Actively Recruiting
Led by Rigshospitalet, Denmark · Updated on 2025-01-13
220
Participants Needed
3
Research Sites
N/A
Total Duration
R
Rigshospitalet, Denmark
Lead Sponsor
H
Herlev and Gentofte Hospital
Collaborating Sponsor
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
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
A
Anna Kristensen-Alvarez, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Anna Kristensen-Alvarez, Mikkel Fode, Hein Vincent Stroomberg...
https://pubmed.ncbi.nlm.nih.gov/39223593