What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate include medications like alpha-blockers (e.g., tamsulosin, alfuzosin) and 5-alpha-reductase inhibitors (e.g., finasteride), minimally invasive procedures like UroLift, and surgical options. Alpha-blockers can cause dizziness, fatigue, and orthostatic hypotension. 5-alpha-reductase inhibitors may lead to sexual dysfunction, including decreased libido and erectile dysfunction. The UroLift system, which is similar to iTind, can cause temporary side effects such as pain or discomfort during urination, blood in the urine, and pelvic pain. Serious complications are rare but can include infection and urinary retention.

What prior FDA approvals exist?

The FDA has approved several treatments for benign prostatic hyperplasia (BPH) that aim to relieve lower urinary tract symptoms (LUTS). One notable device is the UroLift System, which involves the placement of small implants to lift and hold the enlarged prostate tissue out of the way, thus opening the urethra. Medications such as alpha-adrenergic blockers (e.g., tamsulosin, alfuzosin) and 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) are also commonly used to manage BPH symptoms. These treatments aim to improve urine flow and reduce BPH symptoms, similar to the objectives of the iTind device.

What other types of research exist?

Promising novel alternatives to iTind for treating an enlarged prostate (BPH) include: 1) UroLift System, which uses small implants to lift and hold the enlarged prostate tissue out of the way, 2) Aquablation, a waterjet ablation therapy that removes prostate tissue using a high-velocity waterjet, and 3) Holmium Laser Enucleation of the Prostate (HoLEP), which uses a laser to remove obstructive prostate tissue. These treatments have shown efficacy and safety in clinical trials and are minimally invasive options for patients.

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Device

iTind vs UroLift for Enlarged Prostate (MT-08 Trial)

N/A

Recruiting

Led By Bilal Chughtai, MD

Research Sponsored by Medi-Tate Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males ≥ 50 years of age or older

Maximum urinary flow rate (Qmax) of ≤ 12 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)

Must not have

Prostate volume > 75 cc

Median lobe obstruction of the prostate as confirmed by TRUS or MRI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 12, 18, 24, 36, 48, and 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the safety of the iTind device with UroLift for men who have urinary problems because of an enlarged prostate. The iTind device temporarily reshapes the prostate tissue to help improve urine flow. iTIND is the second-generation version of a temporary implantable device, which is one of the latest minimally invasive surgeries available to treat bothersome lower urinary tract symptoms caused by benign prostate enlargement.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from iTind and UroLift may include discomfort during urination, blood in urine, urinary tract infection, temporary difficulty with urination, or pelvic pain. Allergic reactions could occur in those sensitive to materials like nickel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 50 or older.

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My urine flow rate is between 5 and 12 mL/sec.

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I have symptoms from an enlarged prostate that needs treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate is larger than 75 cc.

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

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I have been diagnosed with a condition affecting my bladder or urethra.

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I have bladder control issues due to a neurological condition like Parkinson's or diabetes.

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I use a catheter or cannot urinate on my own.

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I have a significant pouch in my bladder.

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I currently have a urinary tract infection.

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I was diagnosed with bladder cancer in the last 2 years.

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I have had surgeries or treatments in my pelvic area that might interfere with certain prostate or urinary treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, 12, 18, 24, 36, 48, and 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, 12, 18, 24, 36, 48, and 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 12, 18, 24, 36, 48, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of all intraoperative and post-operative complications

Secondary study objectives

Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS)

Difference in change from baseline between iTind and UroLift groups in Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD)

Difference in change from baseline between iTind and UroLift groups in Sexual Health Inventory for Men (SHIM)

+3 more

Other study objectives

Difference between iTind and UroLift groups for Anesthesia type

Difference between iTind and UroLift groups for Hospital length of stay

Difference between iTind and UroLift groups for Number of UroLift impants (UroLift arm only)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: iTind armExperimental Treatment1 Intervention

The iTind is a minimally invasive temporary implant

Group II: UroLiftExperimental Treatment1 Intervention

The UroLift is a minimally invasive permanent implant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

UroLift

2018

N/A

~20

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for an enlarged prostate, such as the iTind device, UroLift, alpha-blockers, and 5-alpha-reductase inhibitors, work through different mechanisms to relieve lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The iTind device temporarily reshapes the prostatic urethra to improve urine flow. UroLift involves the placement of implants that hold the enlarged prostate tissue away from the urethra, reducing obstruction. Alpha-blockers relax the smooth muscles in the prostate and bladder neck, easing urine flow. 5-alpha-reductase inhibitors shrink the prostate by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate growth. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the severity of symptoms and individual patient needs.