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
David Sheyn
100 participants
Jul 24, 2024
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
Inclusion Criteria5
- 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 Criteria4
- 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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Interventions
100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride
10 mL of 0.9% preservative-free sodium chloride
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06096597