[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-pain-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-pain-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,78,100,124,150,179,207,226,263,287,310,338,361,388,427,447,472],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100053256","phase-1-venlafaxine-combined-with-education-and-behavioral-intervention-for-bladder-pain-syndrome-100053256",false,"NCT07698626","Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome","A Multicenter, Open-label, Observer-blinded Randomized Controlled Trial Comparing the Efficacy and Safety of Venlafaxine Plus Education and Behavioral Modification Program Versus Education and Behavioral Modification Program Alone in Adults With Interstitial Cystitis\u002FBladder Pain Syndrome","VEN-BPS","Inclusion Criteria:\n\nAge ≥ 18 years (all genders) Confirmed IC\u002FBPS diagnosis fulfilling AUA 2015 and ESSIC standardized diagnostic criteria, ruled out confounding urologic disorders Predominant lower urinary tract symptoms present for most days in the past 3 months Baseline bladder\u002Fpelvic pain and urinary frequency score ≥ 3 points on 0-10 Likert scale within prior 4 weeks\n\nExclusion Criteria:\n\nSymptomatic urethral stricture Active degenerative\u002Finflammatory neurological disease altering bladder\u002Fintestinal function Uncontrolled active autoimmune disease or systemic infection Medical history of pelvic tuberculosis, pelvic radiotherapy or chemotherapy-induced cystitis History of non-cutaneous malignant tumors Current diagnosis of severe psychiatric disorders (major depressive disorder, bipolar disorder, schizophrenia, psychotic disorders) Clinically significant moderate-severe cardiac, pulmonary, hepatic or renal insufficiency Documented hypersensitivity to venlafaxine or other SNRI drugs Concurrent regular use of antibiotics or NSAIDs throughout trial period Pregnancy or breastfeeding state at screening","ALL","18 Years","80 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study aims to compare two treatment plans for adults with bladder pain syndrome (also called interstitial cystitis), a disease that causes long-lasting bladder pain, frequent urination and urgent need to pee. All participants will receive standardized patient education and behavioral training to relieve urinary discomfort. Half of the participants will only get this behavioral intervention, while the other half will take oral venlafaxine in addition to the same behavioral training for 12 weeks. We will check patients' pain levels, urination frequency, sleep quality, mood and daily life ability at 1, 2, 6 and 12 weeks of treatment. The main goal is to see whether adding venlafaxine can better ease bladder pain and urinary symptoms without obvious side effects. This research will provide safer and more effective treatment suggestions for patients with bladder pain syndrome.",[28,29,30],"Bladder Pain Syndrome","Chronic Pelvic Nociplastic Pain","Interstitial Cystitis","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":22},"2026-12-31",{"date":39,"type":22},"2027-12-31",{"name":41,"class":42},"Beijing Tiantan Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100450751","investigation-of-pemf-therapy-for-female-patients-with-icbps-100450751","NCT05149573","Investigation of PEMF Therapy for Female Patients With IC\u002FBPS","Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","Inclusion Criteria:\n\n* Previously established clinical diagnosis of IC\u002FPS\n* Current numeric rating scale (NRS) score of ≥ 6\n* History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia\n* No cognitive deficits\n\nExclusion Criteria:\n\n* History of bladder, ovarian, vaginal cancer\n* History of urethral diverticulum\n* History of radiation cystitis\n* History of spinal cord injury or spina bifida\n* History of Parkinson's disease, multiple sclerosis, or stroke\n* Current placement of a pacemaker or metal prosthesis\n* Active urinary tract infection\n* BMI \\> 40\n* Residual urine of \\> 100cc\n* Current pregnant","FEMALE",{"count":52,"type":22},75,[54],"NA","The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC\u002FBPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline\u002Fenrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.",[30,57,28],"Chronic Interstitial Cystitis",[59,60,61,62,63,64,65,66],"interstitial cystitis","bladder pain syndrome","painful bladder syndrome","painful bladder","bladder pain","urinary urgency","urinary frequency","pulsed electromagnetic field","RECRUITING","2026-05-06",{"date":70,"type":35},"2026-05-07",{"date":72,"type":35},"2022-08-29",{"date":74,"type":22},"2027-02",{"name":76,"class":42},"Wake Forest University Health Sciences",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":77},"100531828","new-approaches-to-nerve-stimulation-therapy-for-bladder-pain-syndrome-100531828","NCT06204874","New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome","Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment of Bladder Pain Syndrome: A Case Series","Inclusion Criteria:\n\n* Female sex\n* Age greater than or equal to 18\n* Diagnosis of Bladder Pain Syndrome as evidenced by score greater than or equal to six on O'Leary-Sant Voiding and Pain Indices\n* DEERS-eligible health care beneficiaries\n\nExclusion Criteria:\n\n* Patients with current enabled implantable neurostimulation (i.e. transcutaneous electrical nerve stimulation unit, Interstim)\n* Current active pelvic or gynecologic malignancy\n* Coagulation disorder\n* Local infection at injection site\n* Sepsis\n* Decompensated cardiac or hemodynamic disorders\n* Neurogenic bladder and patients with spinal cord injury\n* Current pregnancy\n* Structural abnormalities of the spine that prevent performance of the procedure\n* Intravesical onabotulinumtoxin A injection within the last 3 months",{"count":86,"type":22},5,[54],"Many women suffer from bladder pain syndrome (BPS). There are many treatments, but there is no one universally effective option. The goal of this clinical trial is to explore the use of electrical energy directed towards a group of nerves, called the superior hypogastric plexus, for treatment of BPS in women over the age of 18 with a diagnosis of BPS. The main question it aims to answer is: does use of electrical micro-current directed at the superior hypogastric plexus improve pain associated with BPS?\n\nThere is data from many different studies that suggest that this kind of therapy might provide relief of BPS symptoms.