Robotic vs Laser Surgery for Enlarged Prostate
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: Cognitive impairment, Coagulopathy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Surgical treatments for benign prostatic hyperplasia (BPH) are necessary when non-procedural approaches fail to alleviate lower urinary tract symptoms (LUTS) or bladder outlet obstruction (BOO). Open simple prostatectomy and laser enucleation are recommended for prostatic adenoma size greater than 80 ml. Minimally invasive approaches, such as robotic-assisted simple prostatectomy, have gained popularity due to their comparable outcomes with lower morbidity. The introduction of the da Vinci single-port (SP) robotic platform offers potential advantages, but its outcomes have not been thoroughly investigated.
This randomized controlled trial aims to compare the outcomes of SP simple prostatectomy performed using the da Vinci robotic platform versus thulium laser enucleation of the prostate for the treatment of BPH and BOO.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for patients who have not had success with drug therapy, it's possible that you may need to stop those specific medications.
What data supports the effectiveness of this treatment for enlarged prostate?
Research shows that both Holmium and Thulium laser enucleation are effective for treating enlarged prostate, with benefits like fewer complications and shorter hospital stays compared to traditional surgery. These laser techniques are especially useful for treating large prostates and have become popular alternatives to older methods.
12345Is robotic or laser surgery for enlarged prostate safe?
Both thulium and holmium laser surgeries for enlarged prostate are generally considered safe, with thulium laser showing slightly less blood loss and shorter hospital stays. These techniques have fewer complications compared to traditional methods, making them popular among doctors.
23678How does the treatment of robotic and laser surgery for enlarged prostate differ from other treatments?
Robotic and laser surgeries, like Thulium and Holmium laser enucleation, are unique because they allow for the removal of large prostate tissue with less risk of complications and shorter hospital stays compared to traditional open surgeries. These techniques are particularly effective for treating large prostates and offer an alternative to the standard Transurethral Resection of the Prostate (TURP).
234910Eligibility Criteria
Men with symptomatic Benign Prostatic Hyperplasia (BPH) not relieved by medication are eligible for this trial. It's not open to those who can't consent, prisoners, adults with cognitive impairments, or individuals with coagulopathy (a condition affecting blood clotting).Inclusion Criteria
I have BPH symptoms that didn't improve with medication, so I need surgery.
Exclusion Criteria
I have a cognitive impairment.
I am unable to give consent for medical procedures.
Prisoners
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either SP robotic simple prostatectomy or thulium laser enucleation of the prostate
1 day
1 visit (in-person)
Immediate Postoperative
Participants are monitored for perioperative parameters such as operative time, estimated blood loss, and hospital stay
Up to 30 days
Hospital stay (up to 30 days)
Follow-up
Participants are monitored for safety and effectiveness, including urinary flow rate and quality of life measures
7 months
Multiple visits (in-person and virtual)
Participant Groups
The trial is comparing two surgical approaches for BPH: a new robotic-assisted surgery using the da Vinci single-port platform and traditional thulium laser enucleation. Participants will be randomly assigned to one of these treatments.
2Treatment groups
Active Control
Group I: Single Port Robotic ProstatectomyActive Control1 Intervention
Removal of the prostate using single port robot
Group II: Laser Enucleation of the ProstateActive Control1 Intervention
Enucleation of the prostate with laser surgery
Laser Surgery is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Laser Surgery for:
- Benign Prostatic Hyperplasia (BPH)
- Bladder Outlet Obstruction (BOO)
🇪🇺 Approved in European Union as Laser Surgery for:
- Benign Prostatic Hyperplasia (BPH)
- Bladder Outlet Obstruction (BOO)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UI Health SCB Clinic Department of UrologyChicago, IL
Loading ...
Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
References
A prospective, randomized trial comparing thulium vapoenucleation with holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic obstruction: perioperative safety and efficacy. [2022]To compare the perioperative outcomes of thulium vapoenucleation of the prostate (ThuVEP) with holmium laser enucleation of the prostate (HoLEP) for patients with symptomatic benign prostatic obstruction (BPO).
[Comparison of holmium and thulium laser in transurethral enucleation of the prostate]. [2013]To investigate and compare the effect and safety of Holmium laser and Thulium laser in transurethral enucleation of the prostate in BPH patients.
