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iTIND — Temporary Implantable Nitinol Device for BPH

The iTIND (Olympus / Medi-Tate) is an FDA-cleared minimally invasive treatment for symptoms of urinary outflow obstruction secondary to BPH in men aged 50 years or older; it temporarily reshapes the prostatic urethra and bladder neck over 5–7 days, after which the device is removed, leaving no permanent implant.[1][3][27] Unlike other MISTs, it does not ablate or resect tissue, release a drug or leave an implant. For other MISTs and for TURP or HoLEP, see BPH & Male LUTS — chooser.

Mechanism of action​

The iTIND is a self-expanding nitinol (nickel–titanium alloy) device with three elongated struts. Once deployed at the bladder neck and prostatic urethra, sustained radial force at the strut–tissue interface is described as causing ischemic necrosis and longitudinal incisions at 12, 5 and 7 o'clock.[11] Over 5–7 days these incisions remodel the urethral lumen. The device is then retrieved, leaving the widened channels but no foreign material.[3][4]

This "reshape-and-retrieve" mechanism differs from:

  • Rezūm (convective thermal ablation of transition zone)
  • HoLEP / TURP / Aquablation (enucleation / resection / hydroablation)
  • UroLift (permanent suture-tack implants holding lateral lobes apart)
  • Optilume BPH (paclitaxel-coated balloon dilation)
  • PAE (selective embolization-induced infarction)

Device evolution​

  • First-generation TIND (Porpiglia 2015, n = 32): demonstrated feasibility, with a 45% IPSS reduction and 67% Qmax improvement at 12 months. Four complications (12.5%) occurred, including one prostatic abscess and one urinary retention.[5]
  • Second-generation iTIND: the pivotal RCT and the multicenter studies used this device rather than the first-generation TIND.[1][6][7] No comparison of the two generations is reported.

Procedure​

Placement was performed under light sedation in MT-02; the current IFU directs intraurethral anesthetic gel and prophylactic antibiotics per local practice, leaves other anesthesia to clinician discretion, and does not recommend spinal anesthesia.[7][21] Mean operative time was 5.8 minutes in the first-generation study.[5][6]

  1. In MT-06, the compressed device was delivered through a 22 Fr rigid cystoscope; the current IFU also permits a rigid scope of at least 19 Fr or an access sheath with an inner lumen of at least 12 Fr and a positioning scope of at least 15.5 Fr. Advance the device until it expands in the bladder.[8][21]
  2. Before pullback, rotate the blue guidewire line to 12 o'clock and the anchoring leaflet to 6 o'clock; then seat the leaflet snugly at the bladder neck and confirm that the struts bear at 12, 5 and 7 o'clock without holding the external sphincter open.[11][21]
  3. Same-day discharge without an indwelling catheter was reported in MT-02, although eight of 81 men developed acute urinary retention while the device was in place or after retrieval. Tape the retrieval suture loosely to the penis with slack and instruct the patient not to pull or cut it during the in-situ period.[6][11][21]
  4. At 5–7 days, collapse and remove the device in an outpatient setting with topical or local anesthesia using the retrieval suture and snare through a suitable sheath, such as an open-ended Foley of at least 22 Fr or the US 20 Fr removal kit. If the suture breaks and cannot be extended, use a rigid cystoscope of at least 19 Fr and a grasper to remove the device through the sheath.[6][8][21]
  5. Patients returned to daily life on average 4.3 days after retrieval in MT-06.[8]

Patient selection​

Selection follows the trial entry criteria and the AUA 2026 guideline[9]:

  • Age 50 years or older.[1]
  • IPSS ≥ 10 and Qmax ≤ 12 mL/s (the MT-02 two-year report specifies Qmax < 12 mL/s).[6][7]
  • AUA 2026 says clinicians may offer TIPD for prostates of 25–75 mL without an obstructing median lobe .[9] MT-06 permitted volumes <120 mL, but the first 70 participants in its 6-month interim report had measured volumes of 15–80 mL.[8][9]
  • No obstructing median lobe. A median lobe was the only significant baseline predictor of iTIND failure in MT-02 (p < 0.0001).[7]
  • PVR ≤ 250 mL (trial exclusion criterion).[6][7]
  • Manufacturer contraindications include active UTI or prostatitis, an artificial urinary sphincter or other urethral implant, prostate or bladder cancer, bladder atonia or neurogenic dysfunction as the sole cause of symptoms, and non-BPH obstruction such as urethral stricture. The manufacturer warns against use in patients with a known nickel allergy and advises weighing benefits against risks in patients with coagulation disorders, compromised immunity, or impaired healing. MT-02 excluded patients unable to interrupt antithrombotic or antiplatelet therapy.[18][7][21]

