RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Sponsor: David Sheyn • ClinicalTrials.gov ID: NCT06096597

Registry updated: 2026-09-04

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Description

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.

Interventions

Clarix Flo (Drug)
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 (Drug)
10 mL of 0.9% preservative-free sodium chloride

Eligibility criteria

Inclusion Criteria: * Patients 18 years of age or older * Female * English Speaking * Diagnosis of IC/PBS * Have failed at least one prior treatment for IC/PBS Exclusion Criteria: * Patients less than 18 years of age * Unable to provide consent * Non-English speaking * Patients with known anatomical malformations of the ureters, bladder, or urethra

Conditions

Interstitial Cystitis Painful Bladder Syndrome Painful Bladder Syndrome (PBS)

Locations

University Hospitals — Clevleand, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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