[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523508":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":53,"collaborators":26,"id":57,"slug":26,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University Hospitals Cleveland Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amniotic Membrane Therapy","EXPERIMENTAL","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.",[13],"Drug: Clarix Flo",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","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.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Clarix Flo","100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"10 mL of 0.9% preservative-free sodium chloride",[15],[31],{"name":32,"affiliation":5,"role":33},"David Sheyn, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Diana Mitchell, MD","CONTACT","(216) 844-3009","diana.mitchell@uhhospitals.org",{"name":32,"role":37,"phone":26,"phoneExt":26,"email":41},"David.Sheyn@uhhospitals.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":26,"geoPoint":26,"contacts":50},"University Hospitals","RECRUITING","Clevleand","Ohio","44106","United States",[51],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":52},"diana.mitchell@uhhospital.org",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","David Sheyn","Physician, UH Hospitals","100523508",false,"NCT06096597","Amniotic Membrane Therapy for Interstitial Cystitis\u002FPainful Bladder Syndrome","Amniotic Membrane Therapy for Interstitial Cystitis\u002FPainful Bladder Syndrome (IC\u002FPBS): a Prospective, Double-Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Female\n* English Speaking\n* Diagnosis of IC\u002FPBS\n* Have failed at least one prior treatment for IC\u002FPBS\n\nExclusion Criteria:\n\n* Patients less than 18 years of age\n* Unable to provide consent\n* Non-English speaking\n* Patients with known anatomical malformations of the ureters, bladder, or urethra",true,"FEMALE","18 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE2","PHASE3","Interstitial cystitis\u002Fpainful bladder syndrome (IC\u002FPBS) is a clinical syndrome in which patients report symptoms of bladder and\u002For pelvic pain with pressure and\u002F or discomfort associated with urinary frequency and urgency.\n\nThe primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis\u002Fpainful bladder syndrome (IC\u002FPBS) as defined by clinically-significant improvement in validated symptom questionnaires.",[75,76,77],"Interstitial Cystitis","Painful Bladder Syndrome","Painful Bladder Syndrome (PBS)",[79,80],"interstitial cystitis","painful bladder syndrome","2026-06-03",{"date":83,"type":84},"2026-06-05","ACTUAL",{"date":86,"type":84},"2024-07-24",{"date":88,"type":68},"2026-06",{"name":55,"class":6},1]