Current evidence of ThuLEP for BPH: A review of literature. [2022]Endoscopic enucleation of the prostate (EEP) techniques for the treatment of benign prostatic hyperplasia (BPH) have become increasingly popular among urologists over the past 23 years. Despite the energy source employed, the aim of all these procedures is to endoscopically remove the prostatic lobes by enucleating them from the prostate surgical capsule. The reasons for which EEP has gained popularity among urologists are the reduction in complications and hospital stay compared to endoscopic gold standard Transurethral Resection of the Prostate (TURP), but especially the possibility to treat large prostates, allowing to abandon open simple prostatectomy (OP) and to avoid the burden related to open surgery. Holmium laser enucleation of the prostate (HoLEP) sets the basic principles of all EEP techniques in 1998 and has become the treatment of reference for BPH. Since then, various lasers have been developed and applied to prostatic enucleation. The thulium laser has a slightly shorter wavelength compared to the holmium laser and a continuous wave output, which increase vaporization and reduce penetration depth. These features make it ideal for prostatic enucleation. A vapoenucleating technique called Thulium Laser Vapoenucleation of the Prostate was presented in 2009, followed by a blunt enucleating technique called Thulium Laser Enucleation of the Prostate in 2010. These techniques have become alternatives to HoLEP and TURP; however, the amount of literature and randomized controlled trials available are inferior compared to HoLEP. The aim of th describe, and discuss current evidence on thulium enucleating techniques.
Holmium laser enucleation of the prostate versus thulium laser enucleation of the prostate for the treatment of large-volume prostates > 80 ml: 18-month follow-up results. [2021]To compare the perioperative and functional outcomes of holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) for the treatment of large-volume benign prostatic hyperplasia (BPH) (> 80 ml).
[Comparative analysis of the effectiveness of various techniques of endoscopic prostate enucleation in a single center]. [2018]To compare electro- and laser enucleation (thulium, holmium) of prostate hyperplasia.
Comparison of enucleation between thulium laser and holmium laser for benign prostatic hyperplasia: A systematic review and meta-analysis. [2022]To compare the clinical efficacy and safety of Thulium laser enucleation of prostate (ThuLEP) and Holmium laser enucleation of prostate (HoLEP). We systematically searched PubMed, Embase, and Cochrane Library databases within a period from the date of database establishment to October 2020. RevMan 5.4. was used for calculation and statistical analyses. 8 studies of 2125 patients were included. ThuLEP provided less hemoglobin decrease (MD: -0.37, 95%CI -0.61 to -0.14, P = 0.002) and shorter length of hospital stay (MD: -0.41, 95%CI -0.72 to -0.10, P = 0.01). During the postoperative follow-ups, statistically significant differences only were found in IPSS (MD: -0.96; 95%CI -1.27 to -0.65; P
A novel one lobe technique of thulium laser enucleation of the prostate: 'All-in-One' technique. [2019]The thulium laser is the most recently introduced technology for the surgical treatment of benign prostatic hyperplasia (BPH). Until recently, most thulium laser enucleation of the prostate (ThuLEP) was performed by use of the three-lobe technique. We introduce a novel one-lobe enucleation technique for ThuLEP called the "All-in-One" technique. We report our initial experiences here.
Surgical treatment of benign prostatic hyperplasia: Thulium enucleation versus single-port transvesical robotic simple prostatectomy. [2023]The objective of this work is to compare our outcomes using thulium laser enucleation of prostate (ThuLEP) to the single-port robot-assisted simple prostatectomy (SP RASP) in the surgical management of benign prostatic hyperplasia (BPH).
Thulium vapoenucleation of the prostate versus holmium laser enucleation of the prostate for the treatment of large volume prostates: preliminary 6-month safety and efficacy results of a prospective randomized trial. [2019]We compared the perioperative and postoperative characteristics of thulium vapoenucleation and holmium laser enucleation of the prostate for the treatment of large volume benign prostatic hyperplasia.
Laser enucleation for prostates larger than 100 mL: Comparison of HoLEP and ThuLEP. [2021]Recently, with the advancements in laser technology, Holmium laser enucleation of the prostate (HoLEP) and Thulium laser enucleation of the prostate (ThuLEP) have come to the fore in the surgical treatment of benign prostatic hyperplasia (BPH). We aimed to evaluate and compare the outcomes of HoLEP and ThuLEP in patients with >100 ml prostate volume. Patients who underwent HoLEP and ThuLEP between July 2017 and March 2020 were reviewed retrospectively. The patients were divided into two groups as HoLEP (Group 1, n = 121) and ThuLEP (Group 2, n = 104). Perioperative parameters, functional outcomes, continence status, intra and post-operative complications were compared between groups in the post-operative 1st and 6th month. No significant difference was found in terms of total laser energy (TLE), morcellation efficiency (ME), enucleated tissue weight (ETW), complication rates (CR) and continence status of patients between both groups (p > .05). In favour of ThuLEP group, there were statistically significant differences regarding total operation time (TOT), laser efficiency (LE), enucleation time (ET) and enucleation efficiency (EE) between groups (p ≤ .05). HoLEP and ThuLEP can be used safely and effectively in prostates larger than 100 ml.