\n\nParticipants will be asked to participate for a total of six months from the date of their first nerve treatment. At the first appointment, they will be evaluated in the Walter Reed Chronic Pain clinic and asked several questions about the severity and personal management of their symptoms. The procedure will then be performed by inserting two needles into the back (one on either side of the spine) and directing extremely short bursts of electrical micro-current towards the target nerve. The medical term for this is \"pulsed radiofrequency ablation.\" This procedure causes disruption on a microscopic level of nerve fibers that send pain sensations to the bladder and other organs in the pelvis. Following this initial appointment, participants will be asked about their symptoms at 1-, 3-, and 6-month follow-up appointments. Participants will be asked about pain, mood symptoms, sexual function, and measures of bladder irritation. The procedure will only be performed once.\n\nAt the study conclusion, researchers will analyze pain scores, as well as other secondary outcomes listed above.\n\nBenefits of this study may include possible relief of BPS symptoms. This may help to advance research about treatments for BPS. This is a novel approach to the treatment of BPS and as such may provide benefits greater than those found in treatment outside of the study.",[28],"2026-04-25",{"date":92,"type":35},"2026-04-30",{"date":94,"type":35},"2024-01-01",{"date":96,"type":22},"2026-12",{"name":98,"class":99},"Walter Reed National Military Medical Center","FED",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":19,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":77},"100517123","efficacy-of-pulsed-electromagnetic-field-and-heparinbupivacaine-instillations-100517123","NCT06013449","Efficacy of Pulsed Electromagnetic Field and Heparin\u002FBupivacaine Instillations","Investigation of the Effect of Simultaneous Pulsed Electromagnetic Field (PEMF) and Intravesical Heparin - Bupivacaine Cocktail Instillation for the Symptomatic Treatment of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","Inclusion Criteria:\n\n* Previously established clinical diagnosis of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)\n* Current Numeric Rating Scale (NRS) greater than or equal to 5\n* History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia\n* No contraindications to the instillation solution\n* No cognitive deficits\n\nExclusion Criteria:\n\n* History of bladder, ovarian or vaginal cancer\n* History of urethral diverticulum\n* History of radiation cystitis\n* History of spinal cord injury or spina bifida\n* History of Parkinson's Disease\n* History of Multiple Sclerosis (MS)\n* History of Stroke\n* History of genital herpes\n* History of or current cyclophosphamide treatment\n* Current placement of a pacemaker or metal prothesis\n* Active urinary tract infection\n* BMI \\>40\n* Residual urine of \\>100 cc\n* Currently pregnant",{"count":108,"type":22},20,[54],"The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and\u002For associated symptoms of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS) patients. The study team will distribute the PEMF device to female adults with IC\u002FBPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC\u002FBPS than instillations alone.",[30,57,28],[59,60,62,113,64,65,66,114,115],"chronic pelvic pain","PEMF","bladder instillation","2026-03-30",{"date":118,"type":35},"2026-03-31",{"date":120,"type":22},"2026-09",{"date":122,"type":22},"2027-12",{"name":76,"class":42},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":77},"100628296","phase-2-the-study-is-being-conducted-to-find-a-new-treatment-for-patients-suffering-from-interstitial-cystitis-with-hunners-lesions-100628296","NCT07459790","The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions","Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome\u002FInterstitial Cystitis (BPS\u002FIC) With Hunner's Lesions","Inclusion Criteria:\n\n1. Written informed consent prior to any study-related procedures.\n2. Women aged 18 to 65 years, inclusive.\n3. A confirmed diagnosis of painful bladder syndrome\u002Finterstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.\n4. The presence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).\n5. A glycated hemoglobin level within the normal range for the patient's age group.\n6. Ability to comply with all study requirements, in the opinion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.\n7. Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.\n\nExclusion Criteria:\n\n1. Any condition that prevents intravesical administration of medications.\n2. Received medication or non-medication therapy, including physical therapy, for BPS\u002FIC within 1 month prior to study inclusion.\n3. Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.\n4. History of chronic drug or alcohol abuse.\n5. Pregnant women, planning to become pregnant during the study, or currently breastfeeding.\n6. Any other conditions associated with pelvic pain, except for PBS.\n7. Pelvic surgery less than 6 months prior to the study.\n8. Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening.\n9. History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.\n10. Inability to discontinue anticoagulant\u002Fantiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low molecular weight heparin may be used for 3 days after investigational drug administration).\n11. Diseases of the urinary tract\u002Fbladder (neoplasms, tuberculous and bacterial cystitis, urolithiasis, radiation injury, urethral diverticulum, neurogenic dysfunction of the lower urinary tract) and female genital organs (neoplasms, vaginitis, genital infections).\n12. Other conditions that, in the opinion of the research physician, could become an objective obstacle to the patient's participation in the study and\u002For create additional risks for the patient.\n13. A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.\n14. Bladder capacity under anesthesia less than 150 ml.\n15. Residual urine volume greater than 50 ml.","65 Years",{"count":133,"type":22},180,[135,136],"PHASE2","PHASE3","To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis with Hunner's lesions to reduce cicatricial changes in the bladder caused by electrocoagulation and to prevent secondary bladder shrinkage with a decrease in its volume.",[139,140,28],"IC","Hunner Type Interstitial Cystitis","2026-03-09",{"date":143,"type":35},"2026-03-10",{"date":145,"type":35},"2023-12-29",{"date":147,"type":22},"2027-10-30",{"name":149,"class":42},"JSC NextGen",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100449064","eppic-easing-pelvic-pain-interventions-clinical-research-program-100449064","NCT05127616","EPPIC: Easing Pelvic Pain Interventions Clinical Research Program","A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes","EPPIC","Inclusion Criteria:\n\n* Ages 18-70 years (inclusive)\n* Male or female\n* All genders, races, ethnic groups\n* MD-confirmed diagnosis of IC\u002FBPS or CP\u002FCPPS by study urologist or urogynecologist\n* Pelvic pain including uncomfortable sensations of pressure or discomfort that are not described as outright pain) of at least six months duration\n* Pelvic pain intensity of at least moderate severity (defined as 3 or greater on a 0-10 Numerical Rating Scale and causes life interference weekly and limit(s) participant's life or work-related activities, general activity level, and\u002For enjoyment of life) over the past 3 months.