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Compares treatment options for Prostatic Hyperplasia
Official title Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
ClinicalTrials.gov ID: NCT05686525
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Copenhagen N, Denmark
- Gentofte Municipality, Hellerup, Denmark
- Roskilde, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Copenhagen N, Denmark; Gentofte Municipality, Hellerup, Denmark; Roskilde, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.