Embolisation of the prostatic artery in patients with symptomatic benign prostate hyperplasia: A prospective single arm cohort-study.

Embolisation of the prostatic artery in patients with symptomatic benign prostate hyperplasia: A prospective single arm cohort-study. - EMBO-PROST

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52683

Enrollment

Registered

2019-02-14

Start date

2019-08-29

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign prostate hypertrofia benign prostate tumour

Interventions

After out-patient urology consultation and informed consent, patients undergo in-patient PAE. Before PAE all patients have blood examination (GFR, CBC, creat, PSA, coagulation status) and corrected

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: men > 40 years with urinary tract symptoms due to BPH, refractory to medical therapy prostate size > 50cc measured by trans-rectal US and/or CT and MRI IPSS score>18 Qol >2 Qmax

Exclusion criteria

Exclusion criteria: Prostate/bladder malignancy neurogenic bladder detrusor failure hyper-/hypoactive bladder urethral strictures dysfunction/contraction bladder neck bladder calculi of diverticula renal insufficiency (GFR

Design outcomes

Primary

Measure	Time frame
To assess the effect (Δ IPSS) after 3 months of prostate artery embolization (PAE) with polyethylene glycol microspheres (PEGM) in patients with low urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH).	—

Secondary

Measure	Time frame
Secondary parameters - Assessment safety defined as adverse events: o expected side-effects: * e.g. pelvic pain, worsening of direct obstructive and irritative symptoms, extension of inflammatory effect to adjacent symptoms, transient increase urinary frequency, burning urethral pain. o unexpected complications: * e.g. vascular complication, non-targeted embolization, erectile dysfunction, incontinence, retrograde ejaculation, urinary tract infection, bladder necrosis, (acute) urinary retention, hematuria, rectorrhagia, hematospermia, radiodermatitis, skincancer. - Assessment during 12 months follow up; Δ IPSS, Δ prostate volume (PV), Δ prostate specific antigen (PSA), Δ post void residual urine volume (PVR), Δ Qmax, Δ IPSS, Δ erectile function score (IIEF) and Δ quality of life (Qualeffo). - PAE costs - Assessment of predictors of good clinical outcome e.g. Zonal Volumetry index, number of nodules >= 2, percentage necrosis on MRI and Δ Exploratory parameters The off-line evaluation of the clinical performance of Philips EmboGuide in PAE procedures (EmboGuide will not be used during all procedures) a. Parameters related to the use of XperCT and EmboGuide: i. Procedure time (defined as time between first exposure run and last exposure run) ii. Successful detection of prostatic artery (First time right, Manual correction needed, Failed to detect) iii. Accumulative procedure dose (Total DAP in Gy.cm2 )	—

Measure

Time frame

Secondary parameters - Assessment safety defined as adverse events: o expected side-effects: * e.g. pelvic pain, worsening of direct obstructive and irritative symptoms, extension of inflammatory effect to adjacent symptoms, transient increase urinary frequency, burning urethral pain. o unexpected complications: * e.g. vascular complication, non-targeted embolization, erectile dysfunction, incontinence, retrograde ejaculation, urinary tract infection, bladder necrosis, (acute) urinary retention, hematuria, rectorrhagia, hematospermia, radiodermatitis, skincancer. - Assessment during 12 months follow up; Δ IPSS, Δ prostate volume (PV), Δ prostate specific antigen (PSA), Δ post void residual urine volume (PVR), Δ Qmax, Δ IPSS, Δ erectile function score (IIEF) and Δ quality of life (Qualeffo). - PAE costs - Assessment of predictors of good clinical outcome e.g. Zonal Volumetry index, number of nodules >= 2, percentage necrosis on MRI and Δ Exploratory parameters The off-line evaluation of the clinical performance of Philips EmboGuide in PAE procedures (EmboGuide will not be used during all procedures) a. Parameters related to the use of XperCT and EmboGuide: i. Procedure time (defined as time between first exposure run and last exposure run) ii. Successful detection of prostatic artery (First time right, Manual correction needed, Failed to detect) iii. Accumulative procedure dose (Total DAP in Gy.cm2 )

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)