RecruitingNAINTERVENTIONAL

HoLEP-ThuLEP - Comparing Lasers for BPH Surgery

This study, called the HoT-Trial, is looking at two types of laser surgery for an enlarged prostate, a common condition called BPH. These surgeries are called HoLEP and ThuLEP. HoLEP is currently a standard treatment, and ThuLEP is a newer option that might offer more precise cutting and less bleeding during the operation. This trial wants to find out if ThuLEP is as good as HoLEP in improving symptoms like needing to pee often or having a weak pee stream. Researchers will also compare recovery times, side effects, and how these surgeries affect things like continence (bladder control) and sexual function. By comparing these two methods directly, the study hopes to help men and their doctors decide on the most suitable surgery for BPH.

At a glance

Status

Recruiting

Phase

Sponsor

Ludwig-Maximilians - University of Munich

Enrolment target

150

Start

01 Jun 2026

Estimated completion

31 Dec 2027

BPH (Benign Prostatic Hyperplasia)

What is this study about?

If you're an older man, you might have heard of or even experienced an enlarged prostate, also known as Benign Prostatic Hyperplasia, or BPH. It's a very common condition where your prostate gland gets bigger. Because it wraps around the tube that carries pee out of your body (the urethra), an enlarged prostate can squeeze it, making it harder to pee. This can lead to symptoms like needing to go to the toilet more often, especially at night, having a weak pee stream, or feeling like you haven't fully emptied your bladder after peeing. When medicines no longer help enough, surgery might be recommended to remove parts of the prostate that are causing the blockage.

This study, called the HoT-Trial, is focused on comparing two modern laser surgeries that tackle this problem: Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation of the Prostate (ThuLEP). HoLEP is well-known and considered a very effective treatment with good long-term results. ThuLEP is a newer technique that uses a different type of laser. Doctors believe ThuLEP might allow for even more precise tissue removal and better control of any bleeding during the surgery. However, we don't have a lot of direct comparisons between these two methods, especially regarding how patients feel and their experiences after the surgery.

The main goal of this study is to see if ThuLEP is just as effective as HoLEP in improving your pee symptoms 12 months after the operation. Researchers will also be looking closely at other important aspects, such as how quickly you recover, whether there are differences in side effects, changes in bladder control, and any impact on sexual function. The findings from this trial will be really helpful for both patients and doctors in deciding which laser surgery might be the best choice for men needing treatment for their enlarged prostate.

Key takeaways

This study compares two laser surgeries (HoLEP and ThuLEP) for an enlarged prostate (BPH).
It aims to find out which surgery is better for pee symptoms, recovery, and side effects.
Participants will be randomly assigned to one of the two standard surgeries.
You'll have follow-up appointments for up to 12 months after surgery.
The study helps doctors and patients choose the most suitable treatment.
There are no extra risks beyond the standard surgeries themselves.

Who may be eligible?

This study is looking for men aged 18 or older who have an enlarged prostate (BPH) that's causing problems with peeing and who require surgery. Your symptoms, measured by a special score called IPSS, should be 8 or higher, and your prostate should be larger than 40 millilitres.

However, you won't be able to join if you have prostate cancer or if it's suspected. You also can't take part if you've had prostate or urethra surgery before. If you have a nerve condition affecting your bladder, or if you're taking blood-thinning medicines that can't be safely stopped for surgery, you also unfortunately can't join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Do you have an enlarged prostate (BPH) that requires surgery?
Are your peeing symptoms bothering you, with a score of 8 or higher on a symptom questionnaire?
Is your prostate larger than 40ml?
Do you not have prostate cancer?
Have you never had prostate or urethra surgery before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be assessed to make sure you meet all the criteria. Once you're in, you'll be randomly assigned to receive either the ThuLEP or HoLEP laser surgery. Neither you nor the medical staff will know which surgery you're getting until just before the operation. Both types of surgery are standard treatments already used in hospitals.

Before your surgery, you'll complete some forms about your pee symptoms, bladder control, and sexual function. You'll also have tests to measure your pee flow and check for any pee left in your bladder after peeing. After the surgery, you'll have follow-up visits at the hospital when you leave, and then again at 3, 6, and 12 months. At these appointments, you'll repeat the same questionnaires and tests to track your progress. The total time you'd be involved in the study, including all follow-ups, would be about 12 months.

Potential risks and benefits

Taking part in this study means you'll receive one of two established surgical treatments for BPH, both of which are widely recommended. You'll also be closely monitored throughout the study, which could lead to a better understanding of your condition and recovery. The specific benefits of one procedure over the other are what the study aims to uncover. As with any surgery, there are potential risks, such as bleeding, infection, and side effects like changes in bladder control or sexual function, but these are risks associated with the standard surgeries themselves, not extra risks added by being in the study. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Urologische Klinik und Poliklinik, LMU Klinikum
Verified postcode
Munich, Germany· Recruiting

Common questions

What is BPH?

BPH stands for Benign Prostatic Hyperplasia, which means your prostate gland is enlarged but not cancerous. It can cause problems with peeing.

What are HoLEP and ThuLEP?

They are both modern laser surgeries used to treat an enlarged prostate by removing parts of the gland that cause blockage.

Will I know which surgery I'm getting?

No, you won't. This is to ensure fair comparison between the two methods. Doctors won't know until just before your operation either.

How long will I be in the study?

You'll be involved in the study for about 12 months after your surgery, including follow-up appointments.

Are there extra risks from being in the study?

No, the study doesn't add any extra risks beyond those already linked to having HoLEP or ThuLEP surgery as part of standard care.

How to find out more

Yannic Volz, PD Dr. med.

yannic.volz@med.uni-muenchen.de +498944000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.