Actively Recruiting
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome: A Prospective, Double-Blind, Randomized Controlled Trial
Led by David Sheyn · Updated on 2026-06-05
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating amniotic membrane therapy for women with interstitial cystitis/painful bladder syndrome (IC/PBS), a condition marked by bladder or pelvic pain along with urinary frequency and urgency. This study aims to determine if this therapy can improve symptoms significantly, using validated questionnaires. IC/PBS symptoms vary in severity and affect quality of life, and current treatments include behavior changes, medications, injections, and sometimes surgery. Amniotic membranes have been used in wound healing and show promise for bladder treatment, but no randomized controlled trials have been done yet. The study involves two groups randomized to receive either amniotic membrane therapy or a placebo. Both groups undergo cystoscopy under general anesthesia, where injections are made into the bladder muscle at multiple sites. The amniotic membrane group receives 100 mg of micronized Clarix FLO diluted in saline, while the placebo group receives saline alone. The injections are carefully placed to avoid certain bladder areas. This trial is double-blind, meaning neither the participants nor the researchers know who receives which treatment during the study. Participants will be followed for 12 weeks after treatment with clinical evaluations and symptom questionnaires at 2, 4, 8, and 12 weeks. Additional urine cultures and bladder residual volume tests will be done at 2 and 4 weeks. Researchers will measure changes in symptom scores, including the Interstitial Cystitis Symptom Index and other related scales, to assess the therapy's effects. They will also monitor for side effects like urinary tract infections or urinary retention. The total participation duration is about three months post-treatment.
CONDITIONS
Brief Title
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Female
- English speaking
- Diagnosis of interstitial cystitis/painful bladder syndrome (IC/PBS)
- Have failed at least one prior treatment for IC/PBS
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive intradetrusor injections of either micronized amniotic membrane (Clarix Flo) or placebo under general anesthesia.
1 treatment visit (in-person)
Duration - 12 weeks
Participants are followed with clinical evaluations, questionnaires, urine cultures, and post void residual measurements to assess treatment effects and safety.
Visits at 2, 4, 8, and 12 weeks post-treatment, including additional urine culture and post void residual assessments at 2 and 4 weeks
Trial Site Locations
Total: 1 location
1
University Hospitals
Clevleand, Ohio, United States, 44106
Actively Recruiting
Research Team
D
Diana Mitchell, MD
D
David Sheyn, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here