Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
- Conditions
- PharmacotherapyProstatic Artery EmbolizationMinimally Invasive TreatmentBenign Prostatic Hyperplasia
- Interventions
- Procedure: Prostatic Artery Embolization (PAE)Drug: Pharmacotherapy
- Registration Number
- NCT04245566
- Lead Sponsor
- Dominik Abt
- Brief Summary
This study compares safety and efficacy of prostatic artery embolization and pharmacotherapy in the treatment of lower urinary tract symptoms associated wit benign prostatic hyperplasia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 425
- men ≥45 years of age
- lower urinary tract symptoms assigned to BPH (diagnosis by medical history and physical examination)
- IPSS ≥ 8 points
- QoL ≥ 3 points
- Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml
- informed consent for study participation
- renal impairment (GFR < 30ml/min)
- previous prostatic surgery
- 5-alpha reductase inhibitor (5-ARI) use within 6 mo (or dutasteride within 12 mo) prior to entry, or use of an α-blocker or phytotherapy for BPH within 2 weeks prior to entry
- history or evidence of prostate cancer
- absolute indication for surgical treatment of complications related to BPH (i.e. bladder stones, renal impairment due to bladder outlet obstruction)
- history of neurogenic bladder dysfunction
- not able to complete questionnaires due to cognitive or thought disorders
- language skills insufficient for informed consent and / or completion of questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prostatic Artery Embolization (PAE) Prostatic Artery Embolization (PAE) PAE will be performed as an inpatient or outpatient procedure by interventional radiologists who are familiar with the procedure and according to established techniques. A unilateral femoral sheath is placed in the right common femoral artery under local anaesthesia. The prostatic arterial supply is identified by selective internal iliac arteriography. Prostatic arteries are selectively catheterised and embolised by use of 250-600 μm microspheres . PAE is performed bilaterally if possible and considered successful in the absence of the normal blush of the prostate and stasis of flow in the prostate arteries on angiography after embolisation. Pharmocotherapy Pharmacotherapy Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations. Thus, patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin plus 0.5 mg dutasteride once daily during the complete study follow-up.
- Primary Outcome Measures
Name Time Method International Prostate Symptoms Score (IPSS) 24 months after treatment initiation The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
- Secondary Outcome Measures
Name Time Method International Prostate Symptoms Score (IPSS) 5 year after treatment initiation The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
Self-assessed goal achievement (SAGA) 5 years after treatment initiation SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Maximum urinary stream (Qmax) 5 years after treatment initiation Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Post void residual urine (PVR) 5 years after treatment initiation Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
Prostate volume 5 years after treatment initiation Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Prostate specific antigen (PSA) 5 years after treatment initiation laboratory test
Safety / adverse events 5 year after treatment initiation Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Erectile function 5 year after treatment initiation Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Ejaculatory function 5 years after treatment initiation Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
Need for additional drug treatment, surgical treatment or change of medical treatment assessed 5 years after treatment initiation assessed by patient interviews at follow up visit
Analysis of cost-effectiveness using quality-adjusted life years (QALY) 5 years after treatment initiation One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). To estimate QALY costs will be calculated by calculation of treatment costs, and quality of life will be assessed using the questionnaire EQ-5D. EQ-5D measures five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents self-rate their level of severity for each dimension using a five-level scale. The questionnaire can define 3,125 different health states.