Benign Prostatic Hyperplasia, Pharmacotherapy, Prostatic Artery Embolization, Minimally Invasive Treatment
Conditions
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.
Interventions
PROCEDUREProstatic Artery Embolization (PAE)
Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
DRUGPharmacotherapy
Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations
Sponsors
Dominik Abt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomized controlled study
Eligibility
Sex/Gender
MALE
Age
45 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Self-assessed goal achievement (SAGA) | 6 weeks 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) | 6 weeks 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) | 6 weeks 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 | 6 moths 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) | 6 months after treatment initiation | laboratory test |
| International Prostate Symptoms Score (IPSS) | 6 weeks 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. |
| Erectile function | 6 weeks 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 | 6 weeks 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 | 6 weeks after treatment initiation | assessed by patient interviews at follow up visit |
| Analysis of cost-effectiveness using quality-adjusted life years (QALY) | 2 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. |
| Safety / adverse events | 6 weeks after treatment initiation | Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE. |
Contacts
Primary ContactDominik ABT, MD
Outcome results
None listed