Rezum vs UroLift for Enlarged Prostate

(CLEAR Trial)

Not currently recruiting at 9 trial locations

Overseen By Cliff Kline

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: NeoTract, Inc.

Disqualifiers: Urinary infection, Catheter retention, Urethra conditions, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, UroLift and Rezūm, for men with an enlarged prostate (BPH). Researchers aim to assess how these treatments affect patients' experiences, focusing on the need for a catheter, retreatment, and medication use over a year. Men with symptoms of an enlarged prostate and a prostate size between 30 and 80 cubic centimeters qualify as candidates for this study. Participants will be randomly assigned to receive one of the two FDA-approved procedures. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for BPH.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

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?

Research has shown that both Rezum and UroLift treatments are generally safe for treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH).

Rezum uses water vapor to shrink the prostate and improve symptoms. While some individuals might experience painful or frequent urination, this is uncommon. Long-term studies suggest that Rezum remains effective and well-tolerated for at least five years.

UroLift is a simple procedure that lifts and holds the enlarged prostate tissue away from the urethra, preventing urine flow blockage. Studies involving over 300 patients demonstrated improved symptoms and lower scores on tests measuring urinary issues. Many men experienced quick recovery and symptom relief.

Both treatments have FDA approval, indicating they are safe for patients with BPH. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Rezum and UroLift as treatments for an enlarged prostate because they offer minimally invasive alternatives with unique approaches. Unlike traditional surgical options like TURP (Transurethral Resection of the Prostate), Rezum uses water vapor therapy to shrink excess prostate tissue, which might lead to fewer side effects and a quicker recovery. UroLift, on the other hand, involves placing tiny implants to lift and hold the enlarged prostate tissue out of the way, providing immediate relief without cutting or removal. These innovative techniques potentially offer faster recovery times and fewer complications compared to more invasive surgeries, making them appealing options for patients and doctors alike.

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

This trial will compare Rezūm and UroLift as treatments for an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Participants in the Rezūm arm will undergo a procedure using water vapor to shrink the prostate and ease urinary problems. Research has shown it provides long-lasting relief, with significant improvement for at least five years. Participants in the UroLift arm will undergo a procedure that lifts and holds the prostate tissue to open the urethra, improving urine flow. Studies indicate it has a low rate of requiring further treatment and maintains symptom improvement for at least 12 months, enhancing both urine flow and quality of life. Both treatments are minimally invasive and offer lasting benefits. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Men over 50 with symptoms of an enlarged prostate (30cm3 to 80cm3 in size) who haven't had previous BPH surgery, don't have a urinary infection or severe bleeding, and aren't part of another study. Those with certain urethra conditions, a penile prosthesis, or urinary sphincter implant are excluded.

Inclusion Criteria

I have been diagnosed with an enlarged prostate causing symptoms.

Willing to sign study informed consent form

I am 50 years old or older.

Exclusion Criteria

I am currently experiencing blood in my urine.

You have an implant in your urinary sphincter.

I have a condition that might prevent medical instruments from being inserted into my bladder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the UroLift or Rezūm procedure

1 day

1 visit (in-person)

Post-procedure Assessment

Participants complete voiding assessments and questionnaires at specified intervals

12 months

Visits at day 3, day 7, 2 weeks, 1 month, 3 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rezum
• UroLift

Trial Overview

The C.L.E.A.R. Study is comparing two minimally invasive procedures for enlarged prostate: UroLift and Rezūm. It focuses on patient experience after the procedure regarding the need for catheterization, retreatment rates, and use of BPH medications over a year.

How Is the Trial Designed?

Group I: UroLift Experimental Treatment 1 Intervention

Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.

Group II: Rezūm Experimental Treatment 1 Intervention

Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.

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

Approved in United States as Rezūm for:

• Benign Prostatic Hyperplasia (BPH)

Approved in European Union as Rezūm for:

• Benign Prostatic Hyperplasia (BPH)

Who Is Running the Clinical Trial?

NeoTract, Inc.

Lead Sponsor

Trials

11

Recruited

3,400+

Published Research Related to This Trial

In a study comparing Rezūm™ and Urolift™ treatments for benign prostatic hyperplasia (BPH) in 48 patients, Rezūm™ showed a trend towards greater improvement in urinary symptoms (IPSS) and quality of life after 12 months, although the difference was not statistically significant.

Both treatments had low rates of serious adverse events and did not significantly affect sexual function, but Rezūm™ had a lower retreatment rate (8.3%) compared to Urolift™ (25%), suggesting it may be a more effective long-term option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of prostatic urethral lift and water vapor thermal therapy for the treatment of symptomatic benign prostatic hyperplasia: a real-life study. Baboudjian, M., Fourmarier, M., Gondran-Tellier, B., et al.[2022]

Aquablation and TURP showed significantly better improvements in urinary outcomes for patients with benign prostatic hyperplasia (BPH) compared to the non-resective procedures, UroLift and Rezum, based on data from four randomized clinical trials.

UroLift maintained better sexual function scores compared to TURP, although Aquablation did not show this advantage, indicating a trade-off between urinary improvement and sexual function depending on the surgical method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Indirect Comparison of Newer Minimally Invasive Treatments for Benign Prostatic Hyperplasia: A Network Meta-Analysis Model. Tanneru, K., Jazayeri, SB., Alam, MU., et al.[2021]

Robot-assisted laparoscopic ureteral reimplantation (RALUR) is effective for treating primary pediatric vesicoureteral reflux (VUR) and results in shorter hospital stays compared to open ureteral reimplantation (OUR), with a mean difference of 17.80 hours.

