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

Launched by RIGSHOSPITALET, DENMARK · Jan 13, 2023

Keywords

ClinConnect Summary

The TUMT-PAE-1 trial is a study that is looking at two different treatments for men who have severe urinary problems caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH). The trial is comparing transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) to see which one is more effective in relieving these urinary symptoms. Researchers will assess how well these treatments work by asking participants about their symptoms and measuring their urinary function six months after the procedure.

To be eligible for this trial, participants must be men who have been diagnosed with severe urinary symptoms related to BPH, which have not improved with medication or for whom medication is not suitable. They should have an International Prostate Symptom Score (IPSS) of 20 or higher, indicating significant discomfort. Other key criteria include having a prostate that is at least 50ml in size and experiencing bladder outlet obstruction. Those interested in participating will need to sign an informed consent form and will be closely monitored throughout the study to ensure their safety and gather valuable information about the effectiveness of the treatments.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.