L.I.F.T.: Prostatic Urethral Lift Versus Sham for BPH-Related Lower Urinary Tract Symptoms
L.I.F.T. was a multicenter, blinded, sham-controlled randomized trial of the prostatic urethral lift (UroLift) in 206 men aged 50 years or older with bothersome lower urinary tract symptoms (LUTS) from BPH, prostates of 30 to 80 cc and no obstructive median lobe, with the change in AUA symptom index (AUASI) at 3 months as the primary endpoint. The AUASI fell 11.1 points after the lift and 5.9 points after sham (P = 0.003).[1]
- Design and population
- Multicenter, sham-controlled, blinded randomized device trial. Men aged 50 years or older with AUASI of 13 or higher, Qmax of 12 mL/s or less and prostate volume of 30 to 80 cc, without an obstructive median lobe.
- Arms
- Prostatic urethral lift (UroLift) versus sham rigid cystoscopy with simulated lift sounds
- Report and follow-up
- 2013 · 3-month blinded comparison; lift arm followed to 12 months
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| 3-month change in AUA symptom index (reduction from baseline), intention to treat | −11.1 points vs −5.9 points | difference -5.2; CI -7.44–-2.96; P 0.003 | Met |
| 3-month change in IPSS quality-of-life item (reduction from baseline) | −2.2 points vs −1.0 points | difference -1.2; CI -1.67–-0.73; P <0.001 | Met |
| 3-month change in peak urinary flow rate | +4.28 mL/s vs +1.98 mL/s | difference 2.3; P 0.005 | Met |
| AUASI in the lift arm over 12 months (no sham comparison after 3 months) | 22.1 at baseline; 18.0 at 2 weeks; 11.0 at 3 months; 11.1 at 12 months | P <0.001 | Descriptive |
| Increase in Qmax in the lift arm | +4.4 mL/s at 3 months; +4.0 mL/s at 12 months | P <0.001 | Descriptive |
Harms: De novo erectile or ejaculatory dysfunction: None reported; Subjects with a related adverse event, months 0-3: 113/140 (80.7%); Catheterization for failed voiding trial: 32/100 (32%)
Design
Nineteen centers in the United States, Canada and Australia enrolled 206 men between February and December 2011. Entry required an AUASI of 13 or higher, a Qmax of 12 mL/s or less on a voided volume of at least 125 mL, and a prostate volume of 30 to 80 cc on transrectal ultrasound.[2][3] Of 430 men assessed, 23 (5.3%) were excluded for an obstructive median lobe, judged at cystoscopy.[2] Other exclusions included urinary retention, a post-void residual above 250 mL, a prior BPH procedure, urethral stricture, meatal stenosis or bladder neck contracture, prior pelvic surgery or irradiation, neurogenic bladder, sphincteric incontinence, and a history of prostate or bladder cancer.[3] Alpha-blockers were stopped 2 weeks, 5-alpha-reductase inhibitors 3 months and anticoagulants 3 days before treatment.[2]
Randomization was 2:1, in permuted blocks just before treatment, to the lift (140 men) or sham (66 men). The sham was rigid cystoscopy with sounds that mimicked the lift, including the surgeon calling for devices and deploying, but not inserting, a disposable biopsy device; a barrier blocked the patient's view below the waist. Patient and assessor, usually a research coordinator who had not taken part in the procedure, were blinded through the 3-month endpoint, and the blind was tested.[2][3] Uroflow tracings were over-read by an independent central reviewer using the 2-second rule, and an independent clinical events committee adjudicated adverse events. After 3 months all men were unblinded, and 53 of the 66 sham men (80%) later enrolled in a crossover study reported separately.[2] Follow-up analyses were by intention to treat, with the last observation carried forward, and per protocol, which censored men who had another BPH procedure, took BPH medication or had a protocol deviation.[2]
For every North American investigator, the trial cases were the first lift procedures they performed; there was no run-in.[2] In the per-protocol baseline table (137 lift and 64 sham men, one site's subjects excluded), mean age was 67 versus 64 years and mean AUASI 22.3 versus 24.6.[3]
Results
