optilume, no recurrence after second Optilume |
| E | 17.4 | Bulbar | None | 6Fr | 30Fr x 5cm | 16Fr | 10.0 months | Recurrent stricture, urethroplasty planned |
| F | 17.7 | Bulbar | None | 5Fr | 30Fr x 5cm | 18Fr | 9.6 months | Recurrent stricture, urethroplasty planned |
| G | 18.0 | Bulbar | Buccal urethroplasty | 8Fr | 30Fr x 3cm | 14 Fr | 23.1 months | No recurrence |
| *No predilation before Optilume procedure | | | | | | | | |
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