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Optilume BPH — Paclitaxel-Coated Balloon for LUTS Secondary to BPH

The Optilume BPH Catheter System (Laborie / Urotronic) is an FDA-approved drug-device combination in which balloon dilation of the prostatic urethra is followed by a paclitaxel-coated balloon, to treat lower urinary tract symptoms (LUTS) secondary to BPH. It pairs mechanical dilation with local antiproliferative drug delivery, intended to prevent the tissue recoil and re-narrowing that limited earlier balloon prostatoplasty.[1][2] For positioning against other minimally invasive surgical therapies (MISTs), TURP and HoLEP, see the BPH & Male LUTS chooser.

Optilume BPH and the Optilume urethral DCB are different devices. They share the paclitaxel-coated-balloon platform but have 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:

  1. Mechanical balloon dilation of the prostatic urethra opens the obstructed channel and creates an anterior commissurotomy.[1][2][5]
  2. Local paclitaxel delivery occurs during balloon inflation. Paclitaxel stabilizes microtubules and arrests dividing cells; limiting prostatic smooth-muscle and fibroblast proliferation to maintain patency is the proposed mechanism, but direct mechanistic evidence after Optilume BPH is lacking.[1][2][5]

The concept is analogous to drug-coated balloons used in vascular interventions and to the Optilume urethral DCB. Optilume BPH is not ablative, resective or implant-based, which distinguishes it mechanistically from Rezūm (thermal ablation), HoLEP, TURP and Aquablation (resection, enucleation and hydroablation), UroLift (implant) and PAE (embolization).[3]

Patient selection​

The AUA 2026 BPH guideline states that clinicians may offer the intraprostatic drug-coated balloon for prostates of 20–80 cc, a prostatic urethral length of 32–55 mm and no obstructing median lobe .[21] The US label indicates the device for obstructive symptoms from BPH in men 50 years or older and contraindicates it in patients with hypersensitivity to paclitaxel or structurally related compounds, an active urinary tract infection, an artificial urinary sphincter or a penile prosthesis.[23] Because paclitaxel was detectable in semen at 12 months in 1 of 3 evaluable men in the label's selected pharmacokinetic sample, the label advises abstinence or a condom for 30 days and highly effective contraception to avoid fathering a child for at least 12 months, with longer precautions by shared decision.[21][23]

Trial entry criteria were as follows[4][5]:

  • Men aged 50 years or older (PINNACLE: 50–80 years)
  • Moderate-to-severe LUTS secondary to BPH (PINNACLE: IPSS ≥ 13)
  • Prostate volume 20–80 g
  • Peak urinary flow rate (Qmax) 5–15 mL/s in EVEREST-I and 5–12 mL/s in PINNACLE[4][5]
  • Prostatic urethral length 35–55 mm in EVEREST-I and 32–55 mm in PINNACLE
  • PINNACLE excluded intravesical prostatic protrusion above 1 cm; 28/100 Optilume participants had some protrusion.[8]

Optilume BPH is an option when preservation of erectile and ejaculatory function is a priority, when an outpatient setting is desired, or when the patient wants a non-implant, non-ablative treatment.[3][6]

The AUA 2026 Conditional Recommendation (Grade C) applies to prostates 20–80 cc with a prostatic urethral length of 32–55 mm and no obstructing median lobe; PINNACLE enrolled men with prostate volumes of 20–80 g, while the US label does not list median-lobe obstruction as a contraindication.[21][5][23] PINNACLE compared the active arm at 12 months with the sham arm at 3 months; only the active arm continued follow-up beyond 1 year, while single-arm EVEREST-I follow-up reached 4 years.[5][8][22]

