Active for Lower Urinary Tract Symptoms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Manhattan Medical Research, New York, NY
Lower Urinary Tract Symptoms+4 More
Butterfly Prostatic Retraction Device - Device
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is studying if a device called the Butterfly is better than a sham procedure at treating urinary symptoms in men. Active is a medication used to treat Lower Urinary Tract Symptoms.

Eligible Conditions

  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 12 month

12 month
Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months
3 month
Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.

Trial Safety

Trial Design

2 Treatment Groups

Active
1 of 2
Sham Comparator
1 of 2
Active Control
Non-Treatment Group

222 Total Participants · 2 Treatment Groups

Primary Treatment: Active · Has Placebo Group · N/A

Sham Comparator
Device
ShamComparator Group · 1 Intervention: Butterfly Prostatic Retraction Device · Intervention Types: Device
Active
Device
ActiveComparator Group · 1 Intervention: Butterfly Prostatic Retraction Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month
Closest Location: Manhattan Medical Research · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2013First Recorded Clinical Trial
2 TrialsResearching Lower Urinary Tract Symptoms
26 CompletedClinical Trials

Who is running the clinical trial?

Butterfly Medical Ltd.Lead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
Adrian Paz, MDStudy DirectorMedical director

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.