[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-cystitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-cystitis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,39,67,92,102,145,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100054205","chronic-radiation-cystitis-and-effect-of-hyperbaric-oxygen-therapy-on-patient-reported-outcomes-and-urine-inflammatory-biomarkers-100054205",false,"NCT07368647","Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers","Inclusion Criteria:\n\nCohort 1\n\n* At least 18 years of age\n* Post pelvic radiation carrying the diagnosis of moderate to severe radiation cystitis and recurrent macroscopic hematuria in the absence of infection or urothelial malignancy. The diagnosis of moderate to severe (Radiation Therapy Oncology Group (RTOG) grade 2, 3-4) RC will be made by board-certified, reconstructive Urologists routinely managing radiation cystitis patients in their practices (RM \u002FWB,III) or co-investigator (JB) using Appendix B and confirmed with cystoscopy and negative urine cytology and\u002For bladder biopsy to rule out malignancy (which is standard of care of work up of hematuria as defined by the American Urology Association)45 once all other pathologies for gross hematuria have been excluded (including infection, malignancy, etc).\n* Scheduled to, or currently undergoing (initiated within the past 7 days), HBOT as part of standard of care therapy for radiation cystitis Cohort 2 HBOT controls\n* At least 18 years of age\n* Without a history of prior pelvic radiation\n* Scheduled to, or currently undergoing (initiated within the past 7 days) HBOT as part of standard of care therapy for reasons that do not include bladder inflammation) Cohort 3 Healthy controls\n* At least 18 years of age\n* Without history of pelvic radiation or HBOT Cohort 4\n* At least 18 years of age\n* Same as Cohort 1 except they OPT-OUT of participation in HBO therapy.\n\nExclusion Criteria:\n\nAll Cohorts\n\n* Pregnant or lactating (females will be asked if there is any chance they could be pregnant).\n* Uncompensated heart failure, uncompensated fluid overload, or uncompensated myocardial infarction preventing therapeutic HBOT\n* A history of: uncontrolled seizure disorder, active urinary tract infection, active Grave's disease, cystic fibrosis, sickle cell anemia, known HIV, or any autoimmune disease not in remission that requires active systemic steroid therapy or immune modulating medications.\n* Refusal to sign IRB approved informed consent document\n* Prior participation in a clinical trial that could potentially affect immunological status",true,"ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy",[24,25],"Radiation Cystitis","Urinary Tract Infection (Diagnosis)","RECRUITING","2026-07-09",{"date":29,"type":30},"2026-07-13","ACTUAL",{"date":32,"type":30},"2022-04-04",{"date":34,"type":20},"2027-12",{"name":36,"class":37},"Rachel A. Moses","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":45,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100644096","early-phase-1-clinical-efficacy-of-human-umbilical-cord-mesenchymal-stem-cell-derived-exosomes-combined-with-sodium-hyaluronate-intravesical-instillation-in-the-treatment-of-radiation-cystitis-100644096","NCT07665619","Clinical Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Combined With Sodium Hyaluronate Intravesical Instillation in the Treatment of Radiation Cystitis","Inclusion Criteria:\n\n* Female participants aged 18-80 years.\n* History of pelvic radiotherapy, with completion of radiotherapy at least 6 months prior to enrollment.\n* Clinically diagnosed with radiation cystitis accompanied by persistent lower urinary tract symptoms, such as urinary frequency, urgency, hematuria, or related symptoms.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute urinary tract infection or active tuberculous cystitis.\n* Bladder tumor or bladder metastasis from other malignant tumors.\n* Severe cardiac, pulmonary, hepatic, or renal dysfunction (e.g., ALT\u002FAST \\>3 times the upper limit of normal or serum creatinine above the upper limit of normal).\n* Pregnant or breastfeeding women.\n* Known allergy to sodium hyaluronate or stem cell-derived products.\n* Participation in another clinical trial within the past 3 months.","FEMALE","80 Years",{"count":48,"type":20},48,"INTERVENTIONAL",[51],"EARLY_PHASE1","The goal of this clinical trial is to learn whether intravesical instillation of human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate is safe and effective for treating radiation cystitis. Radiation cystitis is a complication that may occur after pelvic radiotherapy. Common symptoms include blood in the urine, frequent urination, urgent urination, and painful urination.