A 2026 systematic review and expert-guidance paper on the median-lobe scenario concludes that iTIND and Optilume should not be offered to patients with a significant median lobe, because the studies consistently excluded them.[10]

Clinical efficacy​

MT-02: prospective multicenter single-arm study​

MT-02 enrolled 81 men across international centers (67 followed at 1 year, 51 at 2 years and 50 at 3 years)[6][7][11]:

TimepointIPSSQmax (mL/s)QoL
Baseline22.57.34.0
1 month11.7 (−46.3%)11.2 (+79.4%)—[11]
12 months8.8 (−59.1%)14.9 (+111.7%)1.6[11]
24 months8.5 (−56.7%)16.0 (+130.8%)1.8[11]
36 months8.6 (−58%)15.2 (+115%)1.8[11]

Among the 50 men observed at 36 months, improvement persisted; the 81-patient intention-to-treat analysis using last observation carried forward yielded a mean IPSS of 12.05 and Qmax of 13.43 mL/s at 36 months.[11] No late complications and no additional treatment failures were reported between 24 and 36 months.[11] Sexual and ejaculatory function were assessed with two yes/no questions.[7][11]

Pivotal RCT (NCT02506465): Chughtai 2021​

The trial used 2:1 allocation to randomize 185 men (128 assigned to iTIND, 57 to sham); 175 underwent the assigned procedure (118 iTIND, 57 sham)[1][21]:

  • Three-month responder analysis: 78.6% of assessed iTIND patients versus 60% of assessed sham patients achieved an IPSS reduction of at least 3 points (p = 0.03); the prespecified three-month co-primary comparison of mean IPSS change versus sham was not statistically significant (p = 0.104).[1][21]
  • 12 mo: IPSS fell by 9.25 points and Qmax rose by 3.5 mL/s, both p < 0.0001 versus baseline.[1] Unblinding occurred at 3 months, so the 12-month results are uncontrolled.
  • Adverse events occurred in 38.1% of treated iTIND patients and 17.5% of sham patients; most were mild and transient, but five procedure- or device-related serious adverse events occurred in three iTIND patients (retention twice, UTI twice and sepsis once).[1][21]

MT-06: prospective multicenter study​

The 6-month interim report includes the first 70 men, with broader inclusion (prostate volume < 120 mL)[8]:

  • IPSS, QoL and Qmax improved significantly at 6 months (p < 0.0001).
  • Sexual function and urinary continence were preserved in all subjects on the ISI, SHIM and MSHQ-EjD questionnaires.

Safety profile​

Most reported adverse events after iTIND were mild and transient, but MT-02's Table 2 includes grade IIIa and IIIb events.[1][6][7][11]

  • MT-02 Table 2 classifies acute urinary retention in 8/81 men (9.9%) and five failed initial voiding trials as grade IIIa; it lists two early and five later secondary TURP/laser events as grade IIIb. The article's prose inconsistently describes perioperative complications as grade I–II.[11]
  • Mean perioperative pain VAS score was 3.2 ± 1.6.[7]
  • No late postoperative complications were reported between 12 and 36 months.[11]

Sexual function preservation​

Sexual function preservation is the main functional attribute of iTIND[1][8][11][12]:

  • No de novo erectile or ejaculatory dysfunction occurred in the RCT.
  • MT-02 reported no de novo sexual or ejaculatory dysfunction through 3 years, assessed with yes/no questions.
  • A dedicated sexual-function analysis of the RCT (Elterman 2023) found no SHIM or total-IIEF difference between iTIND and sham at 3 months, or in the iTIND arm at 12 months compared with baseline. Men without baseline ED had a +6.07-point IIEF improvement at 12 months (p = 0.034) and improved ejaculatory function.[12]
  • A pooled analysis of MISTs (Franco 2026, as corrected) reported anejaculation of 0% with iTIND, UroLift and Optilume, 3% with Rezūm and 5% with TPLA.[13][20]
  • The narrative review lists 0% retrograde ejaculation with iTIND in its comparison table, but its abstract inconsistently states 4%; its text reports 4% for retreatment.[14]