The AUASI fell 11.1 points (SD 7.67) with the lift and 5.9 points (SD 7.66) with sham, a difference of 5.2 points (95% CI 2.96 to 7.44; P = 0.003); the primary endpoint was met.[1][4] The IPSS quality-of-life item improved by 2.2 versus 1.0 points (P < 0.001), and Qmax rose 4.28 versus 1.98 mL/s (P = 0.005).[2] In the lift arm the AUASI fell from 22.1 at baseline to 18.0 at 2 weeks, 11.0 at 3 months and 11.1 at 12 months, and Qmax was 4.0 mL/s higher than baseline at 12 months.[1] Mean sexual function scores did not differ between arms at 3 months.[2]
After the 3-month comparison the trial followed the lift arm without a control group. Per-protocol results:[2][3]
| Follow-up | Paired men (IPSS) | IPSS change | Qmax change (paired men) |
|---|---|---|---|
| 3 months | 136 | −11.14 (−49.7%) | +4.29 mL/s (+64.4%), n = 122 |
| 12 months | 123 | −10.61 (−47.4%) | +4.03 mL/s (+58.5%), n = 102 |
| 24 months | 103 | −9.13 (−41.4%) | +4.21 mL/s (+58.6%), n = 86 |
| 36 months | 93 | −8.83 (−41.1%) | +3.47 mL/s (+53.1%), n = 69 |
| 48 months | 78 | −8.81 (−40.6%) | +4.27 mL/s (+63.4%), n = 60 |
| 60 months | 72 | −7.56 (−35.9%) | +3.48 mL/s (+44.3%), n = 52 |
At 5 years, 104 of 140 lift men (74.3%) were available; 18 (12.9%) were lost to follow-up, 9 (6.4%) had died of unrelated causes and 9 (6.4%) had exited. The per-protocol IPSS quality-of-life item had improved 50.3% and the BPH Impact Index 51.8%; by intention to treat the IPSS had fallen 7.85 points (35.0%). Some satisfaction with urinary symptoms (quality-of-life item of 3 or lower) was reported by 82%, and of the 18% who were dissatisfied, 10 men (77%) had entered with an IPSS of 20 or higher.[2]
Surgical retreatment for failure to cure reached 15 of 140 men (10.7%) at 3 years and 19 of 140 (13.6%) at 5 years. At 5 years, 6 men (4.3%) had received additional lift implants and 13 (9.3%) had TURP or laser ablation, including the four who left the study for TURP; 18 of the 19 retreated men had entered with an IPSS of 20 or higher.[3][2]
In the sexual function analysis, SHIM and MSHQ-EjD scores did not differ from sham at 3 months and were modestly improved from baseline at 1 year; ejaculatory bother improved most (40% over baseline), and no man had de novo sustained anejaculation or erectile dysfunction.[5] At 5 years, per-protocol IIEF-5 averaged 16.45 against 16.82 at baseline (P = 0.60, n = 49) and the MSHQ-EjD function score 9.53 against 9.22 (P = 0.096).[2]
Surgery and treatment delivery
After rigid cystoscopy, the delivery device, housing a 2.9 mm telescope, is passed through a 20 F sheath and angled laterally, usually toward the 10 and 2 o'clock positions, to compress the anterior third of the obstructing lobe. A 19-gauge needle is deployed laterally through the lobe; as it is withdrawn, the capsular tab of the implant seats against the prostatic capsule. The monofilament is then tensioned, cut to the width of the compressed lobe and secured by the urethral end-piece, so that each implant is sized in situ. The aim is a continuous channel through the anterior prostatic fossa.[2]
In North America the procedure was done under local anesthesia in every case but one (99.4%).[1][2] Men received a mean of 4.9 implants (range 2 to 11); four was the most common number (42%) and 85% received six or fewer.[2] Implant number did not correlate with prostate volume, prostate length or symptom response.[2][3] In the per-protocol set, procedure time was 66.2 minutes (SD 24.1) for the lift and 46.9 minutes (SD 17.4) for sham.[3] Forty of 140 lift men were catheterized routinely; among the other 100, 32 required catheterization after a failed voiding trial.[1] Mean catheter duration across the full lift cohort was 0.9 days, and men returned to preoperative activity in a mean of 8.6 days (SD 7.5).[2]
The authors recommend placing implants 1.5 cm from the bladder neck. An implant exposed to the bladder is removed endoscopically with graspers; on independent review of 1-year video cystoscopy, no properly deployed implant was encrusted and 2.1% of implants had been deployed too proximally.[2]
Adverse events
In the first 3 months 100 of 140 lift men (71.4%) had at least one related adverse event (162 events). The most frequent were hematuria, dysuria, pelvic pain, urgency and urge incontinence, typically mild to moderate and transient. Related events then became uncommon: 12 men between months 4 and 12, 6 between months 13 and 24, 2 between months 25 and 36, 2 between months 37 and 48 and 1 between months 49 and 60.[2]
