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

Recruiting now · Not applicable

Conditions studied: Prostatic Hyperplasia, Lower Urinary Tract Symptoms

In brief

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).

Key facts

Study ID

NCT05686525

Run by

Rigshospitalet, Denmark

People needed

220

Starts

2022-10-27

Expected to finish

2030-12-01

Last updated by the study team

2025-01-13

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Urological Research Unit, Rigshospitalet — Copenhagen, Copenhagen N, Denmark (enrolling)
• Department of Urology, Herlev-Gentofte Hospital — Gentofte Municipality, Hellerup, Denmark (enrolling)
• Zealand University Hospital — Roskilde, Denmark (enrolling)

Full record on ClinicalTrials.gov

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