Actively Recruiting
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
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
The TUMT-PAE-1 trial is a randomised clinical trial aiming to compare the effectiveness of transurethral microwave thermotherapy (TUMT) with prostatic artery embolisation (PAE) in reducing urinary symptoms caused by prostate gland enlargement. The assessment will be done by patient reported and functional outcome measures. The primary purpose is to evaluate the urinary symptoms six months after the procedure, measured by the International Prostate Symptom Score (IPSS).
CONDITIONS
Official Title
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
Who Can Participate
Eligibility Criteria
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
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
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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
Research Team
A
Anna Kristensen-Alvarez, MD
CONTACT
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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