RecruitingPhase 2Phase 3NCT06096597

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial


Sponsor

David Sheyn

Enrollment

100 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Clarix Flo and a drug called Placebo for people with interstitial cystitis, painful bladder syndrome, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClarix 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

DRUGPlacebo

10 mL of 0.9% preservative-free sodium chloride


Locations(1)

University Hospitals

Clevleand, Ohio, United States

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NCT06096597


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