50 Participants Needed

Thulium vs. Holmium Laser for Enlarged Prostate

IM
SD
Overseen BySmita De, MD, PHD
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?

This trial compares two laser treatments, thulium and holmium, to determine which is more effective for treating an enlarged prostate (benign prostatic hyperplasia or BPH). Both lasers are already in use due to fewer complications compared to older methods, but the study aims to identify if one is superior. Men with an enlarged prostate who haven't undergone previous prostate surgery may be suitable candidates for this trial. As an unphased trial, it provides an opportunity to contribute to understanding which laser treatment benefits future patients more effectively.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants (blood thinners) or antiplatelets (medications that prevent blood clots) before surgery and for up to one week after surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a thulium laser to treat an enlarged prostate (ThuLEP) is safe. Studies have found it effective, with minimal blood loss, and suitable for prostates of various sizes. Although it may take longer for larger prostates, it remains a reliable option. Another study confirmed that ThuLEP and similar methods are safe and effective even for very large prostates.

The holmium laser treatment (HoLEP) also maintains a strong safety record. Both the American Urological Association and other experts recommend it for treating an enlarged prostate. It results in fewer complications compared to older methods like the transurethral resection of the prostate (TURP).

In summary, both treatments have proven to be safe and effective for prostate issues, with few complications.12345

Why are researchers excited about this trial?

Researchers are excited about Thulium Laser Enucleation of the Prostate because it offers a potentially more precise and efficient method for treating an enlarged prostate compared to current laser options like Holmium. Thulium lasers operate at a different wavelength, which might allow for better cutting precision and reduced bleeding during the procedure. This could lead to shorter recovery times and fewer complications for patients, making it a promising alternative to existing treatments.

What evidence suggests that this trial's treatments could be effective for enlarged prostate?

This trial will compare Thulium Laser Enucleation of the Prostate with Holmium Laser Enucleation of the Prostate for treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Research has shown that both thulium and holmium laser treatments are effective. Participants in the thulium laser arm may experience effective treatment with minimal blood loss and rapid removal of prostate tissue, significantly improving quality of life. Meanwhile, participants in the holmium laser arm receive a treatment recommended by the American Urological Association for its long-term effectiveness and fewer complications compared to traditional surgery. Both treatments work well regardless of prostate size, making these laser treatments promising options for managing BPH effectively.12678

Are You a Good Fit for This Trial?

This trial is for men over 18 with an enlarged prostate who haven't had previous prostate surgery. They must be able to understand and sign a consent form, and can't have bladder stones needing laser removal or be unable to stop blood thinners as per surgery protocols.

Inclusion Criteria

I am a male over 18 with a prostate.
I have not had prostate surgery.
Understand and voluntarily sign an informed consent form

Exclusion Criteria

I cannot or will not give my consent to participate.
I have had surgery on my prostate before.
I do not need laser surgery for bladder stones, unless it's a small stone that can be removed whole.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Thulio or Holmium laser enucleation of the prostate

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
Trial Overview The study compares two types of lasers used in prostate surgery: pulsed thulium laser and holmium laser. It aims to determine which one is more effective for treating benign prostatic hyperplasia (BPH), considering success rates and complications.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental - ThulioExperimental Treatment1 Intervention
Group II: Control - HolmiumActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Smita De

Lead Sponsor

Citations

Thulium laser enucleation of the prostate is a safe and ...Thulium LASER is a safe and highly effective LASER in terms of blood loss, speed of tissue resection, drop in serum PSA, and versatility of prostatic resection.
Comparative outcomes of thulium laser enucleation by ...ThuLEP demonstrated excellent safety and efficacy in treating BPE, regardless of prostate size. Larger prostates required longer operative times.
A Comparative Study of the Efficacy of Thulium Fiber Laser...ThuFLEP demonstrated efficacy similar to TURP in medium- to larger-size BPH in terms of IPSS and Q max but had significant improvement in QoL scores.
Lasers for Benign Prostatic Obstruction: And the Winner Is …One of the main drawbacks of laser enucleation is postoperative urinary incontinence, which affects up to 15% of patients at 1 mo, and decreases ...
A prospective analysis of thulium laser enucleation in ...Both high-power and low-power thulium laser enucleation could provide comparable results apropos bladder outlet obstruction due to BPH. Data ...
A comparison between thulium fiber laser enucleation of ...Conclusion. Both ThuFLEP and RASP are safe techniques with comparable functional outcomes for large benign prostatic hyperplasia. ThuFLEP allows a reduction in ...
The safety and efficacy of five surgical treatments in prostate ...In brief, our findings suggest that ThuLEP only presents marginal advantages over HoLEP in terms of short-term outcomes, while ThuFLEP ...
Efficacy and Safety of Thulium Laser Vaporization of the ...Our data confirm ThuVAP as an effective and safe treatment for BPH. 1 Introduction. According to the American Urological Association guidelines, ...
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