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Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Sponsor: David Sheyn
Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency. The primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement in validated symptom questionnaires.
Official title: Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-07-24
Completion Date
2026-06
Last Updated
2025-08-17
Healthy Volunteers
Yes
Interventions
Clarix Flo
100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride
Placebo
10 mL of 0.9% preservative-free sodium chloride
Locations (1)
University Hospitals
Clevleand, Ohio, United States