Optilume BPH — Paclitaxel-Coated Balloon for LUTS Secondary to BPH
The Optilume BPH Catheter System (Laborie / Urotronic) is an FDA-approved minimally invasive drug-device combination that uses paclitaxel-coated balloon dilation of the prostatic urethra to treat lower urinary tract symptoms (LUTS) secondary to BPH. It pairs mechanical prostatic urethral dilation with local antiproliferative drug delivery to prevent the rapid tissue recoil and re-narrowing that limited earlier balloon prostatoplasty technologies.[1][2] For positioning vs other minimally invasive surgical therapies (MISTs) and TURP / HoLEP, see BPH & Male LUTS — chooser.
Optilume BPH and the Optilume urethral drug-coated balloon share the paclitaxel-coated-balloon platform but are distinct devices for distinct indications. Optilume BPH treats LUTS secondary to BPH at the prostatic urethra (PINNACLE, EVEREST-I, SUMMIT studies). The urethral DCB treats recurrent anterior urethral stricture (ROBUST trials) — see Drug-Coated Balloon Therapy.
Mechanism of action
The device combines two therapeutic principles:
- Mechanical balloon dilation of the prostatic urethra at the bladder neck and prostatic fossa, opening the obstructed channel and creating commissurotomy-like splits in the lateral lobes.[1][2]
- Local paclitaxel delivery during balloon inflation. Paclitaxel stabilizes microtubules and arrests dividing cells, inhibiting smooth-muscle and fibroblast proliferation that would otherwise drive re-stenosis and tissue recoil.[1][2]
The concept is analogous to drug-coated balloons used in vascular interventions and to the Optilume urethral DCB. Importantly, Optilume BPH is neither ablative, resective, nor implant-based, distinguishing it mechanistically from Rezūm (thermal ablation), HoLEP / TURP / Aquablation (resection / enucleation / hydroablation), UroLift (implant), and PAE (embolization).[3]
Patient selection
Based on pivotal trial criteria[4][5]:
- Men ≥ 50 years
- Moderate-to-severe LUTS secondary to BPH (IPSS ≥ 13)
- Prostate volume 20–80 g
- Peak urinary flow rate (Qmax) 5–15 mL/s
- Prostatic urethra length 30–55 mm
- No obstructing median lobe (current studies excluded median-lobe-dominant BPH)
Particularly attractive when sexual function preservation (erectile and ejaculatory) is a high priority, when an office or ambulatory setting is desired, or when the patient wants a non-implant, non-ablative option.[3][6]
Limitations of selection criteria. Median-lobe obstruction is currently a relative contraindication. Prostate volumes > 80 g are outside studied range. Long-term durability beyond 2 years is not yet established.
Procedure
- Setting: office-based or ambulatory; can be performed under local anesthesia or conscious sedation.[4][5]
- Access: transurethral catheter delivery under cystoscopic guidance.
- Dilation: the dual-lobe balloon is positioned across the prostatic urethra with the proximal balloon at the bladder neck. Sequential or simultaneous inflation creates controlled splits at 3 and 9 o'clock with concurrent paclitaxel transfer to the dilated tissue.[1][5]
- Catheterization: Foley catheter typically placed post-procedure for ~ 2–7 days.[5]
Clinical efficacy
Three principal study programs anchor the evidence base.
EVEREST-I (early feasibility, single-arm)
Open-label, single-arm study of 80 men at 6 Latin American sites.[4][7]
| Outcome | Baseline | 1 year | 2 years |
|---|---|---|---|
| IPSS | 22.3 | 7.9 | 8.2 |
| Qmax (mL/s) | 10.9 | 18.4 | 17.2 |
| ≥ 40% IPSS responder rate | — | 81% | sustained |
PINNACLE (pivotal RCT)
Prospective, double-blind, sham-controlled RCT of 148 men (100 active, 48 sham) at 18 U.S. / Canadian centers — the strongest evidence anchor.[5][8]
| Outcome | Active (1 yr) | Sham (3 mo) | Active (2 yr) |
|---|---|---|---|
| IPSS reduction | −11.5 ± 7.8 | −8.0 ± 8.3 | −12.4 (IPSS 23.4 → 11.0) |
| Qmax improvement | +10.3 mL/s (+125%) | — | +116.8% |
| Symptomatic responder (≥ 30% IPSS Δ, no retreatment) | — | — | 67.5% |
| Sexual function (IIEF / MSHQ-EjD) | preserved | — | preserved |
No device- or treatment-related serious adverse events were reported beyond 12 months.[8]
SUMMIT (real-world, multi-center)
Prospective open-label study of 30 men at 5 Canadian centers.[6]
| Outcome | Baseline | 12 months |
|---|---|---|
| IPSS | 23.5 | 10.8 |
| Qmax (mL/s) | 8.7 | 14.7 |
| Sexual function | — | no significant change |
Safety profile
The most common adverse events across studies[4][5][6][8]:
- Hematuria — most frequent; typically self-limited
- Urinary tract infection
- Dysuria
- Transient urinary retention
Adverse events are predominantly Clavien-Dindo Grade I–II and self-limited. Complication rates were influenced by device diameter in the EVEREST-I cohort.[4] No paclitaxel-related systemic toxicity has been reported.