Procedure​

  • Setting: outpatient, in an ambulatory surgery center or the office. In PINNACLE, 84.7% of the active arm and 87.5% of the sham arm were treated under deep sedation or general anesthesia; the AUA guideline notes that local anesthesia is possible.[5][21]
  • Access: transurethral delivery under direct cystoscopic visualization.
  • Equipment and sizing: the kit holds one uncoated 90 Fr x 30 mm predilation balloon and one coated balloon of the same diameter, 30, 35, 40 or 45 mm long, chosen by transrectal-ultrasound prostatic urethral length (32 to 37, 37 to 42, 42 to 47 or above 47 mm, measured from the bladder-neck base, not the tip of an intravesical protrusion). A rigid cystoscope with at least a 19.5 Fr sheath is used, and each balloon is used side by side with the scope.[23]
  • Predilation: the uncoated balloon is positioned with its blue marker at the distal edge of the external sphincter and inflated slowly under traction until the anterior commissure separates, usually with a sudden pressure drop on the gauge. No more than 3 inflation cycles to rated burst pressure are used; if the commissurotomy is not achieved, the operator proceeds to the coated balloon. After complete dilation, deflate the predilation balloon and advance the cystoscope into the prostatic urethra to visually confirm the anterior commissurotomy before withdrawing the balloon.[23]
  • Drug delivery: handle the coated balloon with dry sterile gloves or dry gauze; do not immerse or wipe it before use, and replace it if wetted. Position it as above under cystoscopy, allowing about 1 minute for the coating to hydrate in the urethra before inflation. Inflate for at least 5 minutes (longer at the operator's discretion). Monitor the blue marker during inflation; if the balloon slips into the bladder, deflate and reposition it, and if it migrates distally toward the external sphincter, immediately stop inflation and reposition it. The prostatic urethra is not re-inspected with the cystoscope afterward, because irrigation may disturb the deposited coating.[23]
  • Catheterization: a Foley catheter is placed after the procedure. The label calls for a minimum of 2 days, with mild-to-moderate traction (a Foley balloon of at least 30 cc for about 30 minutes reduced hematuria in the trials). Mean catheterization was 3.0 days in the active arm and 2.5 days in the sham arm in PINNACLE.[5][23]

Clinical efficacy​

Three study programs make up the evidence base.

EVEREST-I (early feasibility, single-arm)​

Open-label, single-arm study of 80 men at 6 Latin American sites.[4][7]

OutcomeBaseline1 year2 years
IPSS22.37.98.2
Qmax (mL/s)10.918.417.2
≥ 40% IPSS responder rate—81%[4]—

PINNACLE (pivotal RCT)​

Prospective, double-blind, sham-controlled RCT of 148 men (100 active, 48 sham) randomized 2:1 at 18 U.S. and Canadian centers.[5] Blinding was maintained to 1 year, and follow-up beyond 1 year was limited to the active arm.[5][8] The primary comparison was 12-month improvement in the active arm against 3-month improvement in the sham arm, with a 25% super-superiority margin for the sham effect. The labeled analysis did not meet that endpoint (difference +1.4 points, 95% CI −1.6 to 4.5, p = 0.178), and the secondary endpoints were not formally tested. Twenty sham participants crossed over to active treatment before 12 months.[23]

OutcomeActive (1 yr)Sham (3 mo)Active (2 yr)
IPSS reduction−11.5 ± 7.8−8.0 ± 8.3−12.1 ± 8.0 (paired n = 74; IPSS 23.0 → 11.0)[8]
Qmax improvement+10.3 mL/s (+125%)[5]—+116.8%[8]
Symptomatic responder (≥ 30% IPSS Δ, no retreatment)——67.5% (56/83 with 2-year IPSS data or treatment failure)[8]
Sexual function (IIEF / MSHQ-EjD)preserved—preserved

No device- or treatment-related serious adverse events were reported beyond 12 months.[8]

EVEREST-I long-term follow-up​

In the cohort of 80 enrolled men, those assessed at 4 years had mean improvements of 12.1 IPSS points and 2.8 IPSS quality-of-life points (n=59 for each), and +5.6 mL/s in Qmax (n=53). No treatment-related adverse events were reported during long-term follow-up. The study was funded by the manufacturer and was single-arm.[22]

SUMMIT (real-world, multi-center)​

Prospective open-label study of 30 men at 5 Canadian centers.[6]

OutcomeBaseline12 months
IPSS23.510.8
Qmax (mL/s)8.714.7
Sexual function—no significant change

