A randomized study comparing the iTind™ device versus UroLift™ (MT-08) - Interim report findings

Technical Summary: Interim Report of the MT-08 Randomized Study Comparing iTind™ and UroLift™

Problem Statement
Benign prostatic hyperplasia (BPH) is a leading cause of lower urinary tract symptoms (LUTS) in aging men. While surgical interventions like transurethral resection of the prostate (TURP) offer durable relief, they carry risks of bleeding, incontinence, and sexual dysfunction. Minimally invasive surgical therapies (MISTs) have emerged as alternatives to preserve sexual function and reduce morbidity. Two distinct mechanical MISTs are the prostatic urethral lift (PUL; UroLift™), which uses permanent implants to compress prostatic lobes, and the Temporarily Implanted Nitinol Device (iTind™), which utilizes temporary radial expansion to reshape the bladder neck and prostatic urethra before removal. Despite prior prospective studies validating each technique independently, head-to-head comparative data in a controlled setting has been limited. The MT-08 study addresses this gap by directly comparing the safety and efficacy of these two devices.

Methodology
The MT-08 study is a prospective, randomized, global multicenter trial comparing the iTind™ device against UroLift™.

• Study Design: Participants were randomized 1:1 to receive either the iTind™ device or UroLift™.
• Population: The interim analysis included the first 81 men enrolled across 15 sites in the US and UK. Eligible criteria included age ≥50, prostate volume ≤75 mL, and baseline International Prostate Symptom Score (IPSS) ≥13. Exclusions included median lobe enlargement, prior prostate surgery, or confounding urologic conditions. Patients on alpha-blockers underwent a 2-week washout period.
• Analysis Population: The interim data cut occurred after the first 81 participants reached 3 months post-implantation. One patient in the iTind™ arm withdrew after 1 month, resulting in an analysis set of 80 participants (46 iTind™, 34 UroLift™).
• Endpoints: The study evaluated procedure- and device-related adverse events (AEs) graded by the Clavien-Dindo classification, changes in IPSS (testing for non-inferiority with a 4-point margin), maximum urinary flow rate (Qmax), post-void residual (PVR), and quality-of-life metrics (SHIM, MSHQ-EjD, SF-6D v2). Statistical analyses utilized t-tests for continuous variables and chi-square or Fisher's exact tests for categorical data.

Key Contributions
This paper provides the first prospective, randomized, head-to-head comparison of two mechanical MISTs for BPH. It offers early data on:

1. Comparative Safety: A detailed temporal analysis of adverse events, specifically distinguishing between events occurring during implantation, within the first month, and between months 1–3.
2. Efficacy Metrics: Direct comparison of symptom relief (IPSS), flow rate improvements (Qmax), and preservation of sexual function.
3. Procedural Efficiency: Assessment of procedure duration, anesthesia requirements, and post-procedure catheterization rates.
4. Device Characteristics: Evaluation of the clinical implications of a temporary implant (iTind™) versus a permanent implant (UroLift™) in terms of recovery and tissue reaction.

Results

• Demographics: The mean age was 64 years in both groups. The iTind™ arm had a significantly smaller baseline prostate volume (38 mL vs. 48 mL; P=0.0043) and a slightly higher incidence of comorbidities such as hypertension and heart disease.
• Efficacy (3-Month Follow-up):
  • Symptom Relief: Both devices demonstrated significant improvement in IPSS. The mean improvement was −10.0 ± 7.6 for iTind™ and −11.6 ± 7.7 for UroLift™. The between-group difference in mean improvement was −1.6 points, which did not exceed the minimal clinically important difference (MCID) of 3 points, indicating comparable efficacy. Both groups showed comparable improvements in storage and voiding subdomains.
  • Flow Rate: Qmax increased by +3.7 mL/s in the iTind™ arm and +4.3 mL/s in the UroLift™ arm.
  • Sexual Function: Both treatments preserved erectile and ejaculatory function, with no significant changes in SHIM or MSHQ-EjD scores.
  • Quality of Life: SF-6D v2 improved in both groups, with no significant between-group difference.
• Safety:
  • Adverse Events: The overall AE incidence at 3 months was 32.6% for iTind™ and 47.1% for UroLift™ (difference −14.5%; P=0.1897).
  • Temporal Distribution: No AEs occurred after 1 month in the iTind™ arm, whereas the UroLift™ arm recorded one case of urinary urgency between months 1 and 3. The iTind™ arm showed lower AE rates on the day of implantation (6.4% vs. 20.6%) and from 1 week to 1 month post-implantation.
  • Severity: The majority of complications were Grade I (Clavien-Dindo). No device malfunctions, migrations, or cases of de novo erectile dysfunction, incontinence, or persistent pain were reported in either arm.
• Procedural Metrics: The mean procedure time was shorter for iTind™ (6.4 ± 3.7 min) compared to UroLift™ (9.8 ± 5.2 min). Post-implantation catheterization was required in 4.3% of iTind™ patients versus 21% of UroLift™ patients.

Significance and Claims
The authors conclude that at 3 months, the iTind™ device demonstrates a favorable safety profile with no mid-term adverse events reported, offering symptomatic improvement comparable to UroLift™. The study highlights that both therapies achieve rapid recovery and preservation of sexual function.

The paper claims that the iTind™ device's temporary nature (removed after 5–7 days) may appeal to patients seeking a solution without permanent implants. The shorter procedure time and reduced need for catheterization and general anesthesia suggest the iTind™ device offers improved workflow efficiency, particularly in outpatient or office settings with limited anesthesia resources. The authors emphasize that these interim findings support the continued investigation of the iTind™ device as a safe, effective, and low-resource-intensity therapy within the BPH treatment continuum. However, the authors explicitly state that the study is not powered for formal superiority testing and that final data including all planned patients are required to validate these interim findings and assess long-term durability.