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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01931605
First received: July 4, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: Prostatic arterial embolization using BeadBlock (Terumo)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Procedural Success [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    • 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


Secondary Outcome Measures:
  • success of the procedure : ability to urinate after their catheter [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
    Ablation of Indwelling Urinary Catheter

  • success of the procedure : ability to urinate after their catheter [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    Ablation of Indwelling Urinary Catheter

  • success of the procedure : ability to urinate after their catheter [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
    Ablation of Indwelling Urinary Catheter


Estimated Enrollment: 25
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Embolization procedure
selective prostatic arterial embolization using BeadBlock (Terumo) particules
Device: Prostatic arterial embolization using BeadBlock (Terumo)
Selective Prostatic arterial embolization using BeadBlock (Terumo)particuls

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931605

Contacts
Contact: Romain CAREMEL, MD +3323288 ext 0430 romain.caremel@chu-rouen.fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Romain CAREMEL, MD    +3323288 ext 0430    romain.caremel@chu-rouen.fr   
Principal Investigator: Romain CAREMEL, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Romain CAREMEL, MD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01931605     History of Changes
Other Study ID Numbers: 2012/173/HP
Study First Received: July 4, 2013
Last Updated: June 17, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014