Safety profile​

The most common adverse events across studies were[4][5][6][8]:

  • Hematuria, the most frequent (40%, 39/98 in the PINNACLE active arm regardless of relatedness), usually self-limited[5]
  • Urinary tract infection (14%, 14/98 in the PINNACLE active arm regardless of relatedness)[5]
  • Dysuria (9.2%, 9/98 in the PINNACLE active arm regardless of relatedness)[5]
  • In the PINNACLE active arm (regardless of relatedness), urge or mixed incontinence (8.2%, 8/98), mild stress incontinence (7.1%, 7/98) and bladder spasms (6.1%, 6/98)[5]
  • Transient urinary retention

In PINNACLE these events were typically mild to moderate and resolved within 1 month.[5] In the label's as-treated analysis, treatment-related events included hematuria (39.8%; 41 events in 39 men, median 34 days to resolution, fewer after the traction protocol), urinary tract infection (11.2%), dysuria (8.2%), mild stress incontinence (7.1%), bladder spasm (6.1%) and urethral stricture (4.1%). Six men (6.1%) had treatment-related serious events (5 device-related, 1 procedure-related), most often post-procedural hematuria (4 events), and one grade 3 bladder perforation is listed. No participant met the composite of major device-related complications, and there were no grade 4 or 5 related events.[23] The PINNACLE report describes the five device-related serious events as four postprocedural hematuria events needing cystoscopic management or extended observation and one urethral false passage.[5] Complication rates in EVEREST-I were significantly affected by device diameter.[4] Systemic paclitaxel exposure was minimal in the PINNACLE pharmacokinetic subset (mean maximum plasma concentration 0.4 ng/mL).[5]

Sexual function preservation​

EVEREST-I, PINNACLE (1 and 2 years) and SUMMIT reported preserved group-level sexual-function questionnaire results.[4][5][6][8] In PINNACLE, ejaculatory dysfunction was reported as an adverse event in 4/98 treated men and 1/48 sham participants; no treatment-related de novo erectile dysfunction was reported.[5] Narrative reviews place it with UroLift and iTIND among the MISTs with the best sexual-function profiles, in contrast to TURP (retrograde ejaculation 60–75%, ED approximately 14%) and 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]

ProcedureIPSS Δ (mixed time points)Qmax Δ (mixed time points; see text)Volume rangeAnesthesiaMedian lobe
Optilume BPH−11.5 at 12 mo (ITT, 100 randomized)[5]+10.3 mL/s (82 paired at 12 mo)[5]20–80 gLocal / sedationSignificant median-lobe component (e.g., intravesical protrusion > 1 cm) excluded in PINNACLE; smaller protrusion included[8][25]
Rezūm−11.3+5.630–80 gLocal / sedationTreatable
UroLift (PUL)−11.0 at 1 mo[9]+4.3 at 1 mo[9]30–80 cc in the L.I.F.T. trial[15]; the US IFU (Rev B, 2020) excludes >100 cc[26]Local / sedationObstructing median lobe excluded in the L.I.F.T. trial[15]; the US IFU (Rev B, 2020) includes median-lobe hyperplasia[26]
iTIND−10.5+3.9up to ~ 75 gLocal / sedation—
Aquablation−15.1+10.330–150 gGeneral / regionalTreatable
PAE−11.6 to −14.5+6.1Any sizeLocal / sedationTreatable
TURP−15.1+10.6up to ~ 80 gGeneral / regionalTreatable

In PINNACLE, Qmax improved by +10.3 mL/s at 1 year.[5] The JAMA review reports +5.6 mL/s for Rezūm at 12 months, +4.3 mL/s for UroLift and +6.1 mL/s for PAE at 1 month, and +10.6 mL/s for TURP and +10.3 mL/s for Aquablation at 12 months[9]; EVEREST-I reported +5.6 mL/s at 4 years[22]. These cross-trial comparisons use different populations and, for UroLift and PAE, different time points.[5][9][10][22] The Cornu network meta-analysis, which did not include Optilume BPH or Aquablation, found that TURP gave the largest flow-rate improvement, while symptom scores and quality of life with PAE, PUL and WVTT were similar to TURP.[10]

