Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)
Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy
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.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC Hospitals
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Prostatic artery embolization
Microspheres measuring 100-300 microns will be injected under fluoroscopic guidance into the left and right prostatic arteries for embolization.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prostate size (grams)
기간: 1 year
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Reduction in size of the prostate to less than 80 grams
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1 year
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Lower urinary symptoms (Arbitrary units)
기간: 1 year
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Improvement of LUTS as defined by IPSS score <18.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Procedure completion without complication (percentage)
기간: 1 year
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Completion of PAE without major complication
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1 year
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Sexual Function (Arbitrary units)
기간: 1 year
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Stability or improvement of sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire
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1 year
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Quality of Life (Arbitrary units)
기간: 1 year
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Improvement of quality of life as determined by an improved score on Quality of Life questionnaire
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ari Isaacson, MD, University of North Carolina, Chapel Hill
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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