Rezum vs UroLift for Enlarged Prostate

(CLEAR Trial)

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

120 Participants Needed

Trial Summary

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.

What data supports the idea that Rezum vs UroLift for Enlarged Prostate is an effective treatment?

The available research does not provide any data on Rezum or UroLift for treating an enlarged prostate. The studies listed focus on other conditions and treatments, such as pediatric vesicoureteral reflux, upper tract urothelial carcinoma, and prostate cancer-related issues. Therefore, no specific data from these studies can be used to support the effectiveness of Rezum or UroLift for an enlarged prostate. ^{1 2 3 4 5}

What safety data exists for Rezum and UroLift treatments for enlarged prostate?

The safety data for Rezum and UroLift treatments for benign prostatic hyperplasia (BPH) indicate that both procedures are minimally invasive and have been evaluated in various studies. Rezum, a water vapor therapy, has shown significant and durable improvements in urinary and sexual function over five years, with low reintervention rates and a safe profile across different patient groups. UroLift, a prostatic urethral lift, maintains higher sexual function scores compared to some other treatments. Both treatments have similar urinary and sexual outcomes at 24 months, with no significant differences in complication rates. Real-world evidence supports the safety and efficacy of Rezum across a broad range of prostate volumes. ^{6 7 8 9 10}

Is Rezum or UroLift safe for treating an enlarged prostate?

Both Rezum and UroLift are considered safe for treating an enlarged prostate, with studies showing improvements in urinary and sexual outcomes. Complication rates are low, and both treatments have been shown to be effective across different patient groups. ^{6 7 8 9 10}

Is the treatment Rezum or UroLift a promising treatment for an enlarged prostate?

Yes, both Rezum and UroLift are promising treatments for an enlarged prostate. They are minimally invasive and help improve urinary symptoms. Rezum uses water vapor to treat the prostate, while UroLift lifts and holds the prostate tissue. Both treatments have shown similar improvements in urinary symptoms over time. ^{6 7 9 11 12}

How do Rezum and UroLift treatments for enlarged prostate differ from other treatments?

Rezum and UroLift are minimally invasive treatments for enlarged prostate (BPH) that do not require general anesthesia, unlike more invasive surgeries like TURP. Rezum uses water vapor to ablate prostate tissue, while UroLift involves lifting and holding the enlarged prostate tissue away from the urethra to improve urine flow. Both treatments aim to reduce urinary symptoms with less impact on sexual function compared to traditional surgeries. ^{6 7 9 11 12}

What is the purpose of this trial?

C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Urothelial Carcinoma of the Renal Pelvis and Ureter: Does Location Make a Difference? [2021]

2. England 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. [2021]

3. United States 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic versus open ureteral reimplantation for pediatric vesicoureteral reflux: a systematic review and meta-analysis. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The management of bilateral ureteric obstruction and renal failure in advanced prostate cancer. [2022]

6. Canada 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. [2022]

7. Netherlands 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. [2022]

8. United States 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? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

An Indirect Comparison of Newer Minimally Invasive Treatments for Benign Prostatic Hyperplasia: A Network Meta-Analysis Model. [2021]

10. United States 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. [2022]

11. United States 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. [2022]

12. Germany 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. [2023]