Sexual function preservation
A defining attribute. Across EVEREST-I, PINNACLE 1- and 2-year, and SUMMIT, Optilume BPH demonstrated no significant deterioration in erectile (IIEF-EF) or ejaculatory (MSHQ-EjD) function.[4][5][6][8] This places it alongside UroLift and iTIND for the strongest sexual-function-preservation profiles among BPH MISTs, and is a key differentiator vs TURP (retrograde ejaculation 60–75%, ED ~ 14%) and from Aquablation (retrograde ejaculation 7–10%).[3][9]
Comparison with other MISTs
No head-to-head RCTs directly compare Optilume BPH with other MISTs; comparisons are indirect via narrative reviews and network meta-analyses.[3][9][10][11]
| Procedure | IPSS Δ (12 mo) | Qmax Δ (12 mo) | Volume range | Anesthesia | Median lobe |
|---|---|---|---|---|---|
| Optilume BPH | −11.5 to −12.4 | +10.3 mL/s | 20–80 g | Local / sedation | Excluded in trials |
| Rezūm | −11.3 | +5.6 | 30–80 g | Local / sedation | Treatable |
| UroLift (PUL) | −11.0 | +4.3 | < 80 g (no median lobe) | Local / sedation | Excluded in original label |
| iTIND | −10.5 | +3.9 | up to ~ 75 g | Local / sedation | — |
| Aquablation | −15.1 | +10.3 | 30–150 g | General / regional | Treatable |
| PAE | −11.6 to −14.5 | +6.1 | Any size | Local / sedation | Treatable |
| TURP | −15.1 | +10.6 | up to ~ 80 g | General / regional | Treatable |
Optilume BPH's Qmax improvement (+10.3 mL/s) is notably higher than other non-resective MISTs (UroLift, Rezūm, PAE typically +3–6 mL/s) and approaches TURP and Aquablation.[9][10] Network meta-analyses confirm that resective procedures still produce the strongest urinary-domain outcomes overall, but Optilume BPH narrows the gap among non-resective options.[10][11]
Durability and retreatment
| Procedure | Surgical retreatment | Follow-up horizon |
|---|---|---|
| Optilume BPH | 67.5% remained symptomatic responders at 2 yr (PINNACLE); longer data not yet available[8] | 2 yr |
| Rezūm | 4.4% surgical retreatment at 5 yr[12] | 5 yr |
| UroLift | ~ 6% / yr; 5-yr real-world ~ 22%[13][14][15] | 5 yr |
| Aquablation | ~ 4.1% at 5 yr[3] | 5 yr |
| PAE | 13–21% at 24 mo[16] | 2–3 yr |
| iTIND | ~ 10% at 24 mo[3] | 2 yr |
| TURP | Lowest retreatment of all options[17] | 5+ yr |
Network meta-analyses of reintervention rates rank TURP highest for durability, followed by Aquablation and Rezūm; Optilume BPH currently lacks 5-yr data needed for direct ranking.[17] An Italian Delphi consensus flagged higher retreatment risk for UroLift and iTIND but not Rezūm or Aquablation.[18]
Where Optilume BPH fits
Optilume BPH occupies a distinct niche among MISTs[3][9]:
- Qmax improvement comparable to resective procedures (TURP, Aquablation), unusual among non-resective MISTs.
- Sexual-function preservation profile of non-resective MISTs (UroLift, iTIND, Rezūm) — no significant change in erectile or ejaculatory function across studies.
- Office or ambulatory delivery under local anesthesia / conscious sedation, with no implant and no tissue resection.
- Mechanism distinct from every other MIST (paclitaxel-coated balloon dilation; neither ablative, resective, nor implant-based).
Principal limitations:
- No long-term data beyond 2 years.
