iTind vs UroLift for Enlarged Prostate

(MT-08 Trial)

Recruiting at 28 trial locations

Overseen By Lina Ginnetti, MA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Medi-Tate Ltd.

Must not be taking: Alpha blockers, Anticoagulants

Disqualifiers: Prostate cancer, Bladder cancer, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

206 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for men with an enlarged prostate that causes urinary problems. It compares the safety of iTind, a temporary implant, with UroLift, a permanent implant. Men experiencing urinary issues due to a non-cancerous enlarged prostate and who have been recommended for treatment may be suitable candidates. The trial seeks to determine which treatment is safer for managing these symptoms. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for alpha blockers. Also, you cannot take anti-platelet or anticoagulants (blood thinners) except for low dose aspirin within 7 days before joining the trial.

What prior data suggests that the iTind and UroLift devices are safe for treating an enlarged prostate?

Research shows that the iTind device is generally well-tolerated for treating an enlarged prostate. Studies indicate it is a safe choice for those who want to maintain their ability to ejaculate. Additionally, long-term data suggests that the iTind procedure provides lasting relief from urinary problems.

Similarly, UroLift has proven to be safe and effective. Results from over 145 studies demonstrate that it offers long-term improvement in symptoms. Patients report better sexual function and shorter catheterization times after the procedure.

Both iTind and UroLift are minimally invasive treatments, meaning they carry less risk than traditional surgery. While both treatments have strong safety records, potential trial participants should talk with their healthcare providers to understand any possible risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the iTind and UroLift treatments for enlarged prostate because they offer minimally invasive solutions with unique features. The iTind device is a temporary implant designed to reshape prostate tissue and improve urinary flow, providing relief without the need for permanent changes or incisions. On the other hand, UroLift is a permanent implant that lifts and holds the prostate tissue out of the way, opening the urethra directly. Unlike traditional surgical options that often involve cutting or removing tissue, both iTind and UroLift aim to improve symptoms with less recovery time and fewer risks, making them attractive alternatives to more invasive procedures.

What evidence suggests that this trial's treatments could be effective for an enlarged prostate?

This trial will compare the iTind device with the UroLift system for treating an enlarged prostate. Studies have shown that the iTind device, which participants in one arm of this trial may receive, can significantly reduce symptoms of an enlarged prostate, with improvements lasting over four years for many patients. However, some people might need additional treatment later on. The UroLift system, which participants in another arm of this trial may receive, has also proven effective in studies involving over 300 men, showing a decrease in prostate symptoms and a low rate of needing further treatment—about 13.6% over five years. Both treatments are minimally invasive, aiming to relieve symptoms without major surgery. While both have been successful, the UroLift system's long-term results suggest more consistent outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Neil Barber, MD

Principal Investigator

Frimley Park Hospital

Bilal Chughtai, MD

Principal Investigator

Plainview Hospital

Are You a Good Fit for This Trial?

Men aged 50 or older with an enlarged prostate (up to 75 cc in size) and symptoms of bladder outlet obstruction can join this trial. They must have a PSA level below 4 mg/dl, or if between 4-10 mg/dl, a negative biopsy within the last six months. Participants need to be able to complete study visits and questionnaires.

Inclusion Criteria

I am a man aged 50 or older.

I am willing and able to attend all study visits and complete questionnaires.

Willing and able to provide informed consent

Exclusion Criteria

I cannot stop taking my alpha blockers or 5ARIs for the required time.

My prostate's median lobe is enlarged, confirmed by imaging.

I have not had blood in my urine or bladder stones in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the iTind or UroLift procedure to relieve lower urinary tract symptoms

Intraoperative

1 visit (in-person)

Post-procedure

Participants are monitored for post-operative complications and recovery

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

What Are the Treatments Tested in This Trial?

Interventions

• iTind
• UroLift

Trial Overview

This study is comparing the safety of two minimally invasive procedures for treating benign prostatic hyperplasia: iTind versus UroLift. Men participating will undergo one of these treatments randomly to see which has fewer complications.

How Is the Trial Designed?

Group I: iTind arm Experimental Treatment 1 Intervention

The iTind is a minimally invasive temporary implant

Group II: UroLift Active Control 1 Intervention

The UroLift is a minimally invasive permanent implant

iTind is already approved in European Union, United States, Brazil for the following indications:

Approved in European Union as iTind for:

• Benign Prostatic Hyperplasia (BPH)

Approved in United States as iTind for:

• Symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and older

Approved in Brazil as iTind for:

• Benign Prostatic Hyperplasia (BPH)

Who Is Running the Clinical Trial?

Medi-Tate Ltd.

Lead Sponsor

Trials

8

Recruited

680+

Olympus Corporation of the Americas

Lead Sponsor

Trials

22

Recruited

2,500+

Olympus Europe SE & Co. KG

Industry Sponsor

Trials

4

Recruited

1,800+

Published Research Related to This Trial

In a 3-year study involving 81 men with benign prostatic obstruction, the iTIND device showed significant and lasting improvements in lower urinary tract symptoms, with reductions in symptom scores and enhancements in urinary flow and quality of life.

The treatment was safe, with no late postoperative complications or sexual dysfunction reported, indicating that iTIND is a reliable option for managing BPO-related LUTS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Amparore, D., Fiori, C., Valerio, M., et al.[2022]

The iTIND device is a safe and effective treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), showing significant improvements in urinary flow rates and symptom scores over a 12-month follow-up with no serious complications reported.

All patients maintained their sexual and ejaculatory functions after the procedure, indicating that iTIND implantation does not negatively impact these aspects of quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Porpiglia, F., Fiori, C., Amparore, D., et al.[2020]

The iTind device demonstrated significantly better safety compared to the prostatic urethral lift (PUL), with only 25% of iTind patients experiencing treatment-related adverse events within 3 months, compared to 79.8% for PUL patients.

Both iTind and PUL showed equivalent efficacy in improving urinary and sexual health metrics after 12 months, indicating that while iTind is safer, it is just as effective as PUL for treating lower urinary tract symptoms due to benign prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporarily implanted nitinol device versus prostatic urethral lift for minimally invasive surgical treatment of benign prostatic hyperplasia with lower urinary tract symptoms: a matching-adjusted indirect comparison. Kernen, KM., Omar, S., Goodnight, B., et al.[2023]

The iTind device is a minimally invasive treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) that effectively preserves sexual function and urinary continence in all 70 patients studied over a 6-month period.

Patients experienced significant improvements in their urinary symptoms and flow rates, with a quick recovery time, averaging just 4.3 days to return to daily activities after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. De Nunzio, C., Cantiello, F., Fiori, C., et al.[2021]

The iTind device is a temporary prostatic urethral device approved by the FDA that can be implanted without sedation or general anesthesia, making it a less invasive option for treating benign prostatic hyperplasia in aging men.

Clinical studies show that iTind leads to favorable functional and sexual outcomes for patients, highlighting its efficacy in improving quality of life for those affected by this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I Do It: Temporarily Implanted Nitinol Device (iTind). Elterman, D., Gao, B., Zorn, KC., et al.[2021]

The iTIND device is a minimally invasive treatment for lower urinary tract symptoms (LUTS) due to benign prostate enlargement, showing improved efficacy and safety compared to its predecessor.

12-month follow-up data indicates that iTIND significantly enhances both objective and subjective measures of symptom relief, and it can be implanted under local anesthesia in an office setting, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iTIND: the second-generation temporary implantable nitinol device for minimally invasive treatment of benign prostatic hyperplasia. Balakrishnan, D., Jones, P., Somani, BK.[2020]

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