UroLift — Prostatic Urethral Lift (PUL) for BPH
The UroLift system (Teleflex, originally NeoTract) is an FDA-cleared minimally invasive treatment for LUTS secondary to BPH that uses permanent nitinol–stainless-steel implants to mechanically retract obstructive prostatic lobes and widen the urethral lumen without cutting, heating, or removing tissue.[1][2][26] Among BPH MISTs it is the implant-based option. Rezūm is thermal, Aquablation uses hydroablation, Optilume BPH is a drug-coated balloon, iTIND is a temporary nitinol device, and TURP and HoLEP resect or enucleate tissue. The AUA 2026 guideline states that clinicians should offer PUL for prostates of 30 to 80 cc without an obstructing median lobe .[23] For positioning against other BPH options, see BPH & Male LUTS — chooser.
Mechanism of action
Each UroLift implant is a double-ended hook with three components[1]:
- Super-elastic nitinol capsular tab (anchors on the prostatic capsule)
- Polyethylene-terephthalate monofilament (transcapsular tether)
- Stainless-steel urethral end piece (anchors on the urethral surface)
The delivery device deploys a fine needle through the prostatic lobe; the capsular tab anchors on the outer prostatic capsule and the urethral piece on the urethral surface. Tensioning compresses the obstructing lobe away from the urethra, opening the lumen.[1] Unlike the other BPH MISTs, PUL is not ablative, resective or drug-eluting, and the implants are permanent.
Procedure
PUL can be performed under local anesthesia with oral or IV sedation; general or spinal anesthesia is also used.[1][3] The device precautions below follow the UL400/ATC IFU; UroLift 2 uses a single-patient handle with separate implant cartridges and a different deployment sequence.[24][37] Mean procedure time in L.I.F.T. was 66.2 ± 23.8 minutes.[4] The procedure has these steps:
- Perform preprocedure cystoscopy with a 20 Fr rigid cystoscope assembly using a 2.9 mm 0° telescope and visual obturator. Inspect the urethra and bladder, then locate the prostatic fossa from bladder neck to verumontanum before implant placement.[24]
- The implant delivery device is angled anterolaterally to compress the obstructive lobe.
- Typically, 4–6 implants are placed, with the number adapted to anatomy; the UL400/ATC IFU recommends a maximum of 10. For lateral lobes, position the tip in the anterior prostate at 2–3 or 9–10 o'clock and place implants at approximately 1 cm intervals along both lobes, generally paired left and right, starting 1.5 cm distal to the bladder neck. A multinational retrospective series of 102 men used a mean of 4.5 implants per case.[24][3]
- Between and after implant deployments, perform cystoscopy of the urethra and bladder to confirm the urethral opening and tissue apposition, check for implants in the bladder or extending into it from the bladder neck, assess the trigone and bladder for injury, and remove improperly placed or poorly apposed components if required.[24]
- Assess voiding before discharge when a voiding trial is planned; catheter placement follows the trial result or local protocol. In L.I.F.T., 68/100 men offered a voiding trial avoided a postoperative catheter.[4]
Device precautions (US UL400/ATC IFU)
