An interventional study of iTind and UroLift in Benign Prostatic Hyperplasia (BPH), sponsored by Olympus Corporation of the Americas. Recruiting at 19 sites in 2 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Olympus Corporation of the Americas (part of Olympus Corporation) · Not applicable, Interventional, and Treatment
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 256 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The iTind is a minimally invasive temporary implant
Device: iTind
The UroLift is a minimally invasive permanent implant
Procedure: UroLift
The iTind is implemented for 5-7 days
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Time frame: 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
Time frame: 12 month
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
Time frame: 3 month
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
Time frame: 1, 6, 24, and 36 months
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
Time frame: 1, 3, 6, 12, 24, and 36 months
Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months
Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months
Time frame: 1, 3, 6, 12, 18, 24, and 36 months
Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events
Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events
Time frame: 1, 6, 12, 18, 24, and 36, months
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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