Rezum vs UroLift for Enlarged Prostate (CLEAR Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: NeoTract, Inc.
No Placebo Group
Trial Summary
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.
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.
12345What 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.
678910Is 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.
6791112Eligibility 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.
I am 50 years old or older.
My prostate size is between 30cm3 and 80cm3.
I am male.
Exclusion Criteria
I am currently experiencing blood in my urine.
I have a condition that might prevent medical instruments from being inserted into my bladder.
I currently have a urinary tract infection.
I have had surgery for an enlarged prostate.
I have urinary incontinence due to a weak bladder sphincter.
Participant Groups
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.
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
Research locations nearbySelect from list below to view details:
Urology San AntonioSan Antonio, TX
UT Southwestern Medical CenterDallas, TX
Tower UrologyLos Angeles, CA
Comprehensive UrologyRoyal Oak, MI
More Trial Locations
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Who is running the clinical trial?
NeoTract, Inc.Lead Sponsor
References
Urothelial Carcinoma of the Renal Pelvis and Ureter: Does Location Make a Difference? [2021]There is a paucity of data on outcomes of upper tract urothelial carcinoma (UTUC) arising from the renal pelvis (RPUC) versus UTUC arising from the ureter (UUC). The published literature is conflicting, and there is no consensus on patient prognosis based on disease location. The aim of this study is to compare clinical and survival outcomes based on location of primary tumor using a large national registry.
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]Radical nephroureterectomy remains the gold standard for the surgical treatment of upper urinary tract urothelial carcinoma (UTUC). Based on previous research, we prospectively compared the advantages of transperitoneal laparoscopic radical nephroureterectomy (TLNU) with a three-port technique in a single position versus retroperitoneal laparoscopic radical nephroureterectomy (RLNU).
Impact of urinary diversion type on urethral recurrence following radical cystectomy for bladder cancer: Propensity score matched and weighted analyses of retrospective cohort. [2023]The absence of randomized controlled trials and the presence of inherent selection bias in existing studies have led to ongoing uncertainty regarding the impact of urinary diversion (UD) type (orthotopic UD or non-orthotopic UD) on urethral recurrence (UR) following radical cystectomy (RC) for bladder cancer. This study aimed to assess the impact of the UD types on UR after RC and to identify predictive factors associated with UR.
Robot-assisted laparoscopic versus open ureteral reimplantation for pediatric vesicoureteral reflux: a systematic review and meta-analysis. [2018]To compare the efficacy and safety of robot-assisted laparoscopic ureteral reimplantation (RALUR) and open ureteral reimplantation (OUR) in treating primary pediatric vesicoureteral reflux (VUR) based on published literature.
The management of bilateral ureteric obstruction and renal failure in advanced prostate cancer. [2022]To investigate the effect of upper tract decompression on the prognosis of uraemia secondary to bilateral ureteric obstruction in prostate cancer, with particular reference to the hormone dependency of the tumour.
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]Half of men aged > 60 years will develop benign prostatic hyperplasia (BPH) with 40% of these men having moderate-to-severe lower urinary tract symptoms (LUTS). There is limited knowledge on a head-to-head comparison of prostatic urethral lift (UroLift) and convective water vapor ablation (Rezum) for the treatment of LUTS secondary to BPH. We sought to compare randomized controlled trials with 3-year clinical outcome data.
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]This study aimed at reporting a head-to-head comparison between water vapor thermal therapy using the Rezūm™ system and prostatic urethral lift using the Urolift™ system in men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
Do Patients Treated with Water Vapor Therapy and Meeting Randomized Clinical Trial Criteria Have Better Urinary and Sexual Outcomes Than an Unselected Cohort? [2023]Introduction: Water vapor intraprostatic injection (Rezum procedure) for benign prostatic hyperplasia (BPH) is one of the most promising minimally invasive surgical treatments. Five-year outcomes from the multicenter randomized controlled trial (RCT) demonstrated significant and durable urinary and sexual function results in selected patients. We compared the sexual and urinary outcomes of this procedure in patients satisfying inclusion criteria of the RCT with unselected patients. Materials and Methods: We prospectively followed all patients with symptomatic BPH who underwent Rezum therapy at eight institutions and analyzed the functional results. Patients were divided into two groups: patients who matched the 5-year RCT inclusion criteria (Group A) and patients who did not (Group B). The pre- and postoperative data, complications, presence of antegrade ejaculation, and urinary and sexual outcomes were periodically recorded. Results: A total of 426 patients were eligible for the study (232 in Group A and 194 in Group B). Patients in Group B had a higher American Society of Anesthesiologists score, prostate volume, and postvoid residual measurement. No difference was found in terms of preoperative International Prostate Symptom Score, International Index of Erectile Function, maximum urinary flow, and prostate-specific antigen. Longer operative time and higher number of vapor injections were required in Group B, with no differences in hospital stay, injection density, and complication rates. All the urinary and sexual outcomes improved with no differences between the two groups. The reintervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in Group B. Conclusions: In our large multicenter series, water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patients' comorbidities.
An Indirect Comparison of Newer Minimally Invasive Treatments for Benign Prostatic Hyperplasia: A Network Meta-Analysis Model. [2021]Objective: This study was designed to provide an indirect comparison of the urinary and sexual domain outcomes and complications after newer minimally invasive surgical therapy (MIST) of Aquablation, Rezum, and UroLift for benign prostatic hyperplasia (BPH) for transurethral resection of prostate (TURP). Methods: We searched Embase, Medline, and Cochrane in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, in December 2019. Only randomized clinical trials (RCTs) that reported outcomes after treatment of BPH for prostate less than 80 g with Aquablation, Rezum, or UroLift were included in the analysis. Results: A total of four RCTs reporting the outcomes after treatment with newer MIST for BPH were identified. Patients undergoing the resective procedures, that is, TURP and Aquablation, had greater improvement in urinary domain outcomes: International Prostate Symptom Score, quality of life, peak flow rate, and postvoiding residual compared to patients undergoing nonresective procedures: UroLift and Rezum. Patients in UroLift group maintained a higher sexual function domain score compared to TURP, but not Aquablation. Our multiple comparison analysis did not reveal a significant difference in urinary and sexual domain scores between patients undergoing UroLift and Rezum at 24 months of follow-up. Conclusions: Aquablation and TURP necessitate general or regional anesthesia and both produced significantly better urinary domain scores compared to Rezum and UroLift. On the other hand, UroLift demonstrated better sexual function domain scores compared to TURP, but not Aquablation. There was no significant difference in urinary domain scores between UroLift and Rezum at 24 months of follow-up.
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]To provide 12-month unbiased outcomes with The Rezūm System (Rezūm), a convective water vapor thermal therapy for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Results from this retrospective, real-world evidence (RWE) study were compared to those of previous studies with the aim to evaluate the device's safety and efficacy in a real-world patient population.
Rezūm for retention-retrospective review of water vaporization therapy in the management of urinary retention in men with benign prostatic hyperplasia. [2022]Rezūm vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezūm is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, it is unclear how effective Rezūm is for men in urinary retention. We sought to determine whether Rezūm is effective in the treatment of catheter-dependent urinary retention secondary to BPH.
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]Recurrent urinary retention due to benign prostate hyperplasia (BPH), requiring permanent catheterization, represents one of the most challenging issues geriatric patients can face. Rezūm, as a minimal invasive treatment for BPH, takes the advantage of sterile water vapor injections directly into the prostate. The purpose of this Systematic Review is to report the safety and the efficacy of Rezūm regarding urinary retention relief and permanent catheter withdrawal.