[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sverdlovsk Regional Clinical Hospital No.1\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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",""]