Using amniotic membrane therapy to treat interstitial cystitis and painful bladder syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of amniotic membrane therapy in patients suffering from interstitial cystitis/painful bladder syndrome (IC/PBS). The study will involve administering intradetrusor injections of Clarix FLO™, a micronized amniotic membrane, to assess improvements in bladder pain and urinary symptoms. Participants will be monitored for clinically significant changes using validated symptom questionnaires. This trial represents the first randomized controlled trial of this innovative treatment approach for IC/PBS.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals
  Clevleand, Ohio, United States Recruiting

Study contacts

• Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
• Study coordinator: Diana Mitchell, MD
• Email: diana.mitchell@uhhospitals.org
• Phone: (216) 844-3009

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.