Actively Recruiting

Phase Not Applicable
Age: 40Years +
MALE
ID05686525

Clinical Trial Comparing Transurethral Microwave Thermotherapy and Prostatic Artery Embolisation for Reducing Severe Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia

Led by Rigshospitalet, Denmark · Updated on 2025-01-13

220

Participants Needed

3

Research Sites

422 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

H

Herlev and Gentofte Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial compares two minimally invasive treatments, transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE), for men with severe lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The study aims to determine if TUMT is not worse than PAE in reducing urinary symptoms six months after treatment, using the International Prostate Symptom Score (IPSS) as the main measure. Both treatments aim to shrink the prostate and relieve symptoms, but their effectiveness has not been directly compared in a randomized clinical trial before. Participants will be randomly assigned to receive either TUMT or PAE. In TUMT, a device that emits microwave energy is inserted through the urethra to heat and reduce prostate tissue, with temperature monitored to ensure safety. PAE involves inserting a catheter into the arteries supplying the prostate to block blood flow, causing the prostate to shrink. Both procedures are done in outpatient settings and aim to improve symptoms by reducing prostate size. During the study, participants will be monitored at multiple points up to five years after treatment to assess urinary symptoms, quality of life, satisfaction, side effects, and the need for additional treatments. Evaluations include patient surveys, urine flow measurements, prostate volume checks, and laboratory tests. The main outcome will be the average symptom score six months post-procedure, with additional follow-ups to understand long-term effects and help guide treatment choices.

CONDITIONS

Official Title

Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent
  • Diagnosis of lower urinary tract symptoms due to benign prostatic hyperplasia not responding to or unsuitable for medical treatment
  • Severe urinary symptoms with International Prostate Symptom Score (IPSS) of 20 or higher
  • Bladder outlet obstruction with maximum urine flow rate (Qmax) 15 ml/sec or less
  • Prostate volume of at least 50 ml measured by ultrasound or MRI
  • Men with prostate cancer under active surveillance or watchful waiting with symptoms mainly from BPH
  • Use of indwelling or intermittent catheter allowed with baseline IPSS of 35 points
Not Eligible

You will not qualify if you...

  • Active bladder cancer (except low-grade pTa tumors)
  • Previous pelvic radiation therapy for cancer
  • Presence of bladder stones (unless removed prior to study)
  • Current urethral strictures or bladder neck contracture
  • Neurogenic lower urinary tract symptoms
  • Symptomatic urinary tract infection at time of treatment
  • Bacterial prostatitis within the past year
  • Severe atheromatous disease or other conditions preventing catheter-based intervention
  • Allergy to iodinated contrast media
  • Renal failure with estimated glomerular filtration rate below 35 ml/min
  • High bleeding risk (INR above 1.6)
  • Contraindication to conscious sedation if required
  • Presence of prostate median lobe as determined by physician
  • Urethral length from colliculus to bladder neck less than 35 mm

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Urological Research Unit, Rigshospitalet

Copenhagen, Copenhagen N, Denmark, 2200

Actively Recruiting

2

Department of Urology, Herlev-Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark, 2900

Actively Recruiting

3

Zealand University Hospital

Roskilde, Denmark, 4000

Actively Recruiting

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Research Team

A

Anna Kristensen-Alvarez, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial.

Anna Kristensen-Alvarez, Mikkel Fode, Hein Vincent Stroomberg...

https://pubmed.ncbi.nlm.nih.gov/39223593