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NCT Number: NCT02167919

Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)

Purpose: To evaluate the efficacy of prostatic artery embolization (PAE) in patients with benign prostatic hyperplasia (BPH) and refractory lower urinary tract symptoms (LUTS) in decreasing the volume of the prostate gland.

Participants: Study participants will be recruited from UNC Urology clinics as well as referring providers. We will include 15 men who are experiencing LUTS not controlled by medication with estimated prostate gland weight between 80 and 150 grams.

Procedures (methods): Enrolled patients will undergo the standard work-up for a surgical prostate procedure. In addition, the patient's arteries will be evaluated with a pelvic CT angiogram. Then, patients will undergo prostatic artery embolization. Follow up visits will be scheduled at 1, 3, 6, and 12 months after the procedure.

At the end of the follow-up period, if reduction in prostate gland size has made the patient eligible for transurethral therapy, they may proceed to such procedure or elect to undergo no further surgical procedure, depending on residual symptoms. Similarly, if insufficient gland size reduction has occurred, the patient may elect to pursue OP or no further procedure if they are no longer bothered by LUTS.

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Key information

Conditions

Benign Prostatic Hyperplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Hyperplasia Male Urogenital Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

About this study

This will be an open label pilot study with a small population undergoing an intervention to determine safety and efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age > 40
  • Prostate gland measures between 80 and 150 grams
  • Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
  • Moderate to severe LUTS as defined by IPSS score >18
  • Peak urine flow rate (Qmax) <12 ml/sec
  • Capable of giving informed consent
  • Life expectancy greater than 1 year

Exclusion criteria

  • Severe cardiac or pulmonary disease
  • Uncontrolled diabetes mellitus
  • Immunosuppression
  • Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
  • Acute urinary retention
  • Glomerular filtration rate less than 45 as approximated using using serum creatinine levels.
  • Confirmed or suspected bladder cancer
  • Recent (within 3 months) cystolithiasis or gross hematuria
  • Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
  • Active urinary tract infection
  • Previous rectal surgery or history of rectal disease if PAE, anoscopy or transrectal ultrasound are thought to potentially cause injury to the rectum due to the previous surgery or disease
  • Previous pelvic radiation or radical pelvic surgery
  • Confirmed or suspected malignancy of the prostate based on DRE, TRUS or PSA. (> 10 ng/ml or > 2.5 ng/ml and < 10 ng/ml with free PSA < 25% of total PSA without a negative biopsy)
  • Uncorrectable coagulopathy including INR > 2.5 or platelets < 30,000

Treatment and study plan

Microspheres

Device

Prostatic artery embolization (PAE) is a new procedure that decreases the size of the prostate by blocking its arterial blood flow. Through a tiny puncture in the upper thigh or forearm a catheter is directed to the prostatic artery using fluoroscopic guidance. Once in place, sub-millimeter particles are injected that obstruct the prostatic arteries resulting in gland ischemia, and ultimately, reduction in size. The technique has only been recently developed in Portugal and Brazil and has similarities to Uterine Artery Embolization used to treat uterine fibroids.

Primary outcomes

  1. Prostate size (grams)

    Time frame: 1 year

    Reduction in size of the prostate to less than 80 grams

  2. Lower urinary symptoms (Arbitrary units)

    Time frame: 1 year

    Improvement of LUTS as defined by IPSS score <18.

Secondary outcomes

  1. Procedure completion without complication (percentage)

    Time frame: 1 year

    Completion of PAE without major complication

  2. Sexual Function (Arbitrary units)

    Time frame: 1 year

    Stability or improvement of sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire

  3. Quality of Life (Arbitrary units)

    Time frame: 1 year

    Improvement of quality of life as determined by an improved score on Quality of Life questionnaire

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2014
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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