120 Participants Needed

Rezum vs UroLift for Enlarged Prostate

(CLEAR Trial)

Recruiting at 9 trial locations
EF
AT
AT
CK
Overseen ByCliff Kline
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: NeoTract, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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 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.12345

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.12345

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.12467

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.12467

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.89101112

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.
See 2 more

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.
See 6 more

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?
2Treatment groups
Experimental Treatment
Group I: UroLiftExperimental Treatment1 Intervention
Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.
Group II: RezūmExperimental Treatment1 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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

NeoTract, Inc.

Lead Sponsor

Trials
11
Recruited
3,400+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Urothelial Carcinoma of the Renal Pelvis and Ureter: Does Location Make a Difference? [2021]
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]
Impact of urinary diversion type on urethral recurrence following radical cystectomy for bladder cancer: Propensity score matched and weighted analyses of retrospective cohort. [2023]
Robot-assisted laparoscopic versus open ureteral reimplantation for pediatric vesicoureteral reflux: a systematic review and meta-analysis. [2018]
The management of bilateral ureteric obstruction and renal failure in advanced prostate cancer. [2022]
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]
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]
Do Patients Treated with Water Vapor Therapy and Meeting Randomized Clinical Trial Criteria Have Better Urinary and Sexual Outcomes Than an Unselected Cohort? [2023]
An Indirect Comparison of Newer Minimally Invasive Treatments for Benign Prostatic Hyperplasia: A Network Meta-Analysis Model. [2021]
10.United Statespubmed.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 Statespubmed.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]
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]
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