Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.

NCT01931605 | Terminated Phase 3 DMC

• 1 other identifier: 2012/173/HP
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Procedural Success

  * Procedural success was defined as cessation of extravasation and/or occlusion of the targeted vessel on postembolization arteriography. * Voiding diary : mictirution volume and postvoid residual volume measurements by ultrasonography

  Day 1

Secondary Outcomes (3)

• success of the procedure : ability to urinate after their catheter

  Day 10

• success of the procedure : ability to urinate after their catheter

  Day 90

• success of the procedure : ability to urinate after their catheter

  Day 30

Study Arms (1)

Embolization procedure

EXPERIMENTAL

selective prostatic arterial embolization using BeadBlock (Terumo) particules

Device: Prostatic arterial embolization using BeadBlock (Terumo)

Interventions

Prostatic arterial embolization using BeadBlock (Terumo) DEVICE

Selective Prostatic arterial embolization using BeadBlock (Terumo)particuls

Embolization procedure

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Romain CAREMEL, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: August 29, 2013
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (1)