Non-inferiority, Randomised, Open-label Clinical Trial on the Effectiveness of Transurethral Microwave Thermotherapy Compared to Prostatic Artery Embolisation in Reducing Severe Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Urological Research Unit, Rigshospitalet
RECRUITING
Copenhagen
Department of Urology, Herlev-Gentofte Hospital
RECRUITING
Gentofte Municipality
Zealand University Hospital
RECRUITING
Roskilde
Contact Information
Primary
Anna Kristensen-Alvarez, MD
anna.kristensen-alvarez@regionh.dk
+4535456152
Time Frame
Start Date:2022-10-27
Estimated Completion Date:2030-12
Participants
Target number of participants:220
Treatments
Experimental: TUMT
In this arm, patients will undergo Transurethral Microwave Thermotherapy (TUMT) where microwave energy is used to destroy the prostate tissue. TUMT is performed under local anaesthesia. Usually, the patient can be discharged from the hospital on the same day. If the patient cannot be discharged on the same day, he will be admitted to the urological ward. After the treatment, a transurethral catheter is inserted. This will be removed at the physician's discretion when spontaneous voiding is achieved with an acceptable residual volume (in general \<100-150 ml), typically within four weeks.
Experimental: PAE
In this arm, patients will undergo prostate artery embolisation (PAE) where blocking the blood flow to the prostate causes it to shrink. PAE is performed under local anaesthesia. Usually, the patient can be discharged from the hospital on the same day. If the patient cannot be discharged on the same day, he will be admitted to the urological ward. Patients with a permanent catheter prior to PAE will keep the catheter up to four weeks after the procedure.