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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03052049
Other study ID # STU 00204385
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2017
Est. completion date September 26, 2022

Study information

Verified date October 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).


Description:

This pilot study will be a single center, open labeled, non-randomized feasibility study to evaluate the initial safety of PAE for the treatment of symptomatic bladder outlet obstruction. 30 adult male subjects will be enrolled in this study. If eligible patients will undergo the prostate artery embolization procedure in the Interventional Radiology department. An angiogram of the prostate arteries will be done. Small beads called Bead Block microspheres will be injected into the prostate artery to slow blood flow to the prostate in the hope of providing relief with minimal side effects and complications, for lower urinary tract symptoms caused by BPH. After the procedure the patient will be followed at 4 weeks, 12 weeks, 6 months, and 12 months post procedure.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Prostate Artery Embolization
The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.

Locations

Country Name City State
United States Northwestern Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure:
Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death.
1 year
Secondary Change in International Prostate Symptom Score (IPSS) Questionnaire- IPSS has 7 questions. Answer choices are as follows. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.
It is a validated, reproducible scoring system to assess disease severity and response to therapy.
The IPSS is made up of 7 questions related to voiding symptoms. Scores can range from 0-35 with 0 being the better outcome and 35 the worst outcome.
Question 1-6 0-Not at all
Less than 1 time in 5
Less than half the time
About half the time
More than half the time
Almost always
Question 7 0-None 1-1 time 2-2 times 3-3 times 4-4 times 5-5 or more times
Baseline, 1, 3, 6, 12 months post procedure
Secondary Change in Quality of Life (QOL) Bother Score The total score ranges from 0-6 with 0 being the best outcome and 6 being the worst outcome.
Questionnaire- answers choices are as follows:
0- Delighted
Pleased
Mostly Satisfied
Mixed about equality satisfied and dissatisfied
Mostly Dissatisfied
Unhappy
Terrible
Baseline, 1, 3, 6, 12 months post procedure
Secondary Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score The BPH Impact Index is to assess the impact of BPH symptoms on patient health and functioning. It is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.The BII is an evaluative index useful in measuring the magnitude of change in the impact of BPH-LUTS within a person over time.
Scores range from 0-13 with 0 being the best outcome and 13 being the worst.
Questionnaire- consists of 4 questions; answer choices are as follows Question 1: 0-none, 1-only a little, 2-some, 3-a lot Question 2: 0-none, 1-only a little, 2-some, 3-a lot Question 3: 0-not at all bothersome, 1- bothers me a little, 2-bothers me some, 3-bothers me a lot Question 4: 0-none of the time, 1- a little of the time, 2- some of the time, 3-most of the time, 4-all of the time
Baseline, 1, 3, 6, 12 months post procedure
Secondary Change in Peak Urine Flow (Qmax) Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements Baseline, 1, 3, 6, and 12 months post procedure
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