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RecruitingAccepts healthy volunteersPhase 2/Phase 3

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

David Sheyn · NCT06096597

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
100
US sites recruiting
1
Study start
July 24, 2024
Record last updated
September 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Clarix Flo; Placebo

Conditions: Interstitial Cystitis; Painful Bladder Syndrome; Painful Bladder Syndrome (PBS)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University Hospitals

    Clevleand, OH 44106

    Site contact: Diana Mitchell, MD · (216) 844-3009 · diana.mitchell@uhhospital.org

Study contacts (from the official record)

  • Diana Mitchell, MD · (216) 844-3009 · diana.mitchell@uhhospitals.org
  • David Sheyn, MD · David.Sheyn@uhhospitals.org
All healthy volunteers studies in Ohio →
Amniotic Membrane Therapy for Interstitial Cystitis/Painful… (NCT06096597) | Bored Studies