Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

This study is testing a treatment called Clarix Flo, which uses micronized amniotic membrane, for people with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). IC/PBS causes bladder and pelvic pain, pressure, and frequent or urgent urination. Researchers want to see if Clarix Flo can improve these symptoms. You might be able to join if you are a woman, 18 or older, speak English, have been diagnosed with IC/PBS, and have already tried at least one other treatment that didn't work. The study will measure success by looking at changes in your symptom scores over 12 weeks. The current status of this study is unclear, but it plans to enroll 100 participants.

Study design
This study is an interventional trial, meaning participants will receive a specific treatment. It plans to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after treatment.

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NCT06096597

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Recruiting
PHASE2Ages 18+InterventionalTreatment
David Sheyn
~100 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Clarix FloPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Interstitial Cystitis Symptom Index (ICSI) score
Measured over To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Interstitial Cystitis
Painful Bladder Syndrome
Painful Bladder Syndrome (PBS)
1 sites across 1 states
Ohio1
  • David Sheyn, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

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Eligibility criteria

Inclusion

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

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
  • Change in Interstitial Cystitis Symptom Index (ICSI) scoreTo be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

    Evaluate for clinically-meaningful reduction in symptoms as defined as a 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)