- Median-lobe obstruction excluded from current trials.
- Prostate volume range 20–80 g (smaller and larger glands not yet studied).
- AUA 2023 Guideline Amendment was published before sufficient evidence accrual; positioning in the BPH treatment ladder will continue to evolve.[19]
Regulatory status
Optilume BPH is FDA-approved as a minimally invasive surgical therapy for LUTS due to BPH.[1] The same paclitaxel-coated balloon platform is FDA-approved for recurrent anterior urethral strictures under the ROBUST trial program — see Drug-Coated Balloon Therapy.[20]
References
1. Saffarzadeh M, Derigs M, Ren R, et al. Device profile of Optilume BPH catheter system for minimally invasive treatment of benign prostatic hyperplasia. Expert Rev Med Devices. 2025;1-11. doi:10.1080/17434440.2025.2553051
2. Te AE, Kaplan SA. Balloons in benign prostatic hyperplasia: will they float? A comprehensive review of prostatic balloon prostatoplasty. Urol Clin North Am. 2025;52(4):559-566. doi:10.1016/j.ucl.2025.07.007
3. Albayrak AT, Bulbul MV, Rubez A, Fregonesi A, Serefoglu EC. Sexual and urinary outcomes of minimally invasive surgical therapies for LUTS/BPH: a narrative review. Int J Impot Res. 2026. doi:10.1038/s41443-026-01271-2
4. Kaplan SA, Pichardo M, Rijo E, et al. One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis. 2021;24(4):1073-1079. doi:10.1038/s41391-021-00362-z
5. 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):500-509. doi:10.1097/JU.0000000000003568
6. Siqueira MHB, Buksh O, Hammoud A, et al. The SUMMIT study: a real-world, clinical study to evaluate the performance of the Optilume® BPH catheter system in men with symptomatic benign prostatic hyperplasia (BPH). Urology. 2026. doi:10.1016/j.urology.2026.04.009
7. Pichardo M, Rijo E, Espino G, et al. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol. 2023;41(8):2209-2215. doi:10.1007/s00345-023-04473-1
8. 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
9. Wei JT, Dauw CA, Brodsky CN. Lower urinary tract symptoms in men. JAMA. 2025;334(9):809-821. doi:10.1001/jama.2025.7045
10. Cornu JN, Zantek P, Burtt G, et al. Minimally invasive treatments for benign prostatic obstruction: a systematic review and network meta-analysis. Eur Urol. 2023;83(6):534-547. doi:10.1016/j.eururo.2023.02.028
11. Tanneru K, Jazayeri SB, Alam MU, et al. An indirect comparison of newer minimally invasive treatments for benign prostatic hyperplasia: a network meta-analysis model. J Endourol. 2021;35(4):409-416. doi:10.1089/end.2020.0739
12. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021;206(3):715-724. doi:10.1097/JU.0000000000001778
13. Miller LE, Chughtai B, Dornbier RA, McVary KT. Surgical reintervention rate after prostatic urethral lift: systematic review and meta-analysis involving over 2,000 patients. J Urol. 2020;204(5):1019-1026. doi:10.1097/JU.0000000000001132
14. Helman T, Patil D, Marthi S, Browne B. Impact of endoscopic bladder outlet procedures on medical and surgical retreatment: a large population analysis. J Endourol. 2025;39(6):608-616. doi:10.1089/end.2024.0741
15. Jung JH, Reddy B, McCutcheon KA, et al. Prostatic urethral lift for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database Syst Rev. 2019;5:CD012832. doi:10.1002/14651858.CD012832.pub2
16. Jung JH, McCutcheon KA, Borofsky M, et al. Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database Syst Rev. 2022;3:CD012867. doi:10.1002/14651858.CD012867.pub3
17. Shin BNH, Qu L, Rhee H, Chung E. Systematic review and network meta-analysis of re-intervention rates of new surgical interventions for benign prostatic hyperplasia. BJU Int. 2024;134(2):155-165. doi:10.1111/bju.16304
18. Passarelli F, Castellani D, Secco S, et al. Minimally invasive surgical techniques (MISTs) for benign prostatic hyperplasia: results from a Delphi consensus project to shed light on controversial topics. World J Urol. 2025;43(1):363. doi:10.1007/s00345-025-05727-w
19. Sandhu JS, Bixler BR, Dahm P, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. 2024;211(1):11-19. doi:10.1097/JU.0000000000003698
20. 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(4):866-875. doi:10.1097/JU.0000000000002346