Active not recruitingNAINTERVENTIONAL

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

This research trial, called WATER III, is looking at two ways to treat an enlarged prostate (BPH) that causes frustrating urinary symptoms. These treatments are Aquablation and a type of laser surgery. It's for men whose prostates are quite large, between 80ml and 180ml. The main goal is to find out which treatment is more effective at relieving symptoms and is also safer for patients. By comparing these two methods, doctors hope to gain a clearer understanding of the best approach for men with larger prostates to help them live more comfortably and improve their quality of life. Participants would be randomly assigned one of the two treatments.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Bonn

Enrolment target

202

Start

16 Dec 2020

Estimated completion

01 Oct 2029

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

What is this study about?

This study, called WATER III, is designed to compare two different ways of treating a common condition known as Benign Prostatic Hyperplasia, or BPH. This is when the prostate gland, which is usually quite small, gets bigger as men get older. A large prostate can press on the tube that carries urine out of the body (the urethra), leading to uncomfortable symptoms like needing to pee often, having a weak flow, or difficulty emptying the bladder.

The trial is focusing on men with particularly large prostates, specifically those between 80ml and 180ml. Doctors want to see if a newer treatment called Aquablation is as good as, or even better than, a more established treatment called transurethral laser enucleation. Aquablation uses water jets to remove prostate tissue, while laser enucleation uses a laser to achieve a similar goal.

The main aim is to carefully check both treatments to see how well they work at improving urinary symptoms and how safe they are for patients. By taking part, you would help doctors understand which method might be best for men with larger prostates, helping future patients get the most effective and safest care possible. This is important because finding the right treatment can significantly improve daily life for men with BPH.

Key takeaways

Compares two surgical treatments for enlarged prostates (BPH).
Aims to find the safest and most effective method.
For men aged 45-80 with larger prostates (80-180ml).
You would receive either Aquablation or laser surgery.
Careful monitoring of your health and symptoms.
Helps improve care for future patients with BPH.

Who may be eligible?

To join this study, you would generally need to be a man between 45 and 80 years old, experiencing significant urinary problems due to an enlarged prostate. Your prostate would need to be measured by ultrasound and found to be between 80ml and 180ml in size. You should also be able to understand what the study involves and be willing to sign a consent form, as well as be able to attend all planned appointments.

There are also some reasons why you might not be able to join. For example, if you have a very high Body Mass Index (BMI of 42 or more), or if there's any suspicion or history of prostate or bladder cancer. Other reasons include having bladder stones, a长期尿管, a recent urinary infection, or issues like a narrowed urethra. If you've had certain other prostate or bladder operations, or take blood-thinning medicines that can't be stopped, you might also not be suitable.

Doctors will also consider if you have any other health conditions or life situations that could make it difficult for you to take part safely or complete the study. Your ability to give consent and understand the trial is crucial. They will also check if you are participating in another urology trial or have known issues with substance abuse.

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 between 45 and 80 years old?
Do you have moderate to severe urinary symptoms due to an enlarged prostate?
Has your prostate been measured as 80-180ml?
Have you *not* had prostate or bladder cancer?
Are you able to attend all study appointments?
Are you able and willing to sign a consent form?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would be randomly assigned to receive either the Aquablation therapy or the laser enucleation procedure. You would have a series of appointments before and after your treatment. These appointments would involve assessments of your urinary symptoms and general health. The study would keep track of how well your treatment works and check for any side effects over a period of time. You would need to attend all scheduled follow-up visits to ensure your progress is monitored properly. The exact number of visits and the full duration of follow-up would be explained to you in detail.

Potential risks and benefits

Potential benefits of joining this study include receiving an established or innovative treatment for your enlarged prostate, with careful monitoring of your health and symptoms. This could lead to a significant improvement in your urinary problems and overall quality of life. However, there are also potential risks associated with any surgical procedure, including bleeding, infection, and anaesthesia risks. Specific to these treatments, there could be side effects related to changes in urinary function or sexual health, which would be fully discussed with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Department of Urology, University Hospital Freiburg
Verified postcode
Freiburg im Breisgau, Germany
Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
Verified postcode
Bochum, Germany
Department of Urology, University Hospital Bonn
Verified postcode
Bonn, Germany
Frimley Health NHS Foundation Trust
Verified postcode
London, United Kingdom
Guy's and St. Thomas' Hospital
Verified postcode
London, United Kingdom

Common questions

What is BPH?

BPH stands for Benign Prostatic Hyperplasia, which means your prostate gland has grown larger, not due to cancer, and can cause urinary problems.

What is Aquablation?

Aquablation is a newer treatment that uses a high-pressure water jet to remove prostate tissue that's causing problems.

What is laser enucleation?

Laser enucleation is a common surgery for BPH where a laser is used to remove the overgrown parts of the prostate.

Who is this study for?

This study is for men aged 45-80 who have urinary problems from a large prostate (80-180ml) and meet other health requirements.

Will I choose my treatment?

No, if you join, you'll be randomly put into one of the two treatment groups (Aquablation or laser surgery).