Durability and retreatment​

ProcedureSurgical retreatmentFollow-up horizon
Optilume BPHSurgical reintervention: 3/100 (3%) by 2 yr in the PINNACLE treatment arm; 1/80 (1.3%) by 4 yr in single-arm EVEREST-I, conservatively counting a prostatectomy for refractory hematuria. PINNACLE's separate composite symptomatic responder rate was 56/83 (67.5%) at 2 yr.[8][22]2 yr (postrandomization treatment-arm follow-up), 4 yr (single-arm; 59/80 evaluable for symptom response)
Rezūm4.4% surgical retreatment at 5 yr[12]5 yr
UroLift~ 6% / yr in a systematic review; 5-yr surgical retreatment 22.3% in a US commercial-claims cohort of men aged 35–65[13][14][15]5 yr
Aquablation~ 4.1% at 5 yr[3]5 yr
PAERetreatment rate is higher than with TURP (RR 3.20 short term, 3.80 at 13–24 months)[16]1–2 yr
iTIND~ 10% at 24 mo[3]2 yr
TURPRanked first for lower reintervention in a 12-month network meta-analysis; comparative durability beyond 12 months was uncertain.[17]12 mo (network comparison)

A network meta-analysis of reintervention rates ranked TURP first at 12 months, followed by Aquablation, iTIND, Rezūm and UroLift. Optilume BPH was not included in that network meta-analysis.[17] An Italian Delphi consensus flagged a higher retreatment risk for UroLift and iTIND but not for Rezūm or Aquablation.[18]

Where Optilume BPH fits​

Optilume BPH differs from other MISTs in these ways[3][9]:

  • PINNACLE reported a 1-year Qmax improvement of +10.3 mL/s after Optilume BPH.[5]
  • Erectile and ejaculatory function did not change significantly across studies, as with UroLift, iTIND and Rezūm.
  • It is delivered as an outpatient procedure with no implant and no tissue resection.
  • Its mechanism (paclitaxel-coated balloon dilation) is neither ablative, resective nor implant-based.

Limitations:

  • Randomized data end at 1 year against sham. Uncontrolled follow-up reaches 4 years.
  • PINNACLE excluded a significant median-lobe component (e.g., intravesical prostatic protrusion above 1 cm); smaller protrusion was included.[8][25]
  • Prostate volume is limited to 20–80 g.
  • The AUA 2023 Guideline Amendment, whose evidence search ended in October 2022 before the pivotal trial was published, did not address the device. The 2026 guideline added a Conditional Recommendation (Grade C).[19][21]
  • EAU 2026 lists the paclitaxel-coated balloon among the non-ablative techniques under investigation and makes no recommendation, because randomized comparison with a reference technique is still needed. It reports a 40% or greater IPSS improvement in 75–81% of men at 3 months and notes that larger balloon diameters were associated with more bleeding and incontinence.[24]

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

21. Goueli R, Badlani GH, Welliver C, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline (2026). Statement 50, intraprostatic drug-coated balloon. American Urological Association; 2026.

22. Kaplan SA, Pichardo M, Rijo E, et al. Long-term outcomes after treatment with Optilume BPH: four-year results from the EVEREST study. Can Urol Assoc J. 2024;18(11):E319-E325. doi:10.5489/cuaj.8737

23. Urotronic. Optilume BPH Catheter System: Instructions for Use, 1124-004 Rev A (US). Checked September 26, 2026.

24. European Association of Urology. EAU Guidelines on the Management of Non-neurogenic Male LUTS. 2026 (March update). Official full guideline. See section 5.3.5.c.2.

25. U.S. Food and Drug Administration. Optilume BPH Catheter System (P220029): Summary of Safety and Effectiveness Data. 2023. FDA PDF.

26. NeoTract, Inc. UroLift System UL400 and UroLift ATC System: Instructions for Use (L00169-01 Rev B, US). February 2020. Manufacturer IFU.