Retreatment and durability​

Retreatment estimates depend on patient selection and on whether medication use is counted. In a retrospective seven-center cohort of 138 men (median prostate volume 30 mL), surgical retreatment was 16.7% and pharmacologic retreatment was 37.7% at two years.[19]

  • MT-02: of 51 patients followed to 24 months, 5 required surgery between 12 and 24 months. Four of the 5 had median lobes and were protocol deviators.[7]
  • At 12 months in MT-02, 2.4% had required medical therapy and 2.4% TURP; 12.3% were lost to follow-up.[6]
  • No additional treatment failures were reported between 24 and 36 months.[11] In later MT-02 follow-up, 50 of 81 men at three of nine sites continued; 41 had a single telephone assessment at 50–79 months, with mean IPSS 11.26 (45.3% below baseline).[29] Two men underwent surgery between 36 and 48 months.[29]
  • EAU 2026 cites a 5% three-year retreatment figure.[17] Its underlying systematic review reports up to 5% surgical or minimally invasive retreatment and up to 7% pharmacologic retreatment at three years, with unclear to high risk of bias in most studies.[33] EAU lists iTIND under investigation, makes no recommendation for it, and notes that randomized trials against a reference technique are ongoing.[17][33]
  • An Italian Delphi consensus of 28 urologists (Passarelli 2025) rated iTIND, UroLift and TPLA as carrying a high risk of retreatment, and Rezūm and Aquablation as not.[15]
  • A 2025 device-profile review states that available data suggest a higher retreatment rate than traditional surgery, and describes iTIND as a safe option in selected patients who wish to preserve ejaculatory function.[3]

Predictors of failure​

In the failure analysis of all 81 MT-02 patients, an obstructive median lobe was the only significant baseline predictor of iTIND failure (7 of 12 failures, 58.3%; p < 0.0001). Age, prostate volume, IPSS, Qmax, PVR and PSA did not predict failure.[7]

Comparison with other MISTs​

An author-posted preprint of the ongoing randomized MT-08 trial reports preliminary 3-month iTIND-versus-UroLift outcomes in 81 men (47 iTIND, 34 UroLift).[30] A retrospective two-center comparison of 92 iTIND and 42 UroLift patients reported similar 24-month failure rates (13.0% versus 11.9%); failure included surgical retreatment or ejaculatory dysfunction, and baseline age, gland size and median-lobe differences limit interpretation.[31] The table below compares separate studies indirectly.

ProcedureIPSS Δ (12 mo)Qmax Δ (12 mo)Volume rangeMedian lobeImplant left?
iTIND−9.3 (RCT)[1] / −12.9 (MT-02, paired n=67)[6][11]+3.5 (RCT)[1] / +7.3 (MT-02, paired n=67)[6][11]25–75 mL[9]ExcludedNone
Rezūm−11.6 (paired)[22]+5.5 (paired)[22]30–80 mL (AUA 2026 selection)[9]; FDA indication 30–150 mL[32]TreatableNone
UroLift−10.6 (paired)[23]+4.0 (paired)[23]30–80 mL (AUA 2026: no obstructing median lobe)[9]Excluded in AUA recommendationPermanent suture-tacks
Optilume BPH−12.1 (paired, n=89)[24]+10.3 (paired, n=82)[24]20–80 mLExcluded in trialsNone
Aquablation−15.1 (WATER)[25]+10.3 (WATER)[25]30–80 mL (WATER)[25]; 80–150 mL in separate WATER II cohort[26]TreatableNone
PAE−11.6 at 1 mo; −14.5 across 12–36 mo (no isolated 12-mo estimate)[28]+6.1 at 1 mo; +4.1 across 12–36 mo (no isolated 12-mo estimate)[28]Any size in cited review; multidisciplinary selection[28][17]TreatableEmbolic material
TURP−15.1 (WATER)[25]+10.6 (WATER)[25]30–80 mL (WATER)[25]TreatableNone

