Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Transurethral Microwave Thermotherapy
- Prostate Artery Embolisation
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Herlev and Gentofte Hospital
Collaborator
Source ClinicalTrials.gov