By 5 years, 13 men (9.3%) had implants removed: 10 had encrusted implants that had been deployed too proximally and 3 had exposed, unencrusted implants removed prophylactically. At 3 years the report described one man with encrustation who developed urosepsis, which resolved.[2][3] Other genitourinary interventions through 3 years were one stricture dilation, one removal of bladder stones unrelated to the implants, two radical prostatectomies for unrelated prostate cancer and one bladder neck resection during ureteroscopic lithotripsy; the prostatectomies were done routinely with intact dissection planes.[3][2] By 5 years 15 men (10.7%) were taking a BPH medication.[2]
Limitations
The blinded comparison with sham lasted 3 months. Everything later is uncontrolled follow-up of the lift arm, after 80% of the sham men crossed over, and per-protocol results at 5 years rest on 72 paired IPSS observations in men who had not had another procedure or taken BPH medication.[2] The per-protocol baseline AUASI was higher in the sham arm (24.6 versus 22.3).[3] The trial excluded prostates outside 30 to 80 cc, obstructive median lobes, retention and a post-void residual above 250 mL.[3] Three authors are clinical training consultants for NeoTract, the device manufacturer.[2]
In conversation
- Parallel to Rezūm II (2015). Sham-controlled pivotal trial of another office MIST in 30–80 cc prostates; the final Rezūm report cites L.I.F.T.'s 13.6% five-year surgical retreatment.
Same setting PINNACLE (2023)
L.I.F.T. compared the lift with sham, not with resection. BPH6 randomized 80 men at 10 European centers to the lift or TURP; symptom relief was significant in both arms, and the lift was superior on the composite BPH6 responder endpoint, quality of recovery and ejaculation preservation at 12 months, in a small trial without participant blinding.[6] The EAU summary of evidence grades the lift's IPSS, Qmax and quality-of-life improvements as inferior to TURP at 24 months (level 1b) and cites a real-world analysis of more than 50,000 patients with a 16.1% reintervention rate at 4 years after UroLift, against 7.5% after TURP and 7.8% after photoselective vaporization; L.I.F.T. reported 13.6% at 5 years.[7]
Guidelines and approvals
- AUA 2026. Clinicians should offer the prostatic urethral lift as an option for patients with prostates of 30 to 80 cc without an obstructing median lobe , and should counsel that it implants permanent tines that may affect future procedures and prostate imaging .[4]
- EAU 2026. Offer the prostatic urethral lift to men with LUTS and benign prostatic obstruction who want to preserve ejaculatory function, with prostates under 70 mL and no middle lobe ; advise patients that retreatment rates are higher than after TURP .[7]
- FDA (September 13, 2013). The UroLift System received De Novo classification as an implantable transprostatic tissue retractor system (DEN130023).[8]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2013-06-11 | Randomized sham-controlled report · primary | — | 3-month change in AUA symptom index (reduction from baseline), intention to treat: −11.1 points vs −5.9 points; difference -5.2; CI -7.44–-2.96; P 0.003 Met 3-month change in IPSS quality-of-life item (reduction from baseline): −2.2 points vs −1.0 points; difference -1.2; CI -1.67–-0.73; P <0.001 Met 3-month change in peak urinary flow rate: +4.28 mL/s vs +1.98 mL/s; difference 2.3; P 0.005 Met AUASI in the lift arm over 12 months (no sham comparison after 3 months): 22.1 at baseline; 18.0 at 2 weeks; 11.0 at 3 months; 11.1 at 12 months; P <0.001 Descriptive Increase in Qmax in the lift arm: +4.4 mL/s at 3 months; +4.0 mL/s at 12 months; P <0.001 Descriptive | Roehrborn CG, Gange SN, Shore ND, et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. study. *J Urol.* 2013;190(6):2161-2167. doi:10.1016/j.juro.2013.05.116 DOI |