The device should not be used with prostate volume >100 cc, urinary tract infection, current gross hematuria, incompetent-sphincter incontinence or a urethral condition preventing device passage; the IFU also warns against use with known nickel, titanium or stainless-steel allergy. For lateral-lobe placement, start 1.5 cm distal to the bladder neck and space implants approximately 1 cm apart. Deployment <1 cm from the bladder neck may expose an implant to the bladder and cause encrustation.[24] For median-lobe placement, the US UL400/ATC IFU warns against implanting the capsular tab posterior to the 4 and 8 o'clock positions on the prostatic capsule to avoid adjacent neurovascular and gastrointestinal structures.[24] If intravesical median-lobe tissue cannot be brought into the prostatic fossa, do not deploy an implant.[24]
Patient selection
The L.I.F.T. pivotal trial enrolled men who met these criteria[4]:
- Men ≥ 50 years in L.I.F.T.; the US UL400/ATC indication starts at age 45 years.[4][24]
- IPSS ≥ 13
- Qmax ≤ 12 mL/s in L.I.F.T.; BPH6 allowed ≤ 15 mL/s.[4][9]
- Prostate volume 30–80 mL in L.I.F.T.; the UroLift IFU indicates use through 100 cc.[4][24]
- PVR ≤ 250 mL and no urinary retention in L.I.F.T.[4]
In PULSAR, a prospective single-arm study of 52 catheter-dependent men after a failed voiding trial on an alpha-blocker, 38/52 were catheter-free at 12 months and eight underwent another BPH operation; obstructive median lobes and atonic bladders were excluded.[38] For catheter-dependent urinary retention attributed to BPH, the AUA 2026 guideline recommends resective technologies, taking comorbidities into account .[23]
Median lobe — the MedLift extension
The original L.I.F.T. trial excluded obstructive median lobes; the US UL400/ATC device indication includes median-lobe hyperplasia, while the AUA and EAU recommendations below remain narrower.[4][24][23][22] MedLift was a non-randomized cohort of 45 men with obstructive middle lobes, compared with historical L.I.F.T. results, and later observational reports describe feasibility in selected median-lobe anatomy. Their authors are affiliated with the manufacturer.[6][7] The AUA 2026 statement applies to prostates without an obstructing middle lobe, whereas the EAU 2026 recommendation requires no middle lobe, and EAU notes that data on obstructed or protruding middle lobes are limited.[23][22]
Clinical efficacy
L.I.F.T. — pivotal RCT
A total of 206 men were randomized 2:1 (PUL versus sham) at 19 North American / Australian centers[4][8]:
- 3-month primary endpoint (blinded): IPSS −11.1 (PUL) versus −5.9 (sham), p = 0.003, an 88% greater improvement.[4][8]
- 12-month paired results: IPSS from 22.13 to 11.52 (n = 123); Qmax +4.03 mL/s (n = 102).[41]
| Timepoint | IPSS Δ | QoL Δ | BPHII Δ | Qmax Δ |
|---|---|---|---|---|
| 3 mo | −11.1 (50%) | — | — | +4.4 mL/s[4][8] |
| 12 mo | −10.6 (47%; paired per-protocol) | — | — | +4.0 mL/s[8] |
| 24 mo | −9.1 (41%; paired per-protocol) | — | — | +4.2 mL/s[8] |
| 5 yr | −7.6 (36%; paired per-protocol, n = 72) | 50% | 52% | +3.5 mL/s (44%; paired n = 52)[8] |
In the treated cohort, IPSS improvement persisted but declined from 47% at 1 yr (123 paired observations) to 36% at 5 yr (72 paired observations) in the per-protocol analysis.[8] The EAU 2026 guideline reports 5-year improvement of 36% in IPSS, 50% in QoL and 44% in Qmax.[22] After the 3-month sham comparison the trial was uncontrolled.
BPH6 — PUL vs TURP RCT
80 men, 10 European centers, 24-month follow-up[9][10]:
- Both arms achieved significant IPSS improvement.
- TURP produced greater IPSS reduction and Qmax improvement.
