Robotic vs Laser Surgery for Enlarged Prostate

Overseen By Ruben Sauer, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cognitive impairment, Coagulopathy, others

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

Compensation: Varies

Number of Visits: 31

Duration: 1 day

116 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 3 6 7 8}

How 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). ^{2 3 4 9 10}

Research Team

Simone Crivellaro, MD

Principal Investigator

University of Illinois at Chicago, Department of Urology

Eligibility 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

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)

Treatment Details

Interventions

• Laser Surgery
• Single Port Robotic Surgery

Trial Overview 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.

Participant Groups

Group I: Single Port Robotic Prostatectomy Active Control 1 Intervention

Removal of the prostate using single port robot

Group II: Laser Enucleation of the Prostate Active Control 1 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)

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Findings from Research

Thulium vapoenucleation of the prostate (ThuVEP) and holmium laser enucleation of the prostate (HoLEP) are both safe and effective treatments for benign prostatic obstruction, with similar outcomes in terms of urinary flow improvement and low complication rates among 94 patients studied.

However, ThuVEP showed a significantly lower rate of acute postoperative urinary retention compared to HoLEP (2.1% vs. 15.2%), suggesting it may be a preferable option for reducing this specific complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Netsch, C., Becker, B., Tiburtius, C., et al.[2022]

In a study of 98 BPH patients, both Holmium and Thulium lasers were effective in relieving lower urinary tract symptoms (LUTS) after transurethral enucleation, showing similar improvements in urinary function three months post-surgery.

Thulium laser surgery had a shorter operation time and less blood loss compared to Holmium laser, indicating better hemostatic properties, although Holmium laser provided better anatomical clarity during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of holmium and thulium laser in transurethral enucleation of the prostate]. Shao, Q., Zhang, FB., Shang, DH., et al.[2013]

Endoscopic enucleation of the prostate (EEP) techniques, particularly using thulium lasers, have gained popularity for treating benign prostatic hyperplasia (BPH) due to their reduced complications and shorter hospital stays compared to traditional methods like TURP.

Thulium laser techniques, including Thulium Laser Vapoenucleation and Thulium Laser Enucleation, offer effective alternatives to HoLEP and TURP, although there is less literature and fewer randomized controlled trials supporting their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence of ThuLEP for BPH: A review of literature. Bozzini, G., Berti, L., Maltagliati, M., et al.[2022]

In a study of 116 patients with large-volume benign prostatic hyperplasia (BPH), both holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) significantly improved lower urinary tract symptoms after 18 months, demonstrating high efficacy and safety for both methods.

ThuLEP was found to have shorter operative and enucleation times compared to HoLEP, making it a more efficient option, although both techniques showed similar outcomes in terms of symptom relief and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Zhang, J., Ou, Z., Zhang, X., et al.[2021]

In a study of 693 patients with prostate hyperplasia, both thulium (ThuLEP) and holmium (HoLEP) enucleation techniques showed significant improvements in urinary function after 6 months, establishing them as effective treatment options.

Thulium enucleation was notably quicker than holmium enucleation, with an average procedure time of 77.4 minutes compared to 97.0 minutes for HoLEP, while monopolar enucleation took the longest at 112.9 minutes, indicating a potential advantage in efficiency for the thulium method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative analysis of the effectiveness of various techniques of endoscopic prostate enucleation in a single center]. Enikeev, DV., Glybochko, PV., Alyaev, YG., et al.[2018]

Thulium laser enucleation of the prostate (ThuLEP) is associated with less blood loss and shorter hospital stays compared to Holmium laser enucleation of the prostate (HoLEP), based on a systematic review of 8 studies involving 2125 patients.

Patients undergoing ThuLEP showed a faster improvement in symptoms, as indicated by a significant reduction in the International Prostate Symptom Score (IPSS) at the 3-month follow-up, suggesting better clinical efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of enucleation between thulium laser and holmium laser for benign prostatic hyperplasia: A systematic review and meta-analysis. Meng, C., Peng, L., Li, J., et al.[2022]

The novel 'All-in-One' technique for thulium laser enucleation of the prostate (ThuLEP) demonstrated significant improvements in key parameters for 47 patients with benign prostatic hyperplasia (BPH), including a mean operative time of 82.1 minutes and no major complications.

This technique resulted in a high PSA reduction ratio (0.81) and a low enucleation failure rate (4.3%), indicating its efficacy and effectiveness are comparable to existing methods, while potentially reducing operation time and bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel one lobe technique of thulium laser enucleation of the prostate: 'All-in-One' technique. Kim, YJ., Lee, YH., Kwon, JB., et al.[2019]

In a study of 102 men undergoing surgery for benign prostatic hyperplasia, both thulium laser enucleation of the prostate (ThuLEP) and single-port robot-assisted simple prostatectomy (SP RASP) showed similar improvements in International Prostate Symptom Scores (IPSS), indicating comparable efficacy in symptom relief.

SP RASP had a longer operative time but resulted in significantly lower rates of postoperative stress urinary incontinence compared to ThuLEP, suggesting that while both methods are effective, SP RASP may offer better continence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of benign prostatic hyperplasia: Thulium enucleation versus single-port transvesical robotic simple prostatectomy. Talamini, S., Lai, A., Palmer, C., et al.[2023]

In a study of 94 patients with large volume benign prostatic hyperplasia, both thulium vapoenucleation and holmium laser enucleation showed significant improvements in urinary flow and quality of life at 6 months post-surgery, with no significant differences between the two methods.

Both procedures were found to be safe, with low complication rates and no reoperations required within the 6-month follow-up period, indicating their efficacy in treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Becker, B., Herrmann, TRW., Gross, AJ., et al.[2019]

Both Holmium laser enucleation of the prostate (HoLEP) and Thulium laser enucleation of the prostate (ThuLEP) are safe and effective surgical options for treating benign prostatic hyperplasia (BPH) in patients with prostate volumes greater than 100 ml, based on a study of 225 patients.

ThuLEP demonstrated advantages over HoLEP in terms of total operation time, laser efficiency, enucleation time, and enucleation efficiency, indicating it may be a more efficient option for larger prostates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser enucleation for prostates larger than 100 mL: Comparison of HoLEP and ThuLEP. Kaya, E., Yılmaz, S., Açıkgöz, O., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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]

2. China pubmed.ncbi.nlm.nih.gov

[Comparison of holmium and thulium laser in transurethral enucleation of the prostate]. [2013]

3. Turkey pubmed.ncbi.nlm.nih.gov

Current evidence of ThuLEP for BPH: A review of literature. [2022]

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

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]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Comparative analysis of the effectiveness of various techniques of endoscopic prostate enucleation in a single center]. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of enucleation between thulium laser and holmium laser for benign prostatic hyperplasia: A systematic review and meta-analysis. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

A novel one lobe technique of thulium laser enucleation of the prostate: 'All-in-One' technique. [2019]

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

Surgical treatment of benign prostatic hyperplasia: Thulium enucleation versus single-port transvesical robotic simple prostatectomy. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

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]

10. Germany pubmed.ncbi.nlm.nih.gov

Laser enucleation for prostates larger than 100 mL: Comparison of HoLEP and ThuLEP. [2021]