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Recruiting Phase 2, Phase 3 NCT06096597

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Trial Parameters

Condition Interstitial Cystitis
Sponsor David Sheyn
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-07-24
Completion 2026-06
Interventions
Clarix FloPlacebo

Brief 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 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

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