\n\nThe main questions this study aims to answer are:\n\nCan human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate improve blood in the urine in participants with radiation cystitis? Can this combined treatment help repair injury to the bladder lining and blood vessels? What discomfort or medical problems may occur during the treatment?\n\nResearchers will compare four treatment approaches: human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate, human umbilical cord mesenchymal stem cell-derived exosomes alone, sodium hyaluronate alone, and normal saline as a control. By comparing these groups, researchers hope to find out whether the combined treatment works better than either treatment alone or the control treatment.\n\nParticipants will:\n\nBe screened to confirm whether they are eligible for the study; Sign an informed consent form and complete baseline assessments; Be randomly assigned to one of four treatment groups; Receive intravesical instillation once a week for 4 weeks; Attend follow-up visits at 1 month, 3 months, and 6 months after treatment; Be assessed for blood in the urine, urinary symptoms, cystoscopy findings, quality of life, and safety.\n\nThis study may help provide a new treatment option for radiation cystitis and further evaluate the safety and early effectiveness of this treatment.",[24],[24,55,56],"hUC-MSC-derived exosomes","Sodium hyaluronate","NOT_YET_RECRUITING","2026-06-18",{"date":60,"type":30},"2026-06-24",{"date":62,"type":20},"2026-06-01",{"date":64,"type":20},"2028-06-01",{"name":66,"class":37},"Fujian Medical University Union Hospital",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":38},"100416368","study-of-the-effects-of-anticoagulant-interruption-covered-by-percutaneous-left-atrial-occlusion-in-patients-with-chronic-atrial-fibrillation-and-radiation-cystitis-at-risk-of-bleeding-100416368","NCT04701749","Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding","HEMOCC","Inclusion Criteria:\n\n* Patient over 18 years old benefiting a social security sheme.\n* Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation.\n\nExclusion Criteria:\n\n* All the other hematuria's reasons\n* Other reason of anti platelet agent using than atrial fibrillation",{"count":75,"type":20},40,"The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).\n\nOne of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +\u002F- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.\n\nFurthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.\n\nIn recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.\n\nWhile studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.\n\nThe interest of this study will therefore be :\n\n* To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria.\n* To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.\n\nAs the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.\n\nThe mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.",[24,78],"Non-valvular Atrial Fibrillation",[80,81,82],"radiation cystitis","Hematuria","Left atrial appendage closure or left atrial occlusion (LAO)","2026-03-18",{"date":85,"type":30},"2026-03-19",{"date":87,"type":30},"2021-02-24",{"date":89,"type":20},"2030-09",{"name":91,"class":37},"University Hospital, Clermont-Ferrand",{"id":93,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":95,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":101,"locationsCount":38},"100621286",{"count":19,"type":20},[24,25],"2026-01-20",{"date":98,"type":30},"2026-01-26",{"date":32,"type":30},{"date":34,"type":20},{"name":36,"class":37},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":45,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":112,"studyType":21,"phases":4,"briefSummary":113,"conditions":114,"keywords":124,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.",{"count":111,"type":20},38,"4 Months","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[115,116,117,118,119,24,120,121,122,123],"Pelvic Toxicity","Radiation Toxicity","Chemotherapy Toxicity","Gynecological Tumors","Radiation Proctitis","Vaginal Mucositis","Vulvar Mucositis","Quality of Life","Dysbiosis",[125,126,127,128,129,130,131,132,133,134,123],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Radiotherapy","Chemotherapy","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","2025-12-16",{"date":137,"type":30},"2025-12-22",{"date":139,"type":20},"2026-01-15",{"date":141,"type":20},"2028-03-31",{"name":143,"class":37},"Bernardino Clavo, MD, PhD",2,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":15,"sex":16,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":49,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":38},"100602623","intravesical-hyaluronic-acid-ha-for-preventing-radiation-cystitis-on-bladder-cancer-100602623","NCT07125924","Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer","Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Pathologic confirmed Muscle-Invasive Urothelial Carcinoma I. Clinical stage: T2-T4a MIBC II. No or limited nodal involvement (N0 or partial N1, only isolated or regional) III. No distant metastasis (M0) IV. Transurethral resection of bladder tumor (TURBT): Maximal TURBT is available \\> Most tumors must be resected, and residual disease should be minimized.