[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pelvic-floor-relaxation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pelvic-floor-relaxation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100444090","early-phase-1-a-novel-medical-system-for-quantitative-diagnosis-and-personalized-precision-botulinum-neurotoxin-injection-in-chronic-pelvic-pain-management-100444090",false,"NCT05062902","A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management","An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management","Inclusion Criteria:\n\n* Inclusion criteria for interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS) patients will be:\n\n  1. Woman aged 18 to 60.\n  2. Have a clinical diagnosis of IC\u002FBPS.\n  3. Pain, pressure, or discomfort in the bladder and\u002For pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., urinary tract infection).\n  4. Myofascial pain diagnosed with palpable contracted muscle fibers.\n  5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.\n  6. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \\> 35 cm∙H2O).\n  7. Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Exclusion criteria consist of the following:\n\n  1. History of pelvic malignancy and sexually transmitted diseases.\n  2. Bleeding disorder such as coagulopathy\n  3. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.\n  4. Pregnancy, breast feeding or desiring for pregnancy in the coming year.\n  5. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),\n  6. Pelvic malignancy (urinary tract, gynecologic, gastrointestinal)\n  7. Active fistula\n  8. Radiation cystitis\n  9. Cyclophosphamide cystitis\n  10. Pre-existing anorectal disorders\n  11. Infections near the injection sites\n  12. History of drug or alcohol abuse\n  13. Hypersensitivity to BoNT\n  14. Steroids or hormone usage will be carefully considered by the research team for inclusion.\n\nParticipants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.","FEMALE","18 Years","60 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).",[27,28,29,30],"Interstitial Cystitis","Chronic Pain","Pelvic Floor; Relaxation","Pelvic Floor Disorders",[32,33,34],"hypertonicity","chronic pelvic pain","electromyography","NOT_YET_RECRUITING","2025-08-14",{"date":38,"type":39},"2025-08-19","ACTUAL",{"date":41,"type":21},"2025-09-15",{"date":43,"type":21},"2027-12-01",{"name":45,"class":46},"HillMed Inc.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":47},"100524926","effects-of-pelvic-floor-training-in-male-chronic-pelvic-pain-correlation-between-subjective-and-objective-outcomes-100524926","NCT06115083","Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes","Long Term Effects of Pelvic Floor Re-education in Men With Chronic Pelvic Pain, Using Bio-feedback and Home Training - Subjective Outcomes in Correlation to Objective Measurements of the Lower Urinary Tract and Pelvic Floor","Inclusion Criteria:\n\n* Men over the age of 18, residents in Sweden, diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) (N41.1 (chronic prostatitis), N41.9 (Inflammatory disease of prostate, unspecified), N50.8F (Chronic Pelvic Pain Syndrome in men)\n\nExclusion Criteria:\n\n* Cancer in the abdomen or pelvic organs (current or previous)\n* Congenital anomalies affecting the pelvic region (Bladder exstrophy, Myelomeningocele etc.)\n* Transsexual male, (i.e. at birth biologically female)\n* Diseases affecting the nerve function to the pelvic and\u002For lower extremities, other disease or ongoing treatment that could have an impact on the outcome of the study.\n* Incapability to participate in testing or follow training instructions due to mental incapacity, language difficulties etc.","MALE",{"count":57,"type":21},40,[59],"NA","The goal of this randomized controlled study is to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with chronic pelvic pain. The main questions it aims to answer are if pelvic floor re-education using bio-feedback and home training will give a long-lasting improvement in symptoms, assessed with a validated symptom score (the National Institute of Health - Chronic Prostatitis Symptom Index) and if an improvement in symptoms can be correlated to objective measurements of pelvic floor function. Participants will be asked to do pelvic floor exercises daily during six months with additional sessions of bio-feedback training. The control group will have no changes in their on-going treatment for their chronic pelvic pain and will be offered to enter the treatment group after six months.",[62,63,64,29],"Chronic Pelvic Pain Syndrome","Chronic Prostatitis With Chronic Pelvic Pain Syndrome","Chronic Prostatitis",[66,67,68,69,70,71,72],"Chronic pelvic pain syndrome","Chronic prostatitis with chronic pelvic pain syndrome","Chronic prostatitis","Pelvic floor muscles","Urodynamics","Physiotherapy","Bio-feedback","RECRUITING","2024-04-12",{"date":76,"type":39},"2024-04-16",{"date":78,"type":39},"2023-12-01",{"date":80,"type":21},"2026-12",{"name":82,"class":83},"Region Stockholm","OTHER_GOV"]