Prostate Embolization for Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT01924988|
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : November 27, 2019
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: Prostatic Embolization with Embosphere Micropsheres||Phase 1 Phase 2|
Objectives of the investigation
This study has a primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary outcome is the frequency of adverse events, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will allow us to begin to determine its effectiveness in diminishing obstructive symptoms associated with BPH.
Duration of investigation
The investigation will enroll 30 patients, with a target enrollment period of less than 12 months. Each patient will be consented for follow-up up to 5 years, but each patient will reach the first important safety endpoint 1 week after treatment and the first clinical efficacy assessment 3 months after treatment.
To determine the safety and effectiveness of prostate artery embolization for the treatment of BPH.
Description of study type
This is a prospective non-comparative treatment study of an initial cohort of 30 patients.
The patients will be recruited from the urology practice at Georgetown University and from other urologists in the area and by patient self-referral. The study also will be announced on a study website, the content of which will be approved by the IRB at Georgetown University Medical Center.
The primary outcome is the absence of complications to the bladder, rectum or other pelvic structures detected in the first week after therapy. Each patient will be judged free of these adverse events or not. For those with an adverse event, the complication will be scored using the Society of Interventional Radiology (SIR) definitions. Descriptive statistics will be used to summarize these events, along with patient demographics and initial clinical status.
Appropriate parametric and non-parametric tests will be used to assess change in laboratory measures, urine flowmetry parameters, and scores from the IPSS and IIEF. Changes in prostate volumes and the estimated volume of devascularized tissue will be calculated for each patient and outcomes from the different embolics will be compared. Appropriate paired parametric and non-parametric tests will be used to determine statistical significance. A p value of 0.05 will be considered statistically significant.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostate Embolization for Benign Prostatic Hyperplasia|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Prostatic Embolization
Therapeutic occlusion of the prostate arteries
Device: Prostatic Embolization with Embosphere Micropsheres
Each patient will have a selective internal iliac arteriogram, and as necessary, an arteriogram of the anterior division of the internal iliac artery performed to identify the prostatic arterial supply. This typically arises from the inferior vesicle artery (also known as the prostatic artery), but may have supply from the superior vesicle, the internal pudendal or obturator branches as well.
The prostatic arteries will be selected using standard micro-catheter technique. Embolization of the prostate will be performed with 300 to 500 um sized TAGM (Embosphere® Microspheres, Merit Medical, South Jordan, UT). The embolization endpoint will be absence of the normal blush of the prostate on post embolization angiography and stasis of flow in the prostate arteries.
- Number of Participants With Bladder or Rectal Injury [ Time Frame: Evaluated 1 week after procedure ]Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.
- Detection of Bladder Injury [ Time Frame: 3 months after treatment ]Bladder injury as detected by cystoscopy
- Detection of a Bladder Injury [ Time Frame: 6 months after treatment ]Bladder injury detected by cystoscopy
- Detection of a Bladder Injury by Cystoscopy [ Time Frame: 12 months after the procedure ]Number of patients with a bladder injury detected by cystoscopic examination
- International Prostate Symptom Score (IPSS) [ Time Frame: 1week, 3 months, 6months, 12months ]Measure Description: Validated patient reported questionnaire to assess the severity of lower urinary tract symptoms associated with benign prostatic enlargement. Severity of symptom scores range from 0 to 35, with a score of 0-7 considered mild, 8-19 moderate and 20 to 35 severe symptoms.
- International Index of Erectile Function (IIEF)- 5 [ Time Frame: 1week, 3 months, 6months, 12months ]Measure Description: IIEF-5 is a 5 question validated patient reported outcome measure or erectile dysfunction (ED), with a range of scores from 5 to 25, and ED was classified into five categories or erectile function based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
- QMax (Peak Urinary Flow) [ Time Frame: 1week, 3 months, 6months, 12months ]Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924988
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|