MedTrace Logo

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

NCT05686525 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-01-13

No results posted yet for this study

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).

Conditions

  • Prostatic Hyperplasia
  • Lower 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.

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Andreas Røder, Prof.,MD,PhD · Urological Research Unit, Rigshospitalet

  • Mikkel M Fode, Prof.,MD,PhD · Department of Urology, Herlev-Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05686525 on ClinicalTrials.gov