\n* Ability to understand and provide informed consent\n* Either not taking medications or if taking medications willing to refrain from starting new medications until after the initial 2-week pre-treatment baseline period ends unless medically necessary.\n* A minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT 4)\n* Willing to be randomized to either CBT or Support\u002FEducation and to follow the protocol to which s\u002Fhe has been assigned\n* Willing to be contacted for follow up assessments at week 12 and 3, 6 months after treatment ends\n* Willing to attend sessions\n* Able to maintain symptom diaries and complete paper work\n* Access to telephone and computer or smartphone\n* Willing and able to provide adequate information for locator purposes\n\nExclusion Criteria: Urologic-Specific\n\n* Presence of a neurological condition (e.g., MS, Parkinson's disease, paraplegia) affecting the bladder\n* The presence of a symptomatic urethral stricture (males only)\n* History of cystitis caused by tuberculosis or radiation or chemotherapies\n* Participant has been diagnosed and treated for a pelvic-related malignancy (colon, bladder, prostate, ovarian, endometrial, uterine, testicular, penile, cervical, vaginal, or rectal cancer)\n\nExclusion Criteria: General\n\n* Participant has a medical condition(s) whose nature or severity (unstable, life threatening, etc.) would influence adversely the conduct of the clinical trial, confound interpretation of study results, and\u002For compromise volunteer safety and engagement with study demands.\n* Gross cognitive impairment, deafness, blindness, vision problems (severe), hearing problems (severe)\n* Has a major psychiatric disorder which would impede conduct of the clinical study. These clinical disorders would include but are not limited to major depression with a high risk of suicidal behavior (i.e. intent or plan), current or recent (within the past 3 months) history of alcohol or substance abuse\u002Fdependence, a lifetime history of schizophrenia or schizoaffective disorder; or organic mental disorder\n* Current involvement in psychotherapy directed specifically toward relief of urological symptoms\n* Schedule does not permit participation in clinic sessions or home practice including plans to move out of the area, lack of reliable transportation, etc.\n* Characteristics related to inability to complete the study protocol\n* Unable to read or fluently speak English\n* Inability to complete screening visits\n* Inaccessible for interventions and\u002For follow up evaluations","70 Years",{"count":160,"type":22},240,[54],"The EPPIC (Easing Pelvic Pain Interventions Clinical Research Program) study evaluates an ultra-brief, 4 session cognitive behavioral pain treatment transdiagnostic in design for urologic chronic pain syndrome (UCPPS) with clinical and practical advantages over existing behavioral therapies whose length and focus limits their adoption by clinicians and coverage for mechanistically similar comorbidities. A theoretically informed, practical, empirically grounded approach will systematically unpack CBT's working mechanisms, clarify for whom it works, ease dissemination, appeal to patients, providers, payers, and policy makers in the COVID-19 era favoring low resource intensity treatments, and reduce cost and inefficiencies associated with high intensity therapies whose complexity, length, and scarcity restricts uptake and impact.",[164,30,28,165,166,167,168],"Urologic Chronic Pelvic Pain Syndrome (UCPPS)","Chronic Prostatitis","Chronic Pain","Chronic Pelvic Pain Syndrome","Chronic Overlapping Pain Disorders","2026-01-22",{"date":171,"type":35},"2026-01-26",{"date":173,"type":35},"2022-08-10",{"date":175,"type":22},"2028-07-31",{"name":177,"class":42},"State University of New York at Buffalo",3,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":86},"100546430","phase-2-safety-efficacy-and-frequency-of-administration-of-vnx001-in-the-treatment-of-interstitial-cystitis--bladder-pain-syndrome-icbps-100546430","NCT06394830","Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis \u002F Bladder Pain Syndrome (IC\u002FBPS)","A Phase 2b, Open Label, Single-Arm, Multi-Center, Multiple Dose, 14-Day Study to Evaluate the Safety, Efficacy, and Frequency of Intravesical Administration of VNX001 in Acute Treatment of Subjects With Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS) Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity","Inclusion Criteria:\n\n1. Enrolled and completed Study VNX001-111 (i.e., at any site that is concurrently conducting the VNX001-111 study, a subject must have previously enrolled and completed Study VNX001-111 to be eligible for entry into the VNX001-110 study) and meet all other inclusion\u002Fexclusion criteria.\n2. Be able and willing to give a signed informed consent and to follow study instructions.\n3. Be male or female, ≥ 18 years of age.\n4. Have a history of IC\u002FBPS for at least 9 months prior to the study, either treated (e.g. Elmiron®, RIMSO-50®), or untreated.\n5. Have received a cystoscopy in association with their diagnosis of IC\u002FBPS within 1 year of screening.\n6. Have a score of ≥ 14 and ≤ 30 on the PUF questionnaire, completed at screening.\n7. Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 4 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration.\n\nExclusion Criteria:\n\n1. For females, have a positive pregnancy test at screening or be pregnant or lactating.\n\n   Note: Females considered to be of child-bearing potential must commit to using a consistent and medically acceptable method of birth control for the duration of the study: hormonal (i.e., oral, transdermal patch, implant, or injection) on a stable dose for at least 3 months prior to screening; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to screening; and intrauterine device for at least 3 months prior to screening; or only have a partner who has been vasectomized for at least 6 months prior to screening or exclusively has same-sex partners. Female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation. Females considered to be of non-childbearing potential include: At least 1 year postmenopausal; surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, of hysterectomy); congenitally sterile; diagnosed as infertile and not undergoing treatment to reverse infertility.