| 2013-09-30 | Sexual function analysis · secondary | — | 3-month erectile (SHIM) and ejaculatory (MSHQ-EjD) scores, lift versus sham: Scores did not differ from sham at 3 months; men with baseline SHIM below 5 were censored from the primary sexual function analysis.; — 12-month scores versus baseline in the lift arm: Modestly improved and statistically different from baseline at 1 year. Ejaculatory bother score improved most (40% over baseline).; — 12-month SHIM versus baseline in men entering with severe erectile dysfunction: Secondary stratified analysis by baseline erectile dysfunction severity.; P 0.016 | McVary KT, Gange SN, Shore ND, et al. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. *J Sex Med.* 2014;11(1):279-287. doi:10.1111/jsm.12333 DOI |
| 2015 | 3-year report · updated | — | 36-month change in IPSS, lift arm, per protocol (paired n=93): −8.83 points (−41.1%) from 21.56 to 12.73; P <0.0001 36-month change in IPSS quality-of-life item, lift arm, per protocol (n=93): −2.25 points (−48.8%) from 4.47 to 2.23; P <0.0001 36-month change in Qmax, lift arm, per protocol (n=69): +3.47 mL/s (+53.1%) from 8.32 to 11.79 mL/s; P <0.0001 Cumulative surgical retreatment for LUTS by 3 years: 15/140 (10.7%); — | Roehrborn CG, Rukstalis DB, Barkin J, et al. Three year results of the prostatic urethral L.I.F.T. study. *Can J Urol.* 2015;22(3):7772-7782. PMID 26068624 |
| 2017 | 5-year report · updated | — | 60-month change in IPSS, lift arm, per protocol (paired n=72): −7.56 points (−35.9%) from 21.47 to 13.92; P <0.0001 60-month change in IPSS quality-of-life item, lift arm, per protocol (n=72): −2.32 points (−50.3%) from 4.51 to 2.19; P <0.0001 60-month change in Qmax, lift arm, per protocol (n=52): +3.48 mL/s (+44.3%) from 8.52 to 12.00 mL/s; P <0.0001 60-month change in BPH Impact Index, lift arm, per protocol (n=71): −3.48 points (−51.8%) from 6.42 to 2.94; P <0.0001 Per-protocol change in IPSS from baseline by follow-up time, lift arm: −11.14 (−49.7%) at 3 months, n=136; −10.61 (−47.4%) at 12 months, n=123; −9.13 (−41.4%) at 24 months, n=103; −8.83 (−41.1%) at 36 months, n=93; −8.81 (−40.6%) at 48 months, n=78; −7.56 (−35.9%) at 60 months, n=72; — Descriptive Per-protocol change in Qmax from baseline by follow-up time, lift arm: +4.29 mL/s (+64.4%) at 3 months, n=122; +4.03 (+58.5%) at 12 months, n=102; +4.21 (+58.6%) at 24 months, n=86; +3.47 (+53.1%) at 36 months, n=69; +4.27 (+63.4%) at 48 months, n=60; +3.48 (+44.3%) at 60 months, n=52; — Descriptive Share of men reporting some satisfaction with urinary symptoms at 5 years (IPSS quality-of-life item of 3 or lower): 82%; — Descriptive Cumulative surgical retreatment for failure to cure by 5 years: 19/140 (13.6%); — 60-month IIEF-5, lift arm, per protocol (n=49): 16.45 versus 16.82 at baseline; P 0.6026 60-month MSHQ-EjD function score, lift arm, per protocol (n=49): 9.53 versus 9.22 at baseline; P 0.0962 | Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. *Can J Urol.* 2017;24(3):8802-8813. PMID 28646935 |
References
1. Roehrborn CG, Gange SN, Shore ND, et al. "The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. study." J Urol. 2013;190(6):2161-2167. doi:10.1016/j.juro.2013.05.116
2. Roehrborn CG, Barkin J, Gange SN, et al. "Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study." Can J Urol. 2017;24(3):8802-8813. PMID 28646935
3. Roehrborn CG, Rukstalis DB, Barkin J, et al. "Three year results of the prostatic urethral L.I.F.T. study." Can J Urol. 2015;22(3):7772-7782. PMID 26068624
4. Goueli R, Badlani GH, Welliver C, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. American Urological Association; approved April 2026. Statements 44 and 45.
5. McVary KT, Gange SN, Shore ND, et al. "Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift." J Sex Med. 2014;11(1):279-287. doi:10.1111/jsm.12333
6. Sønksen J, Barber NJ, Speakman MJ, et al. "Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study." Eur Urol. 2015;68(4):643-652. doi:10.1016/j.eururo.2015.04.024
7. Cornu JN, Elterman D, Hashim H, et al. EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS). Arnhem: EAU Guidelines Office; March 2026. Section 5.3.5.a.
8. U.S. Food and Drug Administration. De Novo classification DEN130023, UroLift System. Decision granted September 13, 2013.