Primary Objective: - To determine the urodynamic effects of PAE on bladder outlet resistance (BOR), Qmax, bladder contractility, and post-void residual (PVR).Secondary Objective(s): - IPSS/QoL scores.- Prostate Volume.- Prostate Specific Antigen…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the urodynamic reduction of bladder outlet
obstruction. Cystometry and urodynamic pressure flow are studied by assessing
the following bladder outlet resistance parameters: Schäfer grade, BOOI
(Bladder Outflow Obstruction Index = Abrams-Griffiths number), and urethral
resistance factor (URA; >29 cm H2O =obstructed).
Secondary outcome
Post treatment IPSS, IPSS/QOL, PV, PSA are presented as means and standard
deviations or medians (interquartile ranges) and are compared to baseline.
Wilcoxon signed-rank tests or a paired t-test are used for statistical
analysis.
Background summary
TURP is the golden standard for the surgical treatment of LUTS refractory to
conservative therapy. PAE is a new promising minimal invasive treatment option.
Urodynamic effects of PAE have not yet been investigated.
Study objective
Primary Objective:
- To determine the urodynamic effects of PAE on bladder outlet resistance
(BOR), Qmax, bladder contractility, and post-void residual (PVR).
Secondary Objective(s):
- IPSS/QoL scores.
- Prostate Volume.
- Prostate Specific Antigen level.
- Duration of hospitalization post procedure
- Duration of post procedure catheterization
- To evaluate overall and procedure related adverse events.
Study design
A prospective non-randomized single-centre study to investigate urodynamic
efficacy
Intervention
30 patients with debilitating LUTS due to BPH, refractory to pharmacotherapy
are selected to undergo angiographic embolization of the prostatic arteries
with microspheres.
Study burden and risks
Previous studies on PAE show no major complications and considerable rates of
clinical improvement (9-13).
Risk involved with the individual study procedures are related to contrast
nephropathy and allergy (CT and DSA), femoral access complications and
non-target embolization.
Based on the safety profile from the literature, we consider the potential
benefit to outweigh the small risks on complications.
In case of no clinical improvement after PAE, patients are still eligible to
undergo the usual therapy (TURP).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Male patients, > 40 years
- Lower urinary tract symptoms (LUTS) secondary to Benign Prostate Hyperplasia (BPH)
- Symptoms refractory tomedical therapy(*-adrenergic antagonist and 5*-reductase inhibitor for at least 6 months), or contraindication to medical therapy.
- Patient must be eligible candidate for Transurethral Resection of the Prostate (TURP)
- IPSS (International Prostate Symptom Score) >18 and QoL >3, or both
- BOR (Bladder Outlet Resistance) Schäfer grade *2
- PV (Prostate Volume) > 30 cm³.
- PVR (Post-Void Residual ) * 100 ml.
- Qmax ( maximum flow rate) * 15 ml/sec.
- Patient has given written Informed consent
Exclusion criteria
1. Active urinary tract infection or prostatitis
2. Suspicion of prostatic carcinoma during urologic work up for LUTS due to BPH.
3. Bladder atonia, acute urinary retention, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc),
4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
5. Cystolithiasis or chronic hematuria within 3 months prior to study treatment
6. History of pelvic irradiation or radical pelvic surgery
7. Use of medication with negative effect on detrusor function.
8. Previous surgical procedures, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate or urethra.
9. Unable to undergo Magnetic Resonance Imaging
10. Allergy to iodinated contrast agents
11. Known upper tract renal disease or GFR * 59
12. Contraindications for angiography according to the UMC Utrecht standard of practice.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47710.041.14 |