\n2. Males who are sexually active with females and are not willing to commit to an acceptable method of birth control for the duration of the study.\n3. Postmenopausal women who, if taking hormone replacement therapy, have not been stabilized on a regimen of hormone replacement therapy within 3 months of screening.\n4. Have a known hypersensitivity to heparin or lidocaine.\n5. Have used any local anesthetic by any route (other than intravesical instillation) within 48-hours prior to study drug administration, or used a lidocaine patch or lidocaine containing topical compounds within 14 days prior to study drug administration.\n6. Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day.\n7. Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results.\n8. Have a known abnormal laboratory test value that, in the investigator's judgement, is clinically significant.\n9. Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage).\n10. Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain.\n11. Have any of the following central nervous system (CNS) conditions that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results, severe diagnosed: major depressive disorder, bipolar disorder, schizophrenia, general anxiety disorder, attention deficit disorder, obsessive compulsive disorder, or other major CNS disorder.\n12. Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results.\n13. Had bladder instillation therapy within 14 days prior to study entry.\n14. Had an in-office cystoscopy within 7 days prior to study drug administration.\n15. Had dilatation (hydrodistension) of bladder within 3 months of study entry.\n16. Evidence or suspected presence of cancer detected during cystoscopy.\n17. Has received any investigational drug or device within 30 days prior to screening.\n18. Is currently enrolled in another investigational drug or device study.\n19. Is unwilling or unable to abide by the requirements of the study.\n20. Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization (Section 9.5.1.6). If the investigator determines that active bleeding is not occurring and that it is safe for the subject, the subject may continue in the study.\n21. Have a history of coagulopathy or taking anticoagulants.\n22. Are taking any of the following medications:\n\n    * Phenytoin\n    * Carbamazepine\n    * St. John's Wort\n    * Phenobarbital\n    * Rifampin\n23. Have had any of the following:\n\n    * Bacterial cystitis within 30 days as demonstrated by a positive urine culture (≥ 105 bacteria per mL)\n    * History of pelvic irradiation or radiation cystitis\n    * History or presence of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer\n    * History of benign or malignant bladder tumors\n    * Current chemotherapy\n    * History or presence of tuberculous cystitis\n    * History or presence of chemical cystitis, including that due to cyclophosphamide\n    * History or presence of urinary schistosomiasis\n    * Bladder or ureteral calculi\n    * Clinically significant infectious vaginitis\n    * Currently uncontrolled genital herpes\n    * History or presence of urethral diverticulum\n    * Presence of bladder fistulae\n    * History of ketamine use",{"count":187,"type":22},50,[135],"This is an open-label study that will enroll participants with Interstitial Cystitis \u002F Bladder Pain Syndrome (IC\u002FBPS).\n\nThe study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001.\n\nParticipants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening\u002Fdosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.",[30,28],[192,193,194,195,196,197],"interstitial cystitis (IC)","bladder pain syndrome (BPS)","alkalinized lidocaine","heparin","intravesical","VNX001","2026-01-21",{"date":169,"type":35},{"date":201,"type":35},"2024-12-13",{"date":203,"type":22},"2026-06",{"name":205,"class":206},"Vaneltix Pharma, Inc.","INDUSTRY",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":224,"locationsCount":225},"100495893","phase-2-safety-and-efficacy-study-of-vnx001-compared-to-its-individual-components-lidocaine-and-heparin-or-placebo-in-subjects-with-icbps-100495893","NCT05737121","Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC\u002FBPS","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of VNX001 Compared to Placebo, and the Individual Components of Lidocaine, and Heparin in Subjects With Interstitial Cystitis\u002FBladder Pain Syndrome Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity; The Engage 2024 Study","Inclusion Criteria:\n\n* Be able and willing to give a signed informed consent and to follow study instructions\n* Be male or female, ≥ 18 years of age\n* Have a history of IC\u002FBPS for at least 9 months prior to the study\n* Have a score of ≥ 16 and ≤ 30 on the Pelvic Pain and Urgency\u002FFrequency (PUF) questionnaire, completed at screening\n* Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 5 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration.\n* Have previously received a therapeutic intravesicular anesthetic treatment according to medication history\n\nExclusion Criteria:\n\n* For females, have a positive pregnancy test at screening or be pregnant or lactating\n* Males who are sexually active with females and are not willing to commit to an acceptable method of birth control for the duration of the\n* Postmenopausal women who, if taking hormone replacement therapy, have not been stabilized on a regimen of hormone replacement therapy within 3 months of screening\n* Have a known hypersensitivity to heparin or lidocaine\n* Have used any local anesthetic by any route within 48-hours prior to study drug administration, or used a lidocaine patch or lidocaine containing topical compounds within 14 days prior to study drug administration\n* Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day\n* Have used any pain medication within 6 hours prior to study drug administration\n* Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry\n* Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results\n* Have a known abnormal laboratory test value that, in the investigator's judgement, is clinically significant.