Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• Patients 18 years of age or older
• Female
• English Speaking
• Diagnosis of IC/PBS
• Have failed at least one prior treatment for IC/PBS
Locations
United States
Ohio
University Hospitals
RECRUITING
Clevleand
Contact Information
Primary
Margot Le Neveu, MD
Margot.LeNeveu@uhhospitals.org
(440) 895-7685
Backup
David Sheyn, MD
David.Sheyn@uhhospitals.org
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2026-06
Participants
Target number of participants: 100
Treatments
Experimental: Amniotic Membrane Therapy
Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 100mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride, and 0.5 mL of the solution will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.
Placebo_comparator: Placebo
Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 0.5 mL of 10 mL of 0.9% preservative-free sodium chloride will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.
Related Therapeutic Areas
Sponsors
Leads: David Sheyn