\n\n   V. Preserved bladder function is required: patients must have normal bladder capacity and maintain adequate voiding function.\n\n   VI. Unifocal or localized tumor (except multifocal) VII. No extensive carcinoma in situ (CIS)\n2. Age ≥ 19\n3. Karnofsky performance score (KPS) ≥ 70 or ECOG performance status 0\\~2\n4. Patients who are candidates for bladder-preserving therapy, specifically those scheduled to undergo concurrent chemoradiotherapy (CCRT) instead of radical cystectomy.\n5. Patients scheduled to receive radiotherapy in combination with one or more of the following chemotherapeutic agents prior to study enrollment: Cisplatin-based chemotherapy (e.g. weekly cisplatin), Gemcitabine or 5-FU\u002Fmitomycin, in accordance with standard clinical practice.\n6. Written informed consent obtained from the patients prior to study participation\n\nExclusion Criteria:\n\n1. Present of distant metastasis (M1)\n2. Tumor invasion beyond the bladder wall into adjacent organs (T4b)\n3. Non-urothelial carcinoma (including histologic variant) or predominant of non-urothelial components in mixed histology\n4. Medically inoperable status or poor general condition (ECOG performance status \\> 2)\n5. History of active cystitis or recurrent urinary tract infections within the past 6 months\n6. Known hypersensitivity to hyaluronic acid or related compounds\n7. Any condition in which, in the investigator's judgment, administration of the study drug or procedure is deemed inappropriate\n8. Pregnant or breastfeeding women, or women of childbearing potential who are unable or unwilling to use adequate contraception during the study period","19 Years",{"count":154,"type":20},54,[156],"NA","To evaluate the efficacy and safety of intravesical hyaluronic acid (HA) instillation therapy for the prevention of radiation-induced cystitis in patients undergoing radiotherapy for bladder cancer.",[159,24],"Bladder Cancer",[161,24,162,163],"Hyaluronic acid","Intravesical treatment","Prevention","2025-08-09",{"date":166,"type":30},"2025-08-15",{"date":168,"type":20},"2025-08-22",{"date":170,"type":20},"2027-12-31",{"name":172,"class":173},"National Cancer Center, Korea","OTHER_GOV",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":181,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":49,"phases":184,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":38},"100458128","phase-2-radiation-cystitis-treated-with-pentosan-polysulfate-sodium-trial-100458128","NCT05245591","Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial","A Randomized, Controlled, Phase II\u002FIII Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis","Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.\n2. Patients must be ≥20 years of age\n3. Patients must have received definitive radiation therapy for cancer in pelvic area.\n4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.\n5. Radiation cystitis with lower urinary tract symptoms or hematuria.\n\nExclusion Criteria:\n\n1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal\n2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal\n3. Abnormal coagulation profile with PT\u002FINR higher than normal\n4. Thrombocytopenia with platelet counts \\\u003C 100,000\u002FμL\n5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test\n6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts \\>12,000\u002FμL)\n7. Patients with known urinary tract infection within 6 months of randomization.\n8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)\n9. Any previous hyperbaric oxygen therapy within 6 months of randomization\n10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization\n11. Has history of thrombocytopenia, hemophilia or bladder cancer\n12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation\n13. Has known history of drug allergy to pentosan polysulfate sodium\n14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma","20 Years",{"count":183,"type":20},72,[185,186],"PHASE2","PHASE3","The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.",[24],"2022-05-02",{"date":191,"type":30},"2022-05-04",{"date":193,"type":30},"2022-04-29",{"date":195,"type":20},"2029-11-01",{"name":197,"class":37},"National Taiwan University Hospital"]