The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
215
Flexible cystoscopy to deploy medical device used to treat BPH
Flexible Cystoscopy without deployment of medical device used to treat BPH
Michael G Oefelein Clinical Trials
Bakersfield, California, United States
Change in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL). The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic
Time frame: 12 months
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Time frame: 3 months
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Time frame: 6 months
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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