Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: PAE; Device: Gelatin microspheres; Procedure: TURP; Device: Bipolar electrosurgery generator

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50003
    • Hospital Universitario Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

  1. Baseline Prostate Specific Antigen (PSA) <4 ng/mL (no prostate biopsy required)
  2. Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA > 15% of total PSA (no prostate biopsy required)
  3. 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)
  4. 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
• Hypersensitivity to gelatin products
• Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
• Known major iliac arterial occlusive disease or any known condition that catheterization of the prostatic arteries or is a contraindication to embolization, as vasospasm, anatomical variations that imply a risk of embolization, bleeding, prostatic arteries diameter inferior to microcatheter profile, pelvic inflammatory disease
• Contraindication to magnetic resonance imaging
• History of prostatitis in the last 5 years, not totally controlled with medical treatment
• History of pelvic irradiation or radical pelvic surgery
• Coagulation disturbances not normalized by medical treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate artery embolization; Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm	Procedure: PAE; Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.; Other Names: Prostate artery embolization; Prostate arteries embolization; Embolization of the prostate; Prostatic artery embolization; Device: Gelatin microspheres; Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol; Other Names: Embolization microspheres
Active Comparator: Transurethral resection of the prostate; Transurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP	Procedure: TURP; Bipolar transurethral resection of the prostate; Other Names: Transurethral resection of the prostate; Transurethral prostatic resection; Device: Bipolar electrosurgery generator; A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP); Other Names: Transurethral prostatic resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of symptoms	Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in QoL	Improvement (change) of quality of life assessed by QoL score	12 months
Duration of hospitalization post procedure	Number of days of postprocedure hospitalization	3 weeks
Preservation of erectile function	Change from baseline in erectile function using the International Index of Erectile Function (IIEF)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum urinary flow rate	Change from baseline in maximum urinary flow rate (Qmax)	12 months
Post-void residual urinary volume	Change from baseline in post-void residual urinary volume (PVR)	12 months
Detrusor pressure	Change from baseline in detrusor pressure (Pdet)	12 months
Mean prostate volume	Change from baseline in mean prostate volume, as determined by transrectal US	12 months
Structural and morphological changes in MRI	Change from baseline in mean prostate volume, and structural and morphological changes as determined by MRI	12 months
Prostate specific antigen	Change from baseline in prostate specific antigen (PSA)	12 months
Overall adverse events	Overall adverse events	12 months
Procedure related adverse events	Procedure related adverse events	12 months

Collaborators and Investigators

• Sponsor: Group of Research in Minimally Invasive Techniques
• Collaborators: Universidad de Zaragoza; Hospital Clínico Universitario Lozano Blesa
• Investigators: Principal Investigator: Miguel A De Gregorio, PhD, University of Zaragoza. Chairman of Radiology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Prostatic artery embolization; Transurethral resection of the prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: GTM-02