Status:
RECRUITING
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Herlev and Gentofte Hospital
Conditions:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
40+ years
Phase:
NA
Brief 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 sym...
Detailed Description
One fourth of men older than 70 years have moderate to severe lower urinary tract symptoms (LUTS) that impair their quality of life (QOL). This is most frequently caused by benign prostatic hyperplasi...
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.
Key Trial Info
Start Date :
October 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05686525
Start Date
October 27 2022
End Date
December 1 2030
Last Update
January 13 2025
Active Locations (3)
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1
Urological Research Unit, Rigshospitalet
Copenhagen, Copenhagen N, Denmark, 2200
2
Department of Urology, Herlev-Gentofte Hospital
Gentofte Municipality, Hellerup, Denmark, 2900
3
Zealand University Hospital
Roskilde, Denmark, 4000