- PUL was superior for quality of recovery and ejaculatory function preservation at 12 months (p < 0.01), and on the composite BPH6 responder endpoint.[9] The trial was non-blinded and small. In a 2026 network meta-analysis of 36 RCTs (4,851 men), PUL had higher 12-month PVR than bipolar TURP (mean difference 67.47 mL, 95% credible interval 11.02–125.79), while the MSHQ-EjD function score favored PUL over monopolar/bipolar TURP (mean difference 4.99 points, 95% credible interval 1.32–8.64); no statistically significant difference in ejaculatory bother was detected.[25]
Multinational real-world
A retrospective single-arm series of 102 men at 7 centers in 5 countries placed a mean of 4.5 implants. Among paired observations at 12 months, IPSS improved 52% (n = 51), QoL 53% (n = 43) and Qmax 51% (n = 41; each p < 0.001); four of the 102 men underwent TURP for insufficient improvement by 11 months.[3]
Sexual function preservation — PUL's strongest signal
Erectile and ejaculatory function are preserved after PUL in the trials and pooled analyses below.[4][8][11][12][13]
- The L.I.F.T. reports observed no de novo sustained erectile dysfunction adverse events through 5 years of follow-up.[4][8]
- The L.I.F.T. reports observed no de novo sustained ejaculatory dysfunction adverse events through 5 years of follow-up.[4][8]
- The Franco 2026 Eur Urol pooled MIST analysis, as corrected in a published corrigendum, reported anejaculation of 0% with PUL, Optilume and iTIND, 3% with Rezūm and 5% with TPLA.[11][28]
- In the Light 2021 Eur Urol network meta-analysis (48 papers, 33 RCTs, 5,159 patients, 16 interventions), PUL ranked highest for erectile function at 1, 6, 12 and 24 months versus monopolar TURP, and reached significance at 24 months (MD 3.63, 95% CrI 0.14–7.11). The authors noted that direct evidence is lacking.[12]
- In the Cahill 2026 systematic review and meta-analysis (77 studies, 11,477 patients), IIEF scores improved significantly after PUL and Rezūm. PUL improved both MSHQ-EjD function and bother scores, and Rezūm improved only the bother score.[13]
- In the combined MedLift and L.I.F.T. lateral-lobe dataset, ≥ 40% of sexually active men improved by the MCID for erectile function through 12 months.[6]
Safety profile
Adverse events in L.I.F.T. were typically mild and transient.[1][4][14] The Cochrane review (Jung 2019) found that PUL likely increases minor adverse events versus sham at 3 months (RR 1.69, 95% CI 1.33–2.16; moderate certainty) and was uncertain about major adverse events.[1]
Common adverse events are dysuria, hematuria, pelvic pain and urgency, which are mostly mild to moderate and resolve within 2 to 4 weeks (EAU 2026 lists hematuria 16–63%, dysuria 25–58%, pelvic pain 5–17.9%, urgency 7.1–10%, transient incontinence 3.6–16% and UTI 2.9–11%).[22] In L.I.F.T., 40/140 treated men received a catheter by site protocol; 68/100 of the others avoided catheterization after a voiding trial.[4] Participants returned to preoperative physical activity in a mean of 8.6 days.[8]
Real-world signal — FDA MAUDE database
MAUDE reports identify uncommon but potentially serious events, including hematoma and hematuria requiring hospitalization.[15] In Porto 2023, 23% of 226 UroLift reports and 7% of 358 Rezūm reports were classified as major.[15] The separate Weiss report likewise describes a selected reporting dataset.[16] MAUDE lacks exposure denominators and complete, verified event capture.
