About this trial

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

Qualifiers

Patients 18 years of age or older

Female

English Speaking

Diagnosis of IC/PBS

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Clarix Flo
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1
University Hospitals44106, ClevleandOhio, United States

Sponsors and collaborators

David Sheyn

Lead sponsor

University Hospitals Cleveland Medical Center

Sponsor institution