However, RALUR requires significantly longer operation times (about 66.69 minutes more) and is associated with a higher rate of short-term postoperative complications, indicating that while it offers benefits, careful consideration of risks is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic versus open ureteral reimplantation for pediatric vesicoureteral reflux: a systematic review and meta-analysis. Deng, T., Liu, B., Luo, L., et al.[2018]

Rezūm Water Vapor Therapy is a safe and effective minimally invasive treatment for urinary retention caused by benign prostate hyperplasia (BPH), with success rates ranging from 70.3% to 100% across five studies involving catheterized patients.

No severe complications (grade ≥ III Clavien-Dindo) were reported, making it particularly suitable for frail patients with comorbidities who may not tolerate general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rezūm water vapor therapy for the treatment of patients with urinary retention and permanent catheter dependence secondary to benign prostate hyperplasia: a systematic review of the literature. Spinos, T., Katafigiotis, I., Leotsakos, I., et al.[2023]

The Rezum procedure, which involves water vapor intraprostatic injection for treating benign prostatic hyperplasia (BPH), demonstrated significant improvements in urinary and sexual function for both selected patients (Group A) and unselected patients (Group B) in a study of 426 participants.

The procedure was found to be safe and effective regardless of factors such as prostate size, comorbidities, or the use of anticoagulant medications, with low reintervention rates of 2.6% for selected patients and 3.1% for unselected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Patients Treated with Water Vapor Therapy and Meeting Randomized Clinical Trial Criteria Have Better Urinary and Sexual Outcomes Than an Unselected Cohort? Cindolo, L., Campobasso, D., Conti, E., et al.[2023]

Rezūm vapor ablation is a safe and effective minimally invasive treatment for catheter-dependent urinary retention caused by benign prostatic hyperplasia (BPH), showing significant improvements in urinary symptoms and flow rates after 6 months.

In a study of 49 patients, Rezūm led to a reduction in International Prostate Symptom Score (IPSS) from 17 to 4 and a decrease in post-void residual volume (PVR) from 900 ml to 78 ml, indicating substantial relief from urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rezūm for retention-retrospective review of water vaporization therapy in the management of urinary retention in men with benign prostatic hyperplasia. Bassily, D., Wong, V., Phillips, JL., et al.[2022]

In a study of 48 patients with upper urinary tract urothelial carcinoma, transperitoneal laparoscopic radical nephroureterectomy (TLNU) demonstrated a shorter operation time and better postoperative pain control compared to retroperitoneal laparoscopic radical nephroureterectomy (RLNU).

Both surgical techniques were found to be safe and reliable, with no significant differences in recovery times or hospital stays, indicating that TLNU may offer advantages in terms of efficiency and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy in the management of upper urinary tract urothelial carcinoma: Best practice in a single center with updated results. Ye, K., Zhong, Z., Zhu, L., et al.[2021]

In a study of 612 male patients who underwent radical cystectomy for bladder cancer, those who received orthotopic neobladder reconstruction had significantly better urethral recurrence-free survival compared to those with nonorthotopic urinary diversion, indicating that neobladder reconstruction may be a safer option.

Prostatic urethral involvement was identified as a significant risk factor for urethral recurrence, highlighting the importance of considering individual patient pathology when assessing treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of urinary diversion type on urethral recurrence following radical cystectomy for bladder cancer: Propensity score matched and weighted analyses of retrospective cohort. Yu, J., Lee, CU., Chung, JH., et al.[2023]

In a study of 11,922 patients with localized upper tract urothelial carcinoma (UTUC), those with tumors in the renal pelvis (RPUC) had better overall survival rates (71.1 months) compared to those with tumors in the ureter (UUC) (66.8 months).

Patients with UUC were less likely to receive radical nephroureterectomy surgery (56.4% vs. 84.3% for RPUC), which may contribute to their poorer survival outcomes, indicating a need for improved treatment strategies for UUC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urothelial Carcinoma of the Renal Pelvis and Ureter: Does Location Make a Difference? Lwin, AA., Hsu, CH., Chipollini, J.[2021]

The Rezūm System, a water vapor thermal therapy, significantly improved lower urinary tract symptoms (LUTS) in 179 patients over 12 months, showing consistent results with previous studies in terms of efficacy.

While the treatment had a generally acceptable safety profile, it was associated with higher rates of hematuria compared to earlier studies, indicating the need for preoperative counseling about potential adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence with The Rezūm System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes. Ines, M., Babar, M., Singh, S., et al.[2022]

In a study of 36 prostate cancer patients with bilateral ureteric obstruction, those who received upper tract decompression after androgen depletion had a mean survival of 646 days, indicating a significant benefit from this intervention.

Conversely, patients whose tumors had escaped hormonal control before obstruction had a much lower survival rate of 80 days, showing that upper tract decompression had minimal impact on their prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of bilateral ureteric obstruction and renal failure in advanced prostate cancer. Paul, AB., Love, C., Chisholm, GD.[2022]

Rezum showed greater improvement in lower urinary tract symptoms (LUTS) compared to UroLift at 24 and 36 months, with a statistically significant difference in symptom scores favoring Rezum.

UroLift was more effective in improving ejaculatory function, demonstrating significant reductions in ejaculatory dysfunction compared to Rezum, while both treatments had similar overall improvements in symptom bother over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Elterman, D., Shepherd, S., Saadat, SH., et al.[2022]

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

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