RecruitingNot ApplicableNCT05686525

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

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

Sponsor

Rigshospitalet, Denmark

Enrollment

220 participants

Start Date

Oct 27, 2022

Study Type

INTERVENTIONAL

Conditions

Prostatic Hyperplasia Lower Urinary Tract Symptoms

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).

Eligibility

Sex: MALEMin Age: 40 Years

Inclusion Criteria7

Ability to understand and the willingness to sign an informed consent.
Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference.
Severe urinary symptoms on IPSS (IPSS score ≥ 20).
Bladder outlet obstruction (BOO) is defined by Qmax ≤ 15ml/sec, based on uroflowmetry.
Prostate volume at minimum 50 ml measured by TRUS or MR.
Men with prostate cancer in Active Surveillance or Watchful Waiting who have LUTS due to a large BPH component are allowed.
Indwelling catheter or intermittent catheter is allowed. In this case baseline IPSS is 35 points.

Exclusion Criteria14

Active bladder cancer (patients with pTa low-grade tumors are allowed).
Previous pelvic radiation for cancer treatment.
Bladder stones (inclusion is allowed after removal).
Current urethral strictures or bladder neck contracture.
Neurogenic LUTS.
Symptomatic urinary tract infection at the time of intervention.
Documented bacterial prostatitis in the last year.
Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist).
Allergy to iodinated contrast media.
Renal failure defined as estimated glomerular filtration rate (eGFR) < 35ml/min.
High bleeding risk (spontaneous international normalized ratio (INR) > 1.6).
Contraindication to conscious sedation (if requested by the patient).
Prostate median lobe defined by treating physician.
Urethral colliculus to bladder neck length <35mm.

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Interventions

PROCEDURETransurethral 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.

PROCEDUREProstate 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.