Retreatment and durability — the central limitation
Clinical trial data:
- L.I.F.T.: cumulative surgical retreatment for recurrent LUTS was 10.7% at 3 yr and 19/140 (13.6%) at 5 yr.[8][1] The five-year report also describes removal of encrusted implants in 10 men and prophylactic removal of exposed implants in three; isolated removal without additional implants or tissue resection was outside the recurrent-LUTS count.[8]
- BPH6: secondary treatment for recurrent LUTS occurred in 3/44 PUL patients (6.8%) versus 2/35 TURP patients (5.7%) by 1 yr[1][9] and in 6/44 (13.6%) versus 2/35 (5.7%) by 2 yr.[10] The endpoint included additional PUL, intradetrusor botulinum toxin, laser treatment, or TURP.[9][10]
Meta-analysis (Miller 2020 J Urol) of 11 studies and 2,016 patients[17]:
- The annual surgical reintervention rate was 6.0% per year (95% CI 3.0–8.9), and higher in studies with longer follow-up.[17]
- Among 153 surgical reinterventions, the most common types were TURP / laser (51%), repeat PUL (32.7%) and device explant (19.6%).[17]
Real-world data report higher retreatment:
| Source | Population / database | Retreatment finding |
|---|---|---|
| Helman 2025 J Endourol[18] | MarketScan, 10,938 commercially insured men across procedures (age at diagnosis 35–65 yr) | 5-yr surgical retreatment 22.3% for PUL (vs 7% HoLEP, 24.5% TUMT). 1-yr medical retreatment also higher after MIST vs traditional procedures (42.9% vs 27.3%) |
| Raizenne 2022[19] | NY / CA population study, 2,694 men (PUL, TUNA, TUMT) | 1-yr and 3-yr reoperation 5.5% and 14.9% after PUL, with no significant difference from TUNA or TUMT |
| Gaffney 2021[20] | Premier Healthcare, 175,150 men | PUL OR 1.78 for retreatment within 2 years vs TURP / photovaporization (p < 0.01) |
| Shin 2024 BJU Int NMA[21] | 12-month reintervention NMA of new BPH interventions | Ranking at 12 months: TURP, Aquablation, iTIND, Rezūm, then UroLift |
| Feiertag TriNetX analysis, as summarized in the AUA 2026 guideline[23] | Claims database | Cumulative re-procedure 5.1% at 1 yr and 16.1% at 4 yr, vs 7.5% after TURP and 7.8% after PVP at 4 yr. EAU 2026 cites the same 4-year figures and adds an annual reintervention rate of 6% per year (95% CI 3.0–8.9) in a systematic review of 11 studies[22] |
Guideline status
AUA 2026. Clinicians should offer PUL as an option for prostates of 30 to 80 cc without an obstructing median lobe .[23] Before PUL, clinicians should counsel that it implants permanent tines that may affect future procedures and future prostate imaging .[23] The 2023 amendment used the same volume and median-lobe criteria.[5]
EAU 2026. Offer PUL to men with LUTS/BPO who want to preserve ejaculatory function, with a prostate < 70 mL and no middle lobe . Advise that retreatment rates are higher after PUL than after TURP . EAU rates the higher retreatment risk as level 3 evidence and the inferiority to TURP at 24 months as level 1b.[22] See the BPH & Male LUTS chooser for the full 2026 AUA framework.
Comparison with other MISTs
| Procedure | Reported IPSS change | Reported Qmax change | Studied volume range | Median lobe evidence | Implant left? | Retreatment context |
|---|---|---|---|---|---|---|
| UroLift (PUL) | −11.1 at 3 mo (about 50%)[4] | +4.0 mL/s at 12 mo[4] | 30–80 mL in L.I.F.T.; IFU excludes >100 cc[4][24] | Selected MedLift median-lobe cohort; guideline restrictions above[6] | Permanent nitinol / steel implants[24] | 22.3% surgical retreatment at 5 yr (MarketScan)[18] |
| Rezūm | −11.3 at 3 mo (pivotal treatment arm)[29] | +5.6 mL/s at 12 mo (pivotal treatment arm)[29] | 30–80 mL in pivotal trial; US FDA indication 30–150 mL since 2025[29][40] | Treatable | None | 4.4% surgical retreatment at 5 yr (pivotal trial)[29] |
| iTIND | −9.3 at 12 mo (RCT)[33] / −13.7 at 12 mo (single-arm)[34] | +3.5 mL/s at 12 mo (RCT)[33] / 7.3 to 14.7 mL/s at 12 mo (single-arm)[34] | 25–75 mL (RCT)[33]; <75 mL (single-arm)[34] | Excluded | None (device removed) | 5% retreatment at 3 yr (EAU 2026)[22] |
| Optilume BPH | −11.5 at 1 yr[35] | +10.3 mL/s at 1 yr[35] | 20–80 g[35] | Intravesical protrusion above 1 cm excluded; smaller protrusion included[42] | None | Not yet 5-yr |
| Aquablation | −15.1 at 12 mo (WATER)[30] | +10.3 mL/s at 12 mo (WATER)[30] | 30–80 mL (WATER); 80–150 mL (WATER II)[30][31] | Treatable | None | 4.1% pooled reoperation at 5 yr (2 studies)[32] |
| TURP | −15.1 at 12 mo (WATER)[30] | +10.6 mL/s at 12 mo (WATER)[30] | up to 80 mL in WATER[30] | Treatable | None | 7.7% pooled reoperation at 5 yr (He 2023)[32] |
Where UroLift fits
Distinguishing advantages
- In L.I.F.T., 68/100 men offered a postoperative voiding trial avoided a catheter; 40/140 treated men received one by site protocol.[4]
- Erectile and ejaculatory function are preserved, with 5-year follow-up from L.I.F.T.
