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Prostatic Retraction Device
Butterfly Device for Lower Urinary Tract Symptoms
N/A
Recruiting
Research Sponsored by Butterfly Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate volume 30-90 ml
Male patient age 50 to 80
Must not have
Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis)
Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Summary
This trial is studying if a device called the Butterfly is better than a sham procedure at treating urinary symptoms in men.
Who is the study for?
Men aged 50-80 with benign prostatic hyperplasia (BPH), experiencing moderate to severe urinary symptoms, and a prostate size of 30-90 ml. Candidates must not have had prior prostate surgery or suffer from conditions like uncontrolled diabetes, neurological disorders, or active bladder issues. They should not be on certain medications for BPH or have a history of prostate cancer.
What is being tested?
The Butterfly Pivotal Study is testing the effectiveness of the Butterfly Prostatic Retraction Device in improving urinary symptoms in men with BPH. Participants are randomly assigned to either receive this device treatment or undergo a sham procedure without actual treatment.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort during the procedure, possible infection risk due to instrumentation, and individual reactions to the device material if there's an allergy to nickel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate size is between 30 to 90 ml.
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I am a man aged between 50 and 80.
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I have symptoms of an enlarged prostate with a score of 13 or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had kidney stones grow, pass, or bladder stones in the last 3 months.
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I have had or currently have a narrowing in my urinary passage.
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My bladder and prostate shape allow for safe surgical equipment use.
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I currently have a serious urinary tract infection.
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I have issues emptying my bladder that may be due to nerve problems.
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I am currently unable to empty my bladder completely.
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My prostate has a significant growth into my bladder.
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My bladder test results show low flow, incomplete emptying, or small void volume.
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I have a urethral condition like a blockage, growth, or abnormal connection.
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I currently have an active bladder tumor.
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I have a bleeding disorder that is not under control.
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I frequently urinate more than usual, especially at night.
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I experience urine leakage when I cough or sneeze.
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I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.
Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cross overExperimental Treatment1 Intervention
Sham arm patient is allowed to crossover and undergo the Butterfly procedure
Group II: ActiveActive Control1 Intervention
The active arm patients undergo the Butterfly device procedure.
Group III: Sham ComparatorPlacebo Group1 Intervention
The sham control arm patients undergo a rigid cystoscopy procedure.
Find a Location
Who is running the clinical trial?
Butterfly Medical Ltd.Lead Sponsor
2 Previous Clinical Trials
152 Total Patients Enrolled
Adrian Paz, MDStudy DirectorMedical director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had kidney stones grow, pass, or bladder stones in the last 3 months.My prostate length is between 25mm and 45mm.I think I have an overactive bladder.I have had or currently have a narrowing in my urinary passage.My bladder and prostate shape allow for safe surgical equipment use.I currently have a serious urinary tract infection.I have issues emptying my bladder that may be due to nerve problems.I've had prostate surgery or a procedure, but not significant fibrosis.I am currently unable to empty my bladder completely.My PSA is over 10 ng/mL, or I might have prostate cancer.My prostate has a significant growth into my bladder.My prostate length is between 25mm and 45mm.I have taken phenylephrine or pseudoephedrine within the last 24 hours.My bladder test results show low flow, incomplete emptying, or small void volume.I have been taking specific medications for bladder or prostate issues, or hormone treatments.I do not have any conditions that would prevent me from completing the study or affect its results.I have a condition like diabetes or Parkinson's that affects my bladder control.I have a urethral condition like a blockage, growth, or abnormal connection.My prostate size is between 30 to 90 ml.I currently have an active bladder tumor.You have a condition where the opening of your bladder is blocked, and it is difficult for you to urinate.I have a bleeding disorder that is not under control.I frequently urinate more than usual, especially at night.I have not taken 5 alpha reductase inhibitors in the last 6 months.I am a man aged between 50 and 80.You are allergic to nickel.I have symptoms of an enlarged prostate with a score of 13 or more.I had a prostate biopsy in the last 6 weeks.I experience urine leakage when I cough or sneeze.I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Sham Comparator
- Group 3: Cross over
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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