MIST Therapies for Enlarged Prostate

Overseen By Premal Patel, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Manitoba

Disqualifiers: ASA 3, Active UTI, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Rezum (a water vapor therapy) and iTind (a temporarily implanted nitinol device), to evaluate their effectiveness for men with an enlarged prostate. Researchers aim to compare these treatments to determine which one better improves symptoms and urine flow, and which has fewer side effects. The trial suits men experiencing bothersome prostate symptoms who are considering Rezum or iTind procedures. Participants will assist doctors in determining which treatment more effectively eases symptoms and enhances quality of life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that the iTind device led to mostly minor complications, which resolved on their own within a week. Only one significant issue occurred, and overall, the device is considered safe for treating an enlarged prostate. It is particularly popular among those who wish to maintain normal ejaculation.

Research indicates that Rezum therapy is a safe and effective option for treating urinary problems related to an enlarged prostate. Some individuals might experience painful or frequent urination, but these side effects are usually manageable. Both iTind and Rezum therapies have proven to be well-tolerated by patients, offering safe options for managing prostate issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for an enlarged prostate because they offer minimally invasive options with potentially fewer side effects compared to traditional methods like surgery or medication. The Rezum procedure uses water vapor therapy to reduce prostate size, which may lead to quicker recovery times and less discomfort. The iTind procedure involves temporarily placing a device in the prostate to reshape the tissue, which can improve urinary symptoms without the need for permanent implants. Both treatments aim to provide effective relief with less downtime and risk than conventional approaches.

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

In this trial, participants will join one of two treatment arms. Studies have shown that Rezum water vapor therapy, which participants in one arm may receive, can significantly improve symptoms in men with an enlarged prostate. Research indicates that within 12 months, patients experienced fewer symptoms and better urine flow, with these improvements lasting up to five years. Similarly, the iTind device, which participants in the other arm may receive, has effectively reduced symptoms related to an enlarged prostate. Long-term studies show that iTind provides lasting relief, though there might be a slightly higher chance of needing a repeat treatment compared to other methods. Both treatments are minimally invasive options for managing prostate enlargement, making them appealing choices for potential trial participants. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men over 18 with benign prostatic hyperplasia (BPH), also known as an enlarged prostate, who are undergoing Rezum or iTind treatments. It's not suitable for those with a high surgical risk (ASA 3+), recent urinary tract infections, minors, or anyone unable to consent.

Exclusion Criteria

Lack of informed consent

I am under 18 years old.

My health is severely impacted by my disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Rezum or iTind procedure for BPH/LUTS

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Visits at 1 week, 6 weeks, and 3 months post-procedure

Long-term Follow-up

Continued monitoring of symptom scores and uroflow parameters

6 months

What Are the Treatments Tested in This Trial?

Interventions

• iTind
• Rezum

Trial Overview The study compares two minimally invasive treatments for BPH at the Men's Health Clinic in Winnipeg: Rezum water vapor therapy and the iTind device. It aims to evaluate improvements in symptoms and urine flow while assessing side effects over one year.

How Is the Trial Designed?

Group I: iTind Experimental Treatment 1 Intervention

This arm will receive the iTind Procedure

Group II: Rezum Experimental Treatment 1 Intervention

This arm will receive the Rezum procedure.

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?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/products/rezum/rezum-5-year-data.html

Rezūm 5-Year Clinical Data | Proven Five Year Durability Rezūm™ Water Vapor Therapy is now the only in‐office BPH therapy with proven prostate volume reduction and long-term durability out to 5 years while ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6180381/

Rezum: a new transurethral water vapour therapy for ... The crossover trial has demonstrated a mean improvement of IPSS at 12 months from 19.4 to mean 8.6, a mean Qmax improvement from 10.3 ml/s to 16.2 ml/s and a ...

3. nature.com nature.com/articles/s41391-024-00836-w

Real-world experience of water vapour therapy (Rezum) in ... Rezum is effective and can improve urinary symptoms. In appropriate patients, Rezum can significantly reduce the bladder outlet obstruction (BOO).

4. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/procedures-and-treatments/benign-prostatic-hyperplasia/physicians-perspectives/rezum-therapy-five-year-clinical-data-outcomes.html

Rezūm Therapy five-year clinical data outcomes This latest data publication confirms Rezūm Therapy safely and effectively reduces benign prostatic hyperplasia (BPH) symptoms while preserving sexual function ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379829/

Outcomes of Rezum water vapor therapy for benign prostate ... Rezum therapy is regarded as a safe, effective, and minimally invasive option for treating lower urinary tract symptoms in men with benign prostatic hyperplasia ...

6. rezum.com rezum.com/what-is-rezum/risks.html

Rezūm Procedure Risks | Rezūm Safety Information Potential risks associated with Rezūm Water Vapor Therapy include, but are not limited to: painful or frequent urination.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666168323018086

Benign Prostatic Hyperplasia Prospective Trial of Water ... Our prospective study corroborates previous findings indicating that Rezūm water vapor therapy is a safe and effective option for men with a larger prostate who ...