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WithdrawnNCT02566551Updated Jul 12, 2019

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

An interventional study of PAE and Gelatin microspheres in Benign Prostatic Hyperplasia, sponsored by Group of Research in Minimally Invasive Techniques. Withdrawn at 1 site in Spain. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Group of Research in Minimally Invasive Techniques · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years and older
Sex
Male
01

Study 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).

Read the 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).

02

Conditions studied

  • Benign Prostatic Hyperplasia

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Keywords

  • Prostatic artery embolization
  • Transurethral resection of the prostate
03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Group of Research in Minimally Invasive Techniques is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Prostate artery embolization

    Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm

    Procedure: PAE · Device: Gelatin 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 · Device: Bipolar electrosurgery generator

Interventions

  • ProcedurePAE

    Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.

    Also known as: Prostate artery embolization, Prostate arteries embolization, Embolization of the prostate, Prostatic artery embolization

  • DeviceGelatin microspheres

    Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol

    Also known as: Embolization microspheres

  • ProcedureTURP

    Bipolar transurethral resection of the prostate

    Also known as: Transurethral resection of the prostate, Transurethral prostatic resection

  • DeviceBipolar electrosurgery generator

    A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)

    Also known as: Transurethral prostatic resection

06

What researchers measure

Primary outcomes

  1. Improvement of symptoms

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

    Time frame: 12 months

Secondary outcomes

  1. Improvement in QoL

    Improvement (change) of quality of life assessed by QoL score

    Time frame: 12 months

  2. Duration of hospitalization post procedure

    Number of days of postprocedure hospitalization

    Time frame: 3 weeks

  3. Preservation of erectile function

    Change from baseline in erectile function using the International Index of Erectile Function (IIEF)

    Time frame: 12 months

Other outcomes

  1. Maximum urinary flow rate

    Change from baseline in maximum urinary flow rate (Qmax)

    Time frame: 12 months

  2. Post-void residual urinary volume

    Change from baseline in post-void residual urinary volume (PVR)

    Time frame: 12 months

  3. Detrusor pressure

    Change from baseline in detrusor pressure (Pdet)

    Time frame: 12 months

  4. Mean prostate volume

    Change from baseline in mean prostate volume, as determined by transrectal US

    Time frame: 12 months

  5. Structural and morphological changes in MRI

    Change from baseline in mean prostate volume, and structural and morphological changes as determined by MRI

    Time frame: 12 months

  6. Prostate specific antigen

    Change from baseline in prostate specific antigen (PSA)

    Time frame: 12 months

  7. Overall adverse events

    Overall adverse events

    Time frame: 12 months

  8. Procedure related adverse events

    Procedure related adverse events

    Time frame: 12 months

07

Study locations

1 site
  • Hospital Universitario Lozano Blesa
    Zaragoza, 50003, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2015 (actual). Primary completion is estimated for May 2018, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2015
First posted
Oct 2, 2015
StartActual
Oct 2015
Primary completionEst.
May 2018
CompletionEst.
May 2019
Last update
Jul 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02566551
Lead sponsor
Group of Research in Minimally Invasive Techniques
Collaborators
Hospital Clínico Universitario Lozano Blesa, Universidad de Zaragoza
Responsible party
José A. Guirola, MD (MD, Group of Research in Minimally Invasive Techniques) — Principal investigator
First posted
Oct 2, 2015
Start date
Oct 2015
Primary completion
May 2018 (estimated)
Completion
May 2019 (estimated)
Last update
Jul 12, 2019

Study contacts

Miguel A De Gregorio, PhD
principal investigator · University of Zaragoza. Chairman of Radiology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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