The Cornu 2023 network meta-analysis judged the relative efficacy of iTIND to be less clear than that of PAE, PUL and WVTT because of risk of bias in the pivotal RCT.[16] The 2021 Cochrane network meta-analysis found that TIND may give worse IPSS than TURP at short-term follow-up (MD 7.5; 95% CI −0.68 to 15.69; low-certainty evidence), with limited long-term data.[2] In the Franco 2026 pooled analysis, most MISTs, including iTIND, improved IPSS and Qmax by at least 50% at 12 months, with follow-up mostly limited to 24 months.[13]

Where iTIND fits​

Features:

  • No permanent implant, unlike UroLift's suture-tacks.
  • No tissue ablation, resection or drug delivery.
  • Short procedure time (mean 5.8 min in the first-generation study) and same-day discharge with no indwelling catheter during the in-situ period.[5][6]
  • The corrected pooled analysis recorded no postoperative anejaculation with iTIND (0%), among the lowest for MISTs (also 0% for UroLift and Optilume).[13][20]

Limitations:

  • The Qmax improvement in the pivotal RCT (+3.5 mL/s) is smaller than in the comparison table's other MISTs, whereas single-arm cohorts report much larger gains.[1][6] The difference between the RCT and single-arm results may reflect selection and the absence of a control group.
  • Exclusion of median lobes narrows the eligible population.
  • Use is limited to small and moderate prostates without a median lobe.
  • Retreatment risk is described as higher than for Rezūm or Aquablation in the Delphi consensus and device-profile review.[3][15]

Guideline status​

The AUA 2026 guideline addresses iTIND as a temporary implantable prostate device (TIPD). Clinicians may offer a TIPD to patients with LUTS/BPH and prostates of 25–75 cc without an obstructing median lobe .[9] For comparison, the same guideline states that clinicians should offer water vapor thermal therapy to patients with 30–80 cc prostates, or prostatic urethral lift to patients with 30–80 cc prostates without an obstructing median lobe .[9] EAU 2026 makes no recommendation for iTIND and lists it as under investigation.[17]

References​

1. Chughtai B, Elterman D, Shore N, et al. The iTind temporarily implanted nitinol device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a multicenter, randomized, controlled trial. Urology. 2021;153:270-276. doi:10.1016/j.urology.2020.12.022

2. Franco JV, Jung JH, Imamura M, et al. Minimally invasive treatments for lower urinary tract symptoms in men with benign prostatic hyperplasia: a network meta-analysis. Cochrane Database Syst Rev. 2021;7:CD013656. doi:10.1002/14651858.CD013656.pub2

3. Godard L, Trivedi H, Narang G, Forbes CM. Device profile of the iTind temporary implantable nitinol device for benign prostatic hyperplasia. Expert Rev Med Devices. 2025;22(8):807-815. doi:10.1080/17434440.2025.2517173

4. Nguyen AV, Verma I, Ferreira R, et al. A scoping review of office-based prostatic stents: past, present, and future of true minimally invasive treatment of benign prostatic hyperplasia. World J Urol. 2023;41(11):2925-2932. doi:10.1007/s00345-023-04508-7

5. Porpiglia F, Fiori C, Bertolo R, et al. Temporary implantable nitinol device (TIND): a novel, minimally invasive treatment for relief of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH): feasibility, safety and functional results at 1 year of follow-up. BJU Int. 2015;116(2):278-287. doi:10.1111/bju.12982

6. Porpiglia F, Fiori C, Amparore D, et al. Second-generation of temporary implantable nitinol device for the relief of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a prospective, multicentre study at 1 year of follow-up. BJU Int. 2019;123(6):1061-1069. doi:10.1111/bju.14608

7. Kadner G, Valerio M, Giannakis I, et al. Second generation of temporary implantable nitinol device (iTind) in men with LUTS: 2-year results of the MT-02 study. World J Urol. 2020;38(12):3235-3244. doi:10.1007/s00345-020-03140-z

8. De Nunzio C, Cantiello F, Fiori C, et al. Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06 study. World J Urol. 2021;39(6):2037-2042. doi:10.1007/s00345-020-03418-2

9. 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

10. Alghamlas A, Zekraoui O, Herrmann TRW, et al. The median lobe scenario. How to tackle this challenge best: systematic review and expert guidance. World J Urol. 2026;44(1):114. doi:10.1007/s00345-025-06172-5

