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RECRUITING
NCT05686525
NA

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

MALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2022-10-27

Completion Date

2030-12

Last Updated

2025-01-13

Healthy Volunteers

No

Interventions

PROCEDURE

Transurethral Microwave Thermotherapy

TUMT is performed by a urologist and/or a trained urological nurse. In TUMT a specially designed instrument that sends out microwave energy is inserted inside the prostate through the urethra. Cooling fluid circulates the instrument to prevent heat from damaging the wall of the urethra. To prevent the temperature from getting too high outside the prostate a temperature sensor is inserted into the patient's rectum and at the penoscrotal angle. If the temperature reaches the safety limit the microwave generator's output will be shut off automatically. Microwave is then used to heat the prostate (preferably to 50-60 degrees Celsius) and destroy hyperplastic prostate tissue. As the prostate heals it will shrink and reduce the blockage of urine flow and the symptoms of BPH.

PROCEDURE

Prostate Artery Embolisation

In PAE an interventional radiologist will insert a small catheter into the vessels that supply blood to the prostate. An arteriogram is done to map the blood vessels feeding the prostate. Tiny embolization particles are injected through the catheter and into the blood vessels to reduce the blood supply to the prostate. This procedure is intended bilaterally at both sides of the prostate. Following the procedure, the prostate will begin to shrink reducing the symptoms of BPH.

Locations (3)

Urological Research Unit, Rigshospitalet

Copenhagen, Copenhagen N, Denmark

Department of Urology, Herlev-Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Zealand University Hospital

Roskilde, Denmark