Health Trials

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

ConditionsInterstitial CystitisPainful Bladder SyndromePainful Bladder Syndrome (PBS)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDavid Sheyn

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

Map coordinates are unavailable for these locations. Locations are shown below instead.

University HospitalsRecruiting44106, Clevleand, OhioUnited StatesUnited States

Sponsors and collaborators

David Sheyn

Lead sponsor

University Hospitals Cleveland Medical Center

Sponsor institution

Source ClinicalTrials.gov