Benign Prostatic Hyperplasia (BPH)MT-08NCT04757116
Post-Market Study to Assess iTind Safety in Comparison to UroLift
A study testing iTind and UroLift in people with Benign Prostatic Hyperplasia (BPH), run by Olympus Corporation of the Americas at 19 sites in 2 countries.
Trial summary
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- iTind and UroLift
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 26 Sep 2022to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
- Willing and able to provide informed consent
- Males ≥ 50 years of age or older
- PSA < 4 ng/ml or if the PSA is 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months
- Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening
- International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13
- Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
- Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits
Who cannot join
- History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months
- Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer
- History of acute bacterial prostatitis within the last 2 years
- Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
- PSA value > 10 ng/ml
- Contraindicated for iTind or UroLift as determined by the PI
Show all 18Show fewer
- Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function
- Clinically significant bladder diverticulum
- Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
- Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease treatment if the therapy may potentially cause injury to site (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis if it may prevent insertion of the iTind or UroLift device
- An active urinary tract infection during randomization
- Clinically significant hematuria within the last 3 months or ongoing cystolithiasis
- Prostate volume > 75 cc
- Post-void residual volume (PVR) > 250 mL
- Actively using catheterization or unable to void naturally
- Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure
- Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure
- Known or suspected allergy to nickel, titanium or polyester/polypropylene
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
United States15 sites, 11 recruiting
- Recruiting
Potomac Urology Center
Alexandria, Virginia, 22311
Chamin Lim, 703-680-2111 ext. 423, clim@potomacurology.com
Nilay Gandhi, MD
- Recruiting
Midtown Urology Associates
Austin, Texas, 78705
Andrew Barger, 512-451-7935, APBarger@cimplify.net
Tyler McClintock, MD
- Terminated
NorthShore University Health System Research Institute
Evanston, Illinois, 60201
- Recruiting
Urology Associates of Central California
Fresno, California, 93720
Joe Vidal, 559-720-3646 ext. 559-321-2919, jvidal@urologyassociates.net
William Schiff, MD
- Recruiting
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
Jessica Parks, 901-464-2711, jessica.parks@conradpearson.com
Adam Stewart, MD
- Recruiting
Houston Metro Urology
Houston, Texas, 77027
Lena Ellis, 713-634-4405, lena.ellis@hmutx.com
Mark Sutton, MD
- Recruiting
Pacific West Urology
Las Vegas, Nevada, 89121
John Dull, 702-321-8045, john.dull@pacificwesturology.com
Joel Abbott, MD
- Active, not recruiting
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119
- Recruiting
The Urology Center
Omaha, Nebraska, 68124
Amy Nelson, 402-397-7989, anelson@adultpediatricuro.com
Sida Niu, MD
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Rev Vilasan Shylaja, 480-574-1466, VilasanShylaja.Revathy@mayo.edu
Mitchell Humphreys, MD
- Recruiting
Golden State Urology
Sacramento, California, 95823
Sehaj Sethi, 916-245-8888 ext. 308, ssethi@goldenstateurology.com
Prithipal Sethi, MD
- Recruiting
The Urology Place
San Antonio, Texas, 78240
Raji Thiruppathiraj, 210-617-3670, raji@theupi.com
Naveen Kella, MD
- Recruiting
Feinstein Institutes for Medical Research / Northwell Health
Syosset, New York, 11791
Jennifer Polo, 516-628-5926, jpolo1@northwell.edu
Bilal Chughtai, MD
- Terminated
Arizona Urology Specialists
Tucson, Arizona, 85704
- Withdrawn
Minnesota Urology
Woodbury, Minnesota, 55125
United Kingdom4 sites, 4 recruiting
- Recruiting
Queen Margaret Hospital
Dunfermline, KY12 0SU
Keith Boath, +44-1383-623623 ext. 20951, Keith.boath@nhs.scot
Feras Al Jaafari, MD
- Recruiting
Chelsea and Westminster Hospital
Isleworth, Middlesex, TW7 6AF
Farrah Akkouch, +44 (0)20 321 5181, chelwest.wmh.olympus@nhs.net
Samuel Bishara, MD
- Recruiting
Frimley Park Hospital
London, GU16 7UJ
Reynette Baroman, r.baroman@nhs.net
Neil Barber, MD
- Recruiting
Norfolk & Norwich University Hospital
Norwich, NR4 7UY
Catherine Rennie, +44-1603 646105, catherine.rennie@nnuh.nhs.uk
Mark Rochester, MD
About this study
Official title: 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)
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
Read the 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)
- Being tested
- iTind, UroLift
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTindDevice
The iTind is implemented for 5-7 days
UroLiftProcedure or surgery
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
| Study group | Role | What they receive |
|---|---|---|
| iTind arm | Experimental | The iTind is a minimally invasive temporary implant Receives: Device: iTind |
| UroLift | Active comparator | The UroLift is a minimally invasive permanent implant Receives: Procedure: UroLift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1, 6, 12, 18, 24, and 36, months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start26 Sep 2022
- Primary completion15 Jul 2027 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Olympus Europe SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Bilal Chughtai, MD, Principal investigator, Northwell HealthNeil Barber, MD, Principal investigator, Frimley Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757116
- Sponsor's protocol ID
- MT-08
- Acronym
- MT-08
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04757116
- Acronym / sponsor ID
- MT-08 / MT-08
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Collaborators
- Olympus Europe SE & Co. KG
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to evaluate the efficacy and safety of the iTind device compared 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTind arm | Experimental | Device: iTindThe iTind is a minimally invasive temporary implant |
| UroLift | Active comparator | Procedure: UroLiftThe UroLift is a minimally invasive permanent implant |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
- Willing and able to provide informed consent
- Males ≥ 50 years of age or older
- PSA < 4 ng/ml or if the PSA is 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months
- Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening
Key exclusion criteria (18 listed)
- History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months
- Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer
- History of acute bacterial prostatitis within the last 2 years
- Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
- PSA value > 10 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTindThe iTind is implemented for 5-7 days | Device | iTind arm |
| UroLiftUroLift is a minimally invasive procedure where permanent implants are placed in the prostate. | Procedure or surgery | UroLift |
Primary outcome
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 3 months
6 secondary outcomes
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.
Time frame: 3 month
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
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
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
Time frame: 1, 6, 12, 18, 24, and 36, months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bilal Chughtai, MD principal investigator
Northwell Health
Neil Barber, MD principal investigator
Frimley Park Hospital
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTind and UroLift in people with Benign Prostatic Hyperplasia (BPH), run by Olympus Corporation of the Americas at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Bonds, MS (+1-703-851-4615, Melanie.Bonds@olympus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.