Optilume BPH — Prostatic Drug-Coated Balloon System
Optilume BPH combines mechanical opening of the prostatic outlet with local paclitaxel delivery. It uses an uncoated predilation catheter followed by a separate drug-coated balloon, rather than a single interchangeable urethral-stricture balloon. The BPH balloon has a paclitaxel coating density of 2.4 µg/mm².[1]
For operative selection and technique, see Optilume BPH. For the distinct anterior-urethral-stricture product and its drug evidence, see Drug-Coated Balloon Therapy.
Device and Mechanism
The kit contains one uncoated 90 Fr x 30 mm pre-dilation catheter and one of four drug-coated balloons of the same diameter (30, 35, 40 or 45 mm treatment length). Each is a single-lumen balloon catheter with a 14.5 Fr folded profile, passed through the outer sheath of a rigid cystoscope. The balloon has two lobes separated by a reinforced neck. The distal lobe inflates in the bladder and anchors the device, and the neck seats at the bladder neck. The proximal lobe dilates the prostatic urethra and creates an anterior commissurotomy. Pre-dilation performs the commissurotomy first, and the coated balloon then transfers paclitaxel to the prostatic urothelium during inflation.[1]
The coated balloon is chosen by prostatic urethral length (PUL), measured by transrectal ultrasound in the mid-sagittal plane from the base of the bladder neck to the proximal edge of the external sphincter. If an intravesical prostatic protrusion is present, the measurement starts at the base of the bladder neck and not at the tip of the protrusion.[1]
| PUL | Balloon treatment length | Nominal paclitaxel dose |
|---|---|---|
| 32 to 37 mm | 30 mm | 10,262 µg |
| 37 to 42 mm | 35 mm | 11,433 µg |
| 42 to 47 mm | 40 mm | 12,567 µg |
| Above 47 mm | 45 mm | 13,661 µg |
The rationale offered for adding paclitaxel is to limit fibroblast proliferation and re-fusion of the lateral lobes after the commissurotomy. This is a manufacturer rationale, and the trial did not compare a coated with an uncoated balloon.[1]
Label and Safety
The US PMA indication is obstructive urinary symptoms associated with BPH in men aged 50 years or older. The pivotal trial enrolled men with 20–80 g prostates; this study population is separate from the wording of the labeled indication. The 2026 AUA guideline states that clinicians may offer an intraprostatic drug-coated balloon to patients with prostates of 20 to 80 cc, a prostatic urethral length of 32 to 55 mm and no obstructing median lobe (Conditional Recommendation; Evidence Level Grade C).[4] Balloon sizing, anatomy and eligibility must follow the BPH-specific instructions.[1]
- Contraindications include active UTI, paclitaxel-related hypersensitivity, an artificial urinary sphincter or a penile prosthesis.
- Use barrier protection during sex for 30 days after treatment. Men with partners of childbearing potential should use highly effective contraception and avoid fathering a child for at least 12 months. The label reports paclitaxel in semen in 4 of 5, 5 of 7, 4 of 10 and 1 of 3 evaluable men at 1, 3, 6 and 12 months. Effects on sperm and spermatogenesis are unknown. Do not substitute the shorter counseling interval from another Optilume product.
- Hematuria, infection, dysuria and retention can occur. An office or outpatient setting does not eliminate the need for a complication and catheter plan.
- Avoid damaging or prematurely wetting the drug coating. The coated balloon hydrates in the prostatic urethra for about 1 minute and is then inflated for at least 5 minutes, and after a failure at rated burst pressure a second coated balloon is not used. The prostatic urethra is not re-inspected with the cystoscope after the coated balloon, and the Foley catheter stays for at least 2 days. A rigid cystoscope with at least a 19.5 Fr sheath is required. Other preparation and handling steps follow the full BPH instructions.[1]
PINNACLE Evidence
PINNACLE randomized 148 men: 100 to Optilume BPH and 48 to sham. Its primary comparison used the active group's one-year IPSS improvement versus the sham group's three-month improvement. The reported 11.5 versus 8.0-point change must not be presented as a contemporaneous one-year sham comparison.[2] With the prespecified 25% super-superiority margin, the labeled analysis did not meet the primary endpoint (difference +1.4 points, p = 0.178), and secondary endpoints were not formally tested.[1]
At two years, follow-up was limited to treated participants. Of 83 evaluable participants, 56 (67.5%) had at least a 30% IPSS improvement without medical or surgical retreatment. Mean IPSS fell from 23.4 to 11.0 (n = 74), and Qmax rose from 8.9 to 19.0 mL/s (n = 65). Hematuria and urinary tract infection were the most common adverse events. Missing follow-up and the lack of a long-term concurrent control limit comparisons with other procedures. Favorable sexual-function findings do not establish zero ejaculatory risk or equivalence to more invasive surgery.[3]
References
1. Urotronic/FDA. Optilume BPH Catheter System: Instructions for Use, 1124-004 Rev A. PMA P220029, physician labeling. FDA-posted label.
2. Kaplan SA, Moss J, Freedman S, et al. "The PINNACLE study: a double-blind, randomized, sham-controlled study evaluating the Optilume BPH catheter system for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia." J Urol. 2023;210(3):500–9. doi:10.1097/JU.0000000000003568
3. Kaplan SA, Moss JL, Freedman SJ. Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study). Prostate Cancer Prostatic Dis. 2024;27(3):531-536. doi:10.1038/s41391-024-00833-z.
4. Goueli R, Badlani GH, Welliver C, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA guideline (2026). Part III: Procedural and surgical management. J Urol. 2026;216(2):161-170. doi:10.1097/JU.0000000000005099. Statement 50.