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

NARecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

October 27, 2022

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Prostatic HyperplasiaLower Urinary Tract Symptoms
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.

Trial Locations (3)

2200

RECRUITING

Urological Research Unit, Rigshospitalet, Copenhagen

2900

RECRUITING

Department of Urology, Herlev-Gentofte Hospital, Gentofte Municipality

4000

RECRUITING

Zealand University Hospital, Roskilde

All Listed Sponsors
collaborator

Herlev and Gentofte Hospital

OTHER

lead

Rigshospitalet, Denmark

OTHER