Comparing Transurethral Microwave Thermotherapy and Prostatic Artery Embolisation for Treating Severe Urinary Symptoms in Men with Enlarged Prostate
Led by Rigshospitalet, Denmark · Updated on 2025-01-13
220
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating 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. This randomized clinical trial aims to compare the effectiveness of these treatments in reducing urinary symptoms, measured by the International Prostate Symptom Score IPSS six months after the procedures. The study also focuses on patient satisfaction, quality of life, and functional outcomes over the long term.
Participants will be assigned to receive either TUMT, which uses microwave energy to destroy prostate tissue through the urethra under local anesthesia, or PAE, which involves blocking blood flow to the prostate via catheter-guided embolisation, also under local anesthesia. Both procedures are usually outpatient with same-day discharge unless hospital admission is required. Catheters are used post-procedure and are typically removed within four weeks based on individual recovery and physician assessment.
During the study, participants will undergo regular assessments including symptom questionnaires, uroflowmetry tests, prostate volume measurements, blood tests, and monitoring for side effects or complications. Outcomes will be measured at multiple time points 1, 3, 6, 12, 24, and 60 months after treatment. Researchers will evaluate urinary symptoms, quality of life, sexual function, catheter use, and the need for re-treatment. The study plans to include 220 men aged 40 years or older and will monitor safety and efficacy through these detailed follow-ups.
CONDITIONS
Brief Title
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
Research Team
A
Anna Kristensen-Alvarez, MD
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Ability to understand and willing to sign informed consent
Diagnosis of lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to or contraindicated for medical treatment or by patient preference
Severe urinary symptoms with IPSS score of 20 or higher
Bladder outlet obstruction with maximum urine flow rate (Qmax) of 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 LUTS due to large BPH component allowed
Use of indwelling or intermittent catheter allowed with baseline IPSS of 35 points
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)
Current urethral strictures or bladder neck contracture
Neurogenic lower urinary tract symptoms
Symptomatic urinary tract infection at time of intervention
Bacterial prostatitis documented in last 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 with INR greater than 1.6
Contraindication to conscious sedation if required
Prostate median lobe as defined by physician
Urethral colliculus to bladder neck length less than 35 mm
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of procedure with possible hospital admission up to 1 day
Participants undergo either Transurethral Microwave Thermotherapy (TUMT) or Prostatic Artery Embolisation (PAE), minimally invasive outpatient procedures to reduce symptoms of benign prostatic hyperplasia.
1 treatment visit (in-person)
Post-treatment Follow-up
Duration - Up to 5 years post-procedure
Participants have follow-up visits to monitor treatment effects, side effects, and collect patient-reported outcomes including quality of life and urinary function.
Multiple visits at 1, 3, 6, 12, 24, and 60 months post-procedure
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...