Using amniotic membrane therapy to treat interstitial cystitis and painful bladder syndrome
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
PHASE2; PHASE3 · University Hospitals Cleveland Medical Center · NCT06096597
This study is testing whether injections of amniotic membrane therapy can help people with interstitial cystitis and painful bladder syndrome feel less pain and improve their urinary symptoms.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 1 site (Clevleand, Ohio) |
| Trial ID | NCT06096597 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking females aged 18 and older who have been diagnosed with IC/PBS and have not responded to at least one prior treatment.
Not a fit: Patients under 18 years of age, non-English speakers, or those with anatomical malformations of the urinary tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide significant relief from bladder pain and urinary symptoms for patients with IC/PBS.
How similar studies have performed: While preliminary studies have shown promising results with amniotic membrane therapy for bladder conditions, this is the first randomized controlled trial assessing its efficacy for IC/PBS.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clevleand, Ohio
- University Hospitals — Clevleand, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Margot Le Neveu, MD
- Email: Margot.LeNeveu@uhhospitals.org
- Phone: (440) 895-7685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Interstitial Cystitis, Painful Bladder Syndrome, interstitial cystitis, painful bladder syndrome