Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.
Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.
Background: Patients with indwelling urinary catheter for chronic retention due to
 obstructive BPH refractory to medical therapy are candidates for prostatectomy still
 considered as the gold standard of treatment. Urinary tract infection, strictures,
 postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss
 are complications associated with surgery. Minimally invasive treatments were originally
 conceived as an attempt to offer equivalent efficacy without the burden and risk of operative
 morbidity. Recently, it was suggested that prostatic arterial embolization (PAE) to treat BPH
 might follow uterine artery embolization for uterine leiomyomas. Animal studies in pigs and
 dogs have shown that PAE is safe and can induce prostatic volume reduction. The first report
 of this technique in the management of BPH in humans was by DeMeritt et al, who reported a
 single case of BPH with obstructive symptoms and blood loss refractory to other treatments
 that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.

 Objective : We investigate whether PAE might be a feasible procedure as an alternative
 treatment option to treat urinary retention due to obstructive BPH. The primary objective is
 to evaluate the success rate of procedure defined when selective prostatic arterial
 catheterization and embolization were achieve and patients can be able to urinate after their
 urinary catheter has been removed.

 Patients and methods : A monocentric prospective study is undertaken in 25 patients aged
 50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory to
 medical treatment with a clinical indication for surgery who agreed to undergo PAE. The study
 is approved by the hospital ethical committee and an informed consent form for PAE as an
 alternative treatment is signed by all participants.

 Statistical analysis : The sample size has been calculated in order to have an estimated
 probability of success (corresponding of primary objective) of 50% (worst case) with 95%
 confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used
 to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally,
 the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is
 indicative of statistically significant.
Embolization is performed under local anesthesia in one day surgery unit by unilateral
 approach, usually the right femoral artery. Initially, pelvic angiography is performed to
 evaluate the iliac and prostatic arteries. Then, a 5-F catheter is introduced in right
 femoral artery to catheterize the left hypogastric artery and reach its anterior division.
 The inferior vesical artery and finally the prostatic vessels are selectively catheterized
 with a 3-F coaxial microcatheter. For embolization, nonspherical 100-300 μm PVA particles is
 used. The endpoint chosen for embolization is slow flow or near-stasis in the prostatic
 vessels with interruption of the arterial flow and prostatic gland opacification. When
 embolization of the left prostatic arteries was finished, the right prostatic arteries were
 embolized in the same way.

 Urinary catheter is removed 10 days after the embolization procedure. Voiding trials is
 performed and the successfull urination after urethral catheter removal is defined as three
 consecutive spontaneous micturitions with postvoid residual less than 100% of each
 micturition volume. If the patient is unable to urinate, a urethral catheter will replace
 before hospitalization discharge and the patient will return to our outpatient clinic for
 another voiding trial until the end of protocol. Assessments were carried out 10, 30 and 90
 days after initial embolization allocation.
Inclusion Criteria:

 -  Patients with a urinary retention due to obstructive benign prostatic hyperplasia
 (BPH) confirmed by endoscopy,

 -  Patients aged 50-85 years,

 -  Patients with indwelling urinary catheter for at least 1 month,

 -  Patients with at least one failure of a trial without catheter despite alpha-blocker
 treatment for at least 72 hours,

 -  Patients informed about alternative treatment (transurethral resection of the
 prostate, laser prostatectomy, prostatic adenomectomy),

 -  Patients signed an informed consent form.

 Exclusion Criteria:

 -  Prostate cancer (evaluated by PSA, physical examination, in all patients and by
 prostatic biopsy in suspicious cases).

 -  History of relevant neurological disease (e.g. multiple sclerosis, spinal cord injury,
 parkinson's disease).

 -  Patients who have on urodynamic investigation evidence of an atonic bladder.

 -  Urethral stricture

 -  Chronic persistent local pathology that may cause urinary symptoms (e.g. interstitial
 cystitis, tumor, bladder stone).

 -  Renal insufficiency stade 3 or 4 (creatinine clearance < 35 mL/min)

 -  Any allergy or contraindication to ciprofloxacin or drugs used in this protocole
 (xylocaine, Atarax, paracetamol, and nonsteroidal anti-inflammatory drug)

 -  Any allergy to intravenous contrast agent or iodine

 -  Thyrotoxicosis

 -  Concomitant use of tizanidine

 -  Patients participating to another research protocol