\n* Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage)\n* Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain\n* Have any of the following central nervous system (CNS) conditions that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results, severe diagnosed: major depressive disorder, bipolar disorder, schizophrenia, general anxiety disorder, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder\n* Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results\n* Had anesthetic bladder instillation therapy within 14 days prior to study entry\n* Had an in-office cystoscopy within 7 days of study drug administration\n* Had dilatation (hydrodistension) of bladder within 3 months of study entry\n* Evidence or suspected presence of cancer detected during cystoscopy 7 days prior to or at time of initial screening\n* Has received any investigational drug or device within 30 days prior to screening\n* Is currently enrolled in another investigational drug or device study\n* Is unwilling or unable to abide by the requirements of the study\n* Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization\n* Have a history of coagulopathy or taking anticoagulants.\n* Are taking any of the following medications, which are inducers of CYP1A2 and\u002For CYP3A4: Phenytoin, Carbamazepine, St. John's Wort, Phenobarbital, Rifampin\n* Have had any of the following:\n\n  * Bacterial cystitis within 30 days as demonstrated by a positive urine culture (≥ 105 bacteria per mL)\n  * History of pelvic irradiation or radiation cystitis\n  * History or presence of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer\n  * History of benign or malignant bladder tumors\n  * Current chemotherapy\n  * History or presence of tuberculous cystitis\n  * History or presence of chemical cystitis, including that due to cyclophosphamide\n  * History or presence of urinary schistosomiasis\n  * Bladder or ureteral calculi\n  * Clinically significant infectious vaginitis\n  * Currently uncontrolled genital herpes\n  * History or presence of urethral diverticulum\n  * Presence of bladder fistulae\n  * History of ketamine use",{"count":215,"type":22},120,[135],"This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center, single-dose, pharmacodynamic study designed to evaluate the efficacy and safety of the combination product (VNX001) versus placebo and its individual components (heparin sodium and lidocaine hydrochloride (HCl)) for the reduction of bladder pain in patients with interstitial cystitis (IC) \u002F bladder pain syndrome (BPS), Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity.",[30,28],[192,193,194,195,196,197],{"date":169,"type":35},{"date":222,"type":35},"2023-05-22",{"date":203,"type":22},{"name":205,"class":206},14,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":245,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":77},"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":234,"type":22},220,[54],"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.",[57,28,238,239,240,30,241,242,243,165,244],"Painful Bladder Syndrome","Cystitis, Interstitial","Cystitis, Chronic Interstitial","Interstitial Cystitis, Chronic","Interstitial Cystitis (Chronic) With Hematuria","Interstitial Cystitis (Chronic) Without Hematuria","Chronic Prostatitis With Chronic Pelvic Pain Syndrome",[59,60,246,247,248,249,250,251,252,253,254],"clinical trial","psychosocial intervention","pelvic pain","therapy","urological chronic pelvic pain syndrome","chronic prostatitis","self-management","cognitive behavioral therapy","pelvic floor physical therapy","2026-01-20",{"date":198,"type":35},{"date":258,"type":35},"2024-05-01",{"date":260,"type":22},"2028-04-04",{"name":262,"class":42},"Vanderbilt University Medical Center",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":77},"100544237","acupuncture-first-for-icbps-100544237","NCT06366269","Acupuncture First for IC\u002FBPS","Acupuncture as First-line Therapy for Patients With Interstitial Cystitis\u002FPainful Bladder Syndrome","Inclusion Criteria:\n\n* Meets American Urologic Association (AUA) criteria for interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS): \"An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause\"\n* Negative urine culture\n* Has completed cystoscopic evaluation for IC\u002FBPS\n\nExclusion Criteria:\n\n* History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)\n* History of overactive bladder\n* History of bleeding disorder or are currently on chronic anti-coagulation\n* Post-void residual \\>100mL\n* Has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (PTNS), sacral neuromodulation, or intradetrusor Botox\n* Prior bladder augmentation\n* Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy\n* Currently pregnant (if applicable, based on self-report)\n* Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)\n* Non-English speaking and reading","89 Years",{"count":272,"type":22},34,[54],"The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:\n\nDoes acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.\n\nParticipants will\n\n* complete surveys about their bladder pain symptoms\n* make behavioral changes that have been shown to improve bladder pain symptoms\n* attend six (6) weekly acupuncture sessions\n* attend six (6) weekly physical therapy sessions after finishing acupuncture",[28,30],[277,60,59],"acupuncture","2026-01-06",{"date":280,"type":35},"2026-01-08",{"date":282,"type":35},"2025-01-21",{"date":284,"type":22},"2026-10",{"name":286,"class":42},"University Hospitals Cleveland Medical Center",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":294,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":297,"phases":4,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":77},"100086864","identifying-genetic-causes-of-icbps-100086864","NCT00389142","Identifying Genetic Causes of IC\u002FBPS","Genetic Studies in Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","Inclusion Criteria:\n\n* Diagnosis of IC\u002FBPS\n* Males and females of any age\n* Urinary frequency - more than 1X\u002Fhour, and\u002For\n* Dysuria, and\u002For\n* Pelvic, suprapubic, or abdominal pain - for 3 months or longer\n* Nocturia\n* Normal urinary stream (by history)\n* No evidence of active bacterial UTI (no pyuria \\& negative urinary culture for last 3 months)\n* First degree relative of someone with above symptoms\n\nExclusion Criteria:\n\n* Major structural\u002Fanatomical urinary tract abnormalities by ultrasound\n* Underlying inborn conditions affecting the urinary tract\n* Surgery\u002Fchemotherapy affected pelvic area\n* GI or GU cancers\n* Severe Constipation in children only","1 Year",{"count":296,"type":22},1000,"OBSERVATIONAL","Interstitial cystitis (IC), also called Bladder Pain syndrome (BPS) is a common condition with no known cause or cure. Twin studies and family accounts have suggested that the condition may be genetic or passed down (inherited) from one generation to another.