11. Amparore D, Fiori C, Valerio M, et al. 3-year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. 2021;24(2):349-357. doi:10.1038/s41391-020-00281-5

12. Elterman D, Alshak MN, Martinez Diaz S, et al. An evaluation of sexual function in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in men treated with the temporarily implanted nitinol device. J Endourol. 2023;37(1):74-79. doi:10.1089/end.2022.0226

13. Franco A, Ditonno F, Manfredi C, et al. Systematic review and pooled analysis of functional and sexual outcomes of minimally invasive surgical treatments for benign prostatic obstruction. Eur Urol. 2026;89(4):318-331. doi:10.1016/j.eururo.2025.09.004

14. Zhang X, Liang T, Dong Y, Gao H. Minimally invasive treatments for benign prostatic hyperplasia: a narrative review. Medicine (Baltimore). 2026;105(12):e47951. doi:10.1097/MD.0000000000047951

15. 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

16. 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

17. 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.1.

18. Olympus America. "iTind System: risk information." Olympus America. iTind System IFU UI-0003 Rev 05 (2020). Manufacturer safety information.

19. Cindolo L, Olivero A, Vittori G, et al. "Functional outcomes and retreatment rates after iTIND implantation in a real-world Italian multicenter cohort: the importance of patient selection." Int Urol Nephrol. 2026. doi:10.1007/s11255-026-05335-6

20. Franco A, Ditonno F, Manfredi C, et al. "Corrigendum to Systematic review and pooled analysis of functional and sexual outcomes of minimally invasive surgical treatments for benign prostatic obstruction [Eur. Urol. 89 (2026) 318–331]." Eur Urol. 2026;90(2):185. doi:10.1016/j.eururo.2026.05.003

21. Medi-Tate Ltd. "Medi-Tate iTind System Instructions for Use." UI0003 rev.07. 9 July 2024. Manufacturer IFU.

22. Elterman D, et al. "Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes." Can J Urol. 2021;28(5):10824–10833. PMID:34657655

23. Elterman D, et al. "Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes." Can J Urol. 2021;28(5):10824–10833. PMID:34657655

24. 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

25. Gilling P, et al. "Randomized controlled trial of Aquablation versus transurethral resection of the prostate in benign prostatic hyperplasia: one-year outcomes." Urology. 2019;125:169–173. doi:10.1016/j.urology.2018.12.002

26. Bhojani N, et al. "Aquablation therapy in large prostates (80–150 mL) for lower urinary tract symptoms due to benign prostatic hyperplasia: final WATER II 5-year clinical trial results." J Urol. 2023;210(1):143–153. doi:10.1097/JU.0000000000003483

27. U.S. Food and Drug Administration. "iTind System: 510(k) K210138." 2021. FDA clearance

28. Wei JT, Dauw CA, Brodsky CN. "Lower urinary tract symptoms in men: a review." JAMA. 2025;334(9):809-821. doi:10.1001/jama.2025.7045

29. Amparore D, De Cillis S, Schulman C, Kadner G, Fiori C, Porpiglia F. "Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results." Minerva Urol Nephrol. 2023;75(6):743-751. doi:10.23736/S2724-6051.23.05322-3

30. Chughtai B, Polo J, Kella N, et al. "A randomized study comparing the iTind device versus UroLift (MT-08): interim report findings." Research Square. 2026. Preprint. doi:10.21203/rs.3.rs-9654971/v1

31. Olivero A, De Cillis S, Amparore D, et al. "Twenty-four months failure rate and functional outcomes comparison after implantable nitinol device (iTIND) and prostatic urethral lift (Urolift): real world multicenter study." Urologia. 2026;93(2):200-205. doi:10.1177/03915603251406809

32. U.S. Food and Drug Administration. "Rezūm System: 510(k) Summary K250584." 2025. FDA clearance.

33. Baboudjian M, Cornu JN, Gondran-Tellier B, et al. "Pharmacologic and Surgical Retreatment After Office-based Treatments for Benign Prostatic Hyperplasia: A Systematic Review." Eur Urol Focus. 2023;9(5):727-733. doi:10.1016/j.euf.2023.03.004