- It can be performed under local anesthesia in the office.
- The AUA 2026 guideline lists HoLEP, ThuLEP, PVP or PAE, not PUL, for patients at high bleeding risk or on anticoagulants.
- Obstructive median lobes have been treated in MedLift and later observational reports, but AUA and EAU recommendations exclude them.
- Quality of recovery was better than after TURP in BPH6, and return to activity averages about 9 days.
- Later TURP, laser vaporization, HoLEP and repeat PUL remain possible after PUL.[24][39] Retained clips can jam the morcellator during HoLEP; a three-patient technical series reported blade replacement in two cases and noted that remnant clips and sutures can be retrieved with a grasper.[39] UroLift implants can impair later prostate MRI quality.[27]
Principal limitations
- Five-year surgical retreatment of 22.3% in MarketScan, second only to TUMT (24.5%) among the procedures compared.[18]
- At 12 months, Qmax increased +4.0 mL/s in the L.I.F.T. PUL arm[4], +4.6 mL/s in a Rezūm pilot cohort[36], +10.3 mL/s in the PINNACLE Optilume BPH arm[35], and +10.3 mL/s with Aquablation versus +10.6 mL/s with TURP in WATER[30].[4][36][35][30]
- Permanent implants in the body (versus iTIND's reversible reshape-and-remove or Optilume's non-implant approach).
- Prostate size thresholds differ: L.I.F.T. enrolled men with 30–80 mL prostates[4]; the EAU guideline strongly recommends offering PUL to men interested in preserving ejaculation with prostates <70 mL and no middle lobe[22]; and the UroLift IFU contraindicates use above 100 cc.[24] For larger glands, consider Aquablation, Simple Prostatectomy, or PAE.[4][22][24]
- FDA MAUDE reports describe hematoma and hematuria requiring hospitalization.
- In paired per-protocol L.I.F.T. observations, IPSS improvement attenuated from 47% at 1 yr (n = 123) to 36% at 5 yr (n = 72).[8]
Imaging consideration for the reconstructive urologist
UroLift implants are visible on CT as paired metallic densities in the prostatic urethra and capsule. The stainless-steel urethral end piece creates MRI artifact. The US UL400/ATC IFU labels the implant MR Conditional for scanning at ≤3.0 T, a maximum spatial gradient of ≤1,500 Gauss/cm, and MR system-reported whole-body averaged SAR of ≤4 W/kg for 15 minutes per pulse sequence (First Level Controlled Operating Mode).[24] In a single-center retrospective study of 37 patients, all had artifact, which affected diffusion-weighted images more than T2-weighted images; artifact obscured a mean 32% of the gland on diffusion-weighted images, and 16–24% of examinations had suboptimal image quality.[27] Men who may need prostate MRI for cancer workup should be counseled about this limitation before implantation.[23][27]
See Also
BPH & Male LUTS — chooser · Rezūm · iTIND · Optilume BPH · Prostate Artery Embolization · Simple Prostatectomy · Prostate Enucleation / HoLEP · UroLift device profile
References
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35. Kaplan SA, 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
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