\n\nIn this study, the investigators are collecting genetic material via blood or saliva and medical information from families in North America in an attempt to identify genetic factors that may cause IC\u002FBPS. The investigators are enrolling inviduals with IC\u002FBPS and their family members (family members with and without IC like symptoms). Travel to Boston not required.",[30,28],[248,65,62,64],"2025-12-09",{"date":303,"type":35},"2025-12-16",{"date":305,"type":35},"2006-01-15",{"date":307,"type":22},"2030-12-31",{"name":309,"class":42},"Boston Children's Hospital",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":77},"100418852","early-phase-1-safety-and-efficacy-of-aloe-vera-in-the-management-of-the-symptoms-of-interstitial-cystitis-100418852","NCT04734106","Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis","A Double-Blind, Placebo-Controlled Study to Establish the Safety and Efficacy of Super-Concentrated, Freeze-Dried Aloe Vera in the Management of the Symptoms of Interstitial Cystitis","Inclusion Criteria:\n\n* Females or males, aged 18 years or older\n* Females of childbearing potential must agree to use acceptable methods of birth control. Acceptable methods are oral and injectable preparations, double barrier, vasectomized partner, or abstinence.\n* Participant must sign and date the informed consent.\n* Participant must report a urinary frequency of at least 11 times per 24-hour day, on average over the previous four weeks.\n* Participant must report a pain\u002Fdiscomfort score of 4 or greater on a 0-9 Likert scale.\n* These reported urinary symptoms of frequency and pain\u002Fdiscomfort must have been present for at least the previous 24 weeks prior to the first baseline screening visit.\n* Participants must report in the baseline voiding diary at least one voided volume greater than or equal to 75cc in a 24-hour period.\n\nExclusion Criteria:\n\n* Known allergy or intolerance to aloe vera in any form as reported by the participant or derived from medical records.\n* History of Bladder tumors (malignant or benign).\n* Current active bladder or urethral calculus.\n* History of urethral cancer within the previous five years.\n* Any disease which, in the opinion of the investigator, may be unstable or have bearing on the outcome of the study, including severe debilitating concurrent medical conditions such as coronary artery disease, azotemia, moderate to severe hepatic insufficiency, etc.\n* Previous treatment with Cytoxan (cyclophosphamide).\n* History of cyclophosphamide or chemical cystitis or tuberculosis or radiation cystitis.\n* History of pelvic radiation treatment, bladder cancer or cancer in situ, or urethral cancer.\n* History of any other neoplastic process currently requiring systemic, nonprophylactic treatment.\n* History of urethral diverticulum.\n* Inability to void spontaneously.\n* Subjects with interstitial cystitis symptoms alleviated by current therapy regimen.\n* Uncontrolled diabetes mellitus.\n* Previous enrollment in an aloe vera study.\n* Previous use of Desert Harvest super-concentrated, freeze-dried aloe vera capsules.\n* Any imminent change in residence that could compromise compliance.\n* Unlikely to be compliant due to unmanaged medical or psychological problem, including dementia, aphasia, or other deficits of cognition or speech\u002Flanguage function that will interfere with the participant's ability to complete the study.\n* Substance abuse or dependency problem within the past two years for which patient received no treatment.\n\nMale-Specific Exclusion Criteria:\n\n* Males with a history of prostate cancer within the previous five years.\n* Males with a prostatic infection within the previous three months.\n\nFemale-Specific Exclusion Criteria:\n\n* Females with a history of uterine, cervical, or vaginal cancer within the previous five years.\n* Pregnant or lactating females.",{"count":318,"type":22},30,[320],"EARLY_PHASE1","The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.",[30,57,28],[324,28,325,326,327,328,329],"Interstitial Cystitis (IC)","Urinary urgency","Urinary frequency","Bladder pain","Nocturia","Urinary incontinence","2025-08-26",{"date":332,"type":35},"2025-08-27",{"date":334,"type":35},"2025-02-18",{"date":336,"type":22},"2027-07",{"name":76,"class":42},{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":77},"100582431","intravesical-ozone-therapy-for-interstitial-cystitisbladder-pain-syndrome-100582431","NCT06863220","Intravesical Ozone Therapy for Interstitial Cystitis\u002FBladder Pain Syndrome","Inclusion Criteria:\n\n* Age 18-65 years\n* Histopathologically or clinically confirmed IC (per AUA guidelines)\n* Symptoms for at least 6 months\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Active urinary tract infection\n* Bladder malignancy\n* Pregnancy or breastfeeding\n* Known ozone allergy\n* Intravesical therapy within 3 months\n* G6PD deficiency",{"count":345,"type":22},60,[54],"This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (IC). Participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. The primary outcome was the change in O'Leary-Sant ICSI score. Secondary outcomes included VAS pain score, SF-36 physical health, and urinary frequency.",[30,28],[30,60,350,351],"ozone therapy","intravesical ozone","2025-04-23",{"date":354,"type":35},"2025-04-27",{"date":356,"type":22},"2025-06-01",{"date":358,"type":22},"2026-06-01",{"name":360,"class":42},"Medipol University",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":368,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":77},"100545854","phase-4-bladder-botox-uti-antibiotic-prophylaxis-100545854","NCT06387329","Bladder Botox UTI Antibiotic Prophylaxis","Urinary Tract Infection Prophylaxis In Intradetrusor OnabotulinumtoxinA Procedures: A Randomized Controlled Trial","Inclusion Criteria:\n\n* All patients 18 years or older being seen at the WRNMMC Urogynecology clinic\n* Diagnosis of OAB or IC\u002FBPS\n* Planning to undergo intradetrusor onabotulinumtoxinA injection for treatment of their OAB or IC\u002FBPS\n* Ability to follow instructions and complete follow up\n\nExclusion Criteria:\n\n* Contraindication to nitrofurantoin (allergy, CrCl \\\u003C30mL\u002Fminute)\n* If performed in the operating room, the patient cannot undergo a concurrent procedure that would increase the risk of UTI or require an alternate antibiotic regimen (such as hysterectomy, prolapse repair, or anti-incontinence procedure)\n* Active UTI at the time of procedure\n* Neurogenic bladder\n* Recurrent UTI (3 in 12 month period or 2 in 6 months)\n* Post void residual bladder volume ≥150mL\n* Patient is already taking antibiotics at the time of the procedure\n* Contraindication to onabotulinumtoxinA (allergy, pregnancy, greater than 400 units of onabotulinumtoxinA received in the last 3 months)",true,{"count":370,"type":22},100,[372],"PHASE4","Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance.\n\nThe population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC\u002FBPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure.\n\nThe patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure.\n\nA urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection.",[375,28],"Overactive Bladder",[377,378,379],"Intradetrusor Onabotulinumtoxin A","Urinary tract infection","Antibiotic prophylaxis","2025-02-14",{"date":382,"type":35},"2025-02-19",{"date":384,"type":35},"2024-04-04",{"date":386,"type":22},"2025-06-30",{"name":98,"class":99},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":396,"targetDuration":4,"studyType":297,"phases":4,"briefSummary":398,"conditions":399,"keywords":406,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":426},"100571359","evaluating-the-efficacy-and-patient-experience-of-catheter-free-intravesical-instillation-100571359","NCT06719232","Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation","Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study","NOCATIN","Inclusion Criteria:\n\n* Male and female patients aged between 18 and 80 years.\n* Patients for whom the treating physician has determined that intravesical instillation is necessary due to one of the following conditions:\n* Interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS).\n* Recurrent urinary tract infections (UTIs).\n* Non-muscle invasive bladder cancer.\n* Post-radiation cystitis.\n* Post-chemotherapy cystitis.\n* Negative urine culture within the last two weeks.\n* Patients who provide verbal and written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Urinary tract infection within the past month or currently active infection.\n* Diagnosed bleeding disorders or recurrent macroscopic hematuria.\n* Post-void residual urine volume greater than 100 ml.\n* Mental condition that prevents reliable cooperation.",{"count":397,"type":22},300,"This study aims to evaluate a catheter-free method for delivering medications directly into the bladder, known as intravesical instillation, which is commonly used to treat conditions such as interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS), recurrent urinary tract infections, bladder cancer, and post-chemotherapy or post-radiation cystitis.\n\nThe study investigates whether this method, which eliminates the need for catheterization, reduces discomfort and complications while maintaining treatment effectiveness. By collecting data on patient experiences and outcomes, the study seeks to determine if this approach provides a safer and more comfortable alternative to traditional catheter-based treatments.",[30,400,401,402,403,404,28,405],"Recurrent Cystitis","Haemorrhagic Cystitis","Bladder Cancer","Bladder Disease","Intravesical Instillation","Recurrent Urinary Tract Infections",[407,408,409,410,411,412,413,414,415],"intravesical therapy","catheterization","recurrent urinary tract infection","IC\u002FBPS","Interstitial Cystitis\u002FBladder Pain syndrome","Post-chemotherapy Cystitis","Post-Irradiation Cystitis","Intravesical instillation","UroDapter","2024-12-07",{"date":418,"type":35},"2024-12-12",{"date":420,"type":35},"2024-10-01",{"date":422,"type":22},"2025-12",{"name":424,"class":425},"Jahn Ferenc South Pest Teaching Hospital","OTHER_GOV",2,{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":368,"sex":50,"minAge":18,"maxAge":433,"enrollmentInfo":434,"targetDuration":436,"studyType":297,"phases":4,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":77},"100572121","effect-of-intradetrusor-onabotulinumtoxina-injection-versus-conservative-management-on-female-sexual-function-in-patients-with-bladder-pain-syndrome-100572121","NCT06729151","Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome","Inclusion Criteria:\n\n* Female 18 years of age and older\n* For bladder pain syndrome participants: O'Leary Sant score 13 or greater\n* For healthy controls: O'Leary Sant score 12 or less\n* DEERS eligible (care provided by military health care system)\n\nExclusion Criteria:\n\n* Contraindications for bladder Botox\n* Current use of alternative treatment for bladder pain syndrome\n* Neurogenic bladder\n* Other urinary tract disease\n* Pelvic organ prolapse stage 3 or greater\n* Pregnancy or breastfeeding\n* Non-English speakers","99 Years",{"count":435,"type":22},159,"12 Weeks","Interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS) is estimated to affect 3.3 to 7.9 million women aged 18 years and older in the United States. The American Urological Association (AUA) defines IC\u002FBPS as \"an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes\". IC\u002FBPS significantly impacts quality of life, with the individual domains of sexual function, anxiety and depression, sleep quality and work productivity being specifically affected. Significant sexual dysfunction in women with IC\u002FBPS has been consistently demonstrated across multiple international studies, with a prevalence ranging from 68% to 91%. In fact, among all patients with lower urinary tract symptoms, patients with a diagnosis of IC\u002FBPS had the highest levels of impaired sexual function, mostly due to dyspareunia. Recommended treatments for IC\u002FBPS include dietary and behavioral modifications, oral medications, bladder instillations, bladder hydrodistension, intradetrusor injection of onabotulinumtoxinA and major surgery. Scant research exists on how treating IC\u002FBPS affects sexual function. We are conducting a prospective cohort study to assess for improvement in sexual function following intravesical onabotulinumtoxinA injection versus conservative management for IC\u002FBPS.\n\nThe study will consist of three groups: intradetrusor onabotulinumtoxinA injection, conservative management and age-matched, healthy controls. All patients aged 18 years and older presenting to the Walter Reed National Military Medical Center (WRNMMC) Urogynecology clinic who are given a diagnosis of IC\u002FBPS and have an O'Leary Sant index questionnaire scoring 13 or greater will be eligible for the study. The primary study outcome is change in the pre- and 12-week post-treatment Female Sexual Function Index (FSFI). The secondary outcomes will include changes in the pre- and post-treatment O'Leary Sant index, Patient Global Impression of Improvement (PGI-I), Patient Global Impression of Severity (PGI-S), Pelvic Organ Prolapse\u002FIncontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), Visual analog pain scale and 24-hour bladder diary (number of daily voids, number of nightly voids, incontinence episode). Adverse events will be monitored, including urinary tract infection or need for urinary catheterization due to urinary retention within 12 weeks of start of treatment. The age-matched, healthy control group will complete only one set of questionnaires to serve as a baseline comparison to the IC\u002FBPS groups. For between-groups comparisons, a sample size of 49 per