[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cystitis-interstitial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cystitis-interstitial":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100641455","phase-1-safety-and-preliminary-efficacy-of-endoscopic-submucosal-injection-of-hyaluronic-acid-into-the-bladder-wall-in-patients-with-interstitial-cystitisbladder-pain-syndrome-icbps-100641455",false,"NCT07658118","Safety and Preliminary Efficacy of Endoscopic Submucosal Injection of Hyaluronic Acid Into the Bladder Wall in Patients With Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","A Pilot Open-Label Prospective Study of Safety and Preliminary Efficacy of Endoscopic Submucosal Injection of Hyaluronic Acid Into the Bladder Wall in Patients With Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","HA-IC\u002FBPSPilot","Inclusion Criteria:\n\n* Men and women aged ≥ 18 years.\n* Confirmed diagnosis of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS) based on cystoscopic findings (glomerulations after hydrodistension or Hunner's lesions).\n* Refractory to at least 2 lines of standard therapy (e.g., dietary modifications, oral medications, intravesical hyaluronic acid instillations, hydrodistension) for ≥ 6 months.\n* Pain score ≥ 4 on a 0-10 Visual Analog Scale (VAS) at screening.\n* Ability and willingness to provide written informed consent and to complete a 3-day voiding diary.\n\nExclusion Criteria:\n\n* Active urinary tract infection (bacteriuria \\> 10⁴ CFU\u002FmL).\n* History of genital herpes.\n* Severe renal failure (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n* Known allergy to hyaluronic acid or any component of the study product.\n* Pregnancy or breastfeeding.\n* Psychiatric disorders or substance abuse that would interfere with study participation.\n* Participation in another clinical study within 30 days prior to enrollment.","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this pilot clinical trial is to learn if injecting hyaluronic acid into the bladder wall is safe and if it works to reduce pain and urinary frequency in people with interstitial cystitis (IC), also called bladder pain syndrome (BPS).\n\nWho can take part? Adults aged 18 and older who have IC\u002FBPS that did not get better after at least two standard treatments (such as diet changes, oral drugs, or bladder instillations) for 6 months or more.\n\nMain questions the study aims to answer:\n\nWhat side effects (medical problems) do participants have after the injection procedure?\n\nDoes the injection lower pain and reduce how often a person needs to urinate, compared to before the treatment?\n\nWhat will happen in the study? There is no comparison group or placebo (a look-alike substance with no drug). All participants receive the same treatment.\n\nParticipants will:\n\nHave a one-time procedure under intravenous anesthesia (medicine that puts them to sleep)\n\nReceive 20 small injections of hyaluronic acid into the bladder wall using a thin tube with a camera (cystoscope)\n\nHave small tissue samples taken from the bladder (biopsy) during the same procedure\n\nKeep a 3-day diary of their urination\n\nFill out short questionnaires about pain, symptoms, and quality of life\n\nReturn for follow-up visits at 1 day, 1 week, 4 weeks, 3 and 6 months after the injection.\n\nAt the 4-week visit, participants will have cystoscopy with bladder biopsy and may receive a second injection if the first one helped.\n\nPossible benefits We cannot guarantee that this experimental treatment will help everyone. However, based on years of experience with similar hyaluronic acid injections in other body parts, researchers hope that injecting the substance directly into the bladder wall will give longer-lasting relief than standard bladder instillations.\n\nRisks and side effects\n\nThe most common expected side effects are:\n\nBlood in the urine for a few hours or days (usually goes away on its own) Temporary increase in pain or burning when urinating Infection (unlikely; the team will give antibiotics to lower the risk) Serious problems such as bladder wall puncture or allergic reaction are very rare.\n\nParticipation is voluntary People can join or leave the study at any time without giving a reason. Refusing or stopping will not affect their regular medical care at the hospital.\n\nConfidentiality All personal information will be kept private. Results will only be shared in combined, anonymous form (no names or identifying details).",[27,28],"Cystitis, Interstitial","Chronic Pain",[30,31,32],"Bladder Pain Syndrome","IC\u002FBPS","Hyaluronic Acid Injection","NOT_YET_RECRUITING","2026-06-20",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2027-01",{"name":43,"class":44},"Sverdlovsk Regional Clinical Hospital No.1","NETWORK",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":67,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100539118","pain-type-and-interstitial-cystitisbladder-pain-syndrome-treatment-100539118","NCT06299683","Pain Type and Interstitial Cystitis\u002FBladder Pain Syndrome Treatment","Mechanistic-Based Treatment of Interstitial Cystitis\u002FBladder Pain Syndrome","Inclusion Criteria:\n\n* 18 years of age or older;\n* Diagnosis of IC\u002FBPS as indicated by structured assessments;\n* Capable of giving written informed consent;\n* Able to enroll for the duration of the study period;\n\nExclusion Criteria:\n\n* Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke;\n* Current or history of diagnosis of primary psychotic or major thought disorder within the past five years;\n* Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and\u002For PTSD (within the past 5 years);\n* Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months;\n* Non-English speaking;\n* Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking;\n* Difficulties or limitations communicating over the telephone or via teleconferencing systems;\n* Any planned life events that would interfere with participating in the key elements of the study;\n* Any major active medical issues that could preclude participation;\n* Currently pregnant;\n* Currently being treated for cancer;\n* Cancer-related pain;\n* Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt).",{"count":53,"type":21},220,[55],"NA","Interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC\u002FBPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC\u002FBPS have distinct subgroups, or \"phenotypes,\" largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC\u002FBPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC\u002FBPS.",[58,30,59,27,60,61,62,63,64,65,66],"Chronic Interstitial Cystitis","Painful Bladder Syndrome","Cystitis, Chronic Interstitial","Interstitial Cystitis","Interstitial Cystitis, Chronic","Interstitial Cystitis (Chronic) With Hematuria","Interstitial Cystitis (Chronic) Without Hematuria","Chronic Prostatitis","Chronic Prostatitis With Chronic Pelvic Pain Syndrome",[68,69,70,71,72,73,74,75,76,77,78],"interstitial cystitis","bladder pain syndrome","clinical trial","psychosocial intervention","pelvic pain","therapy","urological chronic pelvic pain syndrome","chronic prostatitis","self-management","cognitive behavioral therapy","pelvic floor physical therapy","RECRUITING","2026-01-20",{"date":82,"type":37},"2026-01-21",{"date":84,"type":37},"2024-05-01",{"date":86,"type":21},"2028-04-04",{"name":88,"class":89},"Vanderbilt University Medical Center","OTHER",1]