NCT04757116

Post-Market Study to Assess iTind Safety in Comparison to UroLift

A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to evaluate the safety of the iTind device comparied to UroLift.

Detailed description

Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen. This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DEVICE	iTind	The iTind is implemented for 5-7 days
PROCEDURE	UroLift	UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

Timeline

• Start date: 2022-09-26
• Primary completion: 2026-06-30
• Completion: 2031-12-31
• First posted: 2021-02-17
• Last updated: 2025-10-31

Locations

18 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study