group will have 80% power to detect a clinically important difference of 4 points if the standard deviation is 7 points, assuming a 5% two-sided significance level. We will therefore recruit 55 subjects per group to allow for approximately 10% attrition between the pre- and post-treatment assessments. This study will be powered to detect a difference between treatments groups, which has not yet been reported in the literature.",[28,439],"Female Sexual Dysfunction","2024-12-06",{"date":442,"type":35},"2024-12-11",{"date":444,"type":35},"2024-11-01",{"date":37,"type":22},{"name":98,"class":99},{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":77},"100460771","ea-for-bps-an-rct-and-study-for-central-mechanism-100460771","NCT05279963","EA for BPS: An RCT and Study for Central Mechanism","Electroacupuncture for Bladder Pain Syndrome: An Randomized Controlled Trial and Study for Central Mechanism","Inclusion Criteria:\n\n* 18 ≤ age ≤70 years, male or female;\n* Must fulfill the first and the second diagnostic criteria;\n* 30 mm≤ VAS score ≤80mm;\n* Participants can fully understand the study protocol and a written informed consent is signed.\n\nExclusion Criteria:\n\n* Patients with previous bladder stones or other space-occupying lesions;\n* Previous positive urine culture or significant abnormal urine routine;\n* Significant organic lesions of genitourinary system and pelvic organs;\n* Patients suffer from severe primary diseases such as cardiovascular, cerebrovascular, respiratory, liver and kidney, or patients cannot receive EA treatment due to any reasons;\n* People with heart stents and other metallic substances in their bodies;\n* Women who are pregnant, planning to become pregnant, breast-feeding or allergic to study drugs;\n* Patients have participated in other clinical trials within the last 3 months.",{"count":455,"type":22},84,[54],"This is a randomized controlled and assessor-blinded design trial to evaluate the efficacy and safety of acupuncture for bladder pain syndrome(BPS). All eligible participants will be randomly assigned to the medication group(n=21), EA group(n=42) and SA group(n=21) in a 1:2:1 allocation ratio. Participants will receive 4-week treatments phase followed by a 4-week follow-up phase. Outcomes will be assessed at baseline, during the treatment and at the end of the follow-up. Outcome assessors, data managers and statisticians will be blinded to the group allocation, while acupuncturists and participants will not be blinded for obvious reasons. Besides, fMRI will be used to collect spontaneous electrical activity of the brain of patients. In this trial, the investigators assume that electroacupuncture for BPS, compared to amitriptyline, is instrumental in improving symptoms such as pain, frequent micturition and emotional disorder.",[28],[460,461,462],"electroacupuncture","Randomized Controlled Trial","multi-modal magnetic resonance imaging","2024-11-28",{"date":465,"type":35},"2024-12-03",{"date":467,"type":35},"2022-03-16",{"date":469,"type":22},"2025-01-23",{"name":471,"class":42},"The Third Affiliated hospital of Zhejiang Chinese Medical University",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":480,"studyType":297,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":489,"locationsCount":77},"100538754","fmri-for-bps-a-descriptive-study-of-findings-and-symptoms-100538754","NCT06294951","fMRI for BPS: A Descriptive Study of Findings and Symptoms","Functional Magnetic Resonance Imaging Findings and Symptoms in Bladder Pain Syndrome: A Descriptive Study","Inclusion Criteria for BPS group:\n\n1. Be 18 years of age or older and female;\n2. Be diagnosed with BPS (persistent or recurrent pain in the bladder area accompanied by at least one other symptom, such as increased pain when the bladder is full, and frequent urination during the day and\u002For at night, according to the current diagnostic criteria and clinical guidelines, without any of the conditions listed in the \"Exclusion Criteria\" below);\n3. Persistence of symptoms for more than 6 months;\n4. Visual analogue scale (VAS) of pain ≥ 4;\n5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) score of 12 or more, with pain and nocturia domain scores \\>2;\n6. Pelvic Pain and Urgency\u002FFrequency Patient Symptom Scale (PUF) \\>13;\n7. No history of cystoscopy within 2 years.\n\nExclusion Criteria for BPS group:\n\n1. With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;\n2. Pregnant or lactating women;\n3. Contraindications to MRI;\n4. Average urine output less than 40 ml or more than 400 ml;\n5. Haematuria (more than 1+ in urine dipstick test);\n6. Evidence of current urinary tract infection at the time of recruitment;\n7. Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;\n8. Recurrent urinary tract infection;\n9. History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;\n10. History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;\n11. Reliance on catheterisation; including clean intermittent catheterisation or indwelling catheterisation;\n12. Planned rehabilitation therapy affecting bladder function.\n\nInclusion Criteria for Control group:\n\n1. Be 18 years of age or older and female;\n2. With symptoms of bladder pain (defined as persistent or recurrent pain in the bladder area accompanied by at least one other symptom, such as increased pain when the bladder is full, and frequent urination during the day and\u002For at night) according to current diagnostic criteria and clinical guidelines;\n3. Have a pain visual analogue scale (VAS) ≥ 4;\n4. Evidence of a current urinary tract infection;\n5. Pelvic Pain and Urgency\u002FFrequency Patient Symptom Scale (PUF) \\>13;\n6. No history of cystoscopy within 2 years.\n\nExclusion Criteria for Control group:\n\n1. With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;\n2. Pregnant or lactating women;\n3. Contraindications to MRI;\n4. Average urine output less than 40 ml or more than 400 ml;\n5. Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;\n6. History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;\n7. History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;\n8. Dependence on catheterisation; including clean intermittent catheterisation or indwelling catheterisation;\n9. Planned rehabilitation that affects bladder function.",{"count":215,"type":22},"7 Days","The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:\n\n1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.\n2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.\n\nParticipants will undergo fMRI as well as other routine laboratory tests and queries.",[28],"2024-03-05",{"date":485,"type":35},"2024-03-06",{"date":487,"type":22},"2024-03-01",{"date":37,"type":22},{"name":490,"class":42},"RenJi Hospital"]