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Clinical Trials/NCT02566551
NCT02566551
Withdrawn
N/A

Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.

Group of Research in Minimally Invasive Techniques1 site in 1 countryOctober 2015
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ConditionsBenign Prostatic Hyperplasia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Benign Prostatic Hyperplasia
Sponsor
Group of Research in Minimally Invasive Techniques
Locations
1
Primary Endpoint
Improvement of symptoms
Status
Withdrawn
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).

Detailed Description

The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) and the improvement of QoL assessed by QoL questionnaire in patients undergoing prostatic artery embolization (PAE) to patients of similar characteristics undergoing conventional transurethral resection of the prostate (TURP).

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
May 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Group of Research in Minimally Invasive Techniques
Responsible Party
Principal Investigator
Principal Investigator

José A. Guirola, MD

MD

Group of Research in Minimally Invasive Techniques

Eligibility Criteria

Inclusion Criteria

  • •Patients evaluated in the Urology Service because of BPH, candidate to TURP.
  • •Signed informed consent
  • •Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score \> 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI
  • •Patient must meet ONE of the following criteria:
  • •Baseline Prostate Specific Antigen (PSA) \<4 ng/mL (no prostate biopsy required)
  • •Baseline PSA \>4 ng/mL and ≤10 ng/mL AND free PSA \> 15% of total PSA (no prostate biopsy required)
  • •Baseline PSA \>4 ng/mL and ≤10 ng/mL AND free PSA \<15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
  • •Baseline PSA \>10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

Exclusion Criteria

  • •Active urinary tract infection
  • •Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
  • •Biopsy proven prostate or bladder cancer
  • •The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
  • •Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
  • •Patients with baseline PSA levels \> 10 ng/mL
  • •Patients with baseline PSA levels \>4 ng/mL and \< 10 ng/mL AND free PSA \< 15% of total PSA
  • •Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
  • •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
  • •Allergy to iodinated contrast agents

Outcomes

Primary Outcomes

Improvement of symptoms

Time Frame: 12 months

Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )

Secondary Outcomes

  • Improvement in QoL(12 months)
  • Duration of hospitalization post procedure(3 weeks)
  • Preservation of erectile function(12 months)

Study Sites (1)

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