Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH (NCT05686525) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
Denmark220 participantsStarted 2022-10-27
Plain-language 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).
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 trea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean IPSS of the TUMT and PAE arm 6 months after the procedure