[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sacral-neuromodulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sacral-neuromodulation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,74,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100549500","evaluation-of-autonomic-nervous-system-changes-in-response-to-stimulation-by-sacral-neuromodulation-100549500",false,"NCT06434831","Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation","ESTIME","Inclusion Criteria:\n\n* Male of female ≥ 18 years\n* OAB syndrome\n* Indication for a two-staged SNM\n* Under general anaesthesia with Remifentanil and Propofol\n* Patient who has given written consent to participate in the trial\n* Patient willing to comply with all study procedures and duration\n\nExclusion Criteria:\n\n* Tibial neuro-stimulation (last 3 months)\n* Sacral neuromodulation (last 3 months)\n* Botulinum toxin A intra-detrusor injection (last 9 months)\n* Pregnancy in progress\n* Administrative reasons\n* Guardianship\u002Fcuratorship","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.\n\nThe mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.\n\nThe aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.",[26,27],"Bladder Hyperactivity","Sacral Neuromodulation",[29,30,31,32,33],"Bladder hyperactivity","autonomic nervous system","sacral neuromodulation","urodynamic assessment","heart rate variability","RECRUITING","2026-04-29",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":38},"2024-02-14",{"date":42,"type":20},"2026-12-02",{"name":44,"class":45},"University Hospital, Lille","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100468520","sacral-neuromodulation-for-neurogenic-lower-urinary-tract-bowel-and-sexual-dysfunction-100468520","NCT05380856","Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction","Sacral Neuromodulation for Patients With Multiple Sclerosis With Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial.","Inclusion Criteria:\n\n* Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100 means maximal satisfaction with the current treatment). All patients indicating satisfaction less than 50 are considered non-responders\u002Fhaving refractory overactive bladder (OAB) to current treatment\n* No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker.\n* Patients having refractory nLUTD who intend to try SNM for relief of their symptoms\n* Expanded Disability Status Scale (EDSS) \\\u003C 5 and no progression of neurological disease within 6 months\n* Written informed consent\n* Able to understand the information given about the project\n\nExclusion Criteria:\n\n* EDSS \\> 5, neurological disease with severe progression within the last 6 months and\u002For unable to manage the electronic devices\n* Age \\\u003C 18 years\n* Any other urological pathology but nLUTD\n* Bladder Pain Syndrome\u002FInterstitial cystitis\n* Any other intestinal or gynecological pathology but neurological conditional symptoms\n* Current pelvic malignancy or clinically significant pelvic mass\n* Previous pelvis radiotherapy\n* Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial\n* Unable to manage the electronic devices\n* Inability to give an informed consent","80 Years",{"count":56,"type":20},60,[23],"A multi-center double-blinded placebo-controlled randomized clinical trial.\n\nThe patients will be randomized into two groups.\n\nTo investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD).\n\nAfter first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF.\n\nPeriod of randomization: four months. Number anticipated to be included: 60 patients",[60,61,27,62,63,64],"Neurogenic Dysfunction of the Urinary Bladder","Multiple Sclerosis","Bowel Dysfunction","Sexual Dysfunction","Quality of Life","2025-03-17",{"date":67,"type":38},"2025-03-20",{"date":69,"type":38},"2023-09-26",{"date":71,"type":20},"2027-03-01",{"name":73,"class":45},"Odense University Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100508644","diversity-in-patients-with-oab-100508644","NCT05903105","Diversity in Patients With OAB","The Preference of a Culturally and Linguistic Diverse (CALD) Population for Second Line OAB Therapy: a Discrete Choice Experiment","DOAB","Inclusion Criteria:\n\n* OAB\n* Adult\n\nExclusion Criteria:\n\n* SNM or Botox in history",{"count":83,"type":20},1000,"OBSERVATIONAL","An overactive bladder (OAB) is a condition characterized by frequent en nightly voiding, small bladder capacity and the occurrence of sudden urge to void, with or without urinary incontinence. The prevalence of OAB with bothersome complaints is around 11% in women and 9% in men with an increasing incidence with age. OAB is not an illness or disease but nevertheless had a significant impact on both the individual as society. First-line treatment for OAB consists out of behavioral and physiotherapy. Anticholinergic medication can be associated to improve bothersome symptoms, but has the downside of causing unwanted side effects. If the formentioned treatment is not sufficient, second line treatment can be discussed. Depending on the patient's characteristics and the physician's preference intravesical injections of Botox or the implantation of a sacral neuromodulator (SNM) can be considered.\n\nBoth options are equal and effective, but many individual differences exist in preference. Regarding outcome, some factors have been described to prefer one therapy above the other, for example in case of concomitant fecal incontinence, frequent urinary tract infections,… The personal preference of doctors and patients has been investigated, but currently no study has focused on therapy preference in a culturally and linguistic divers (CALD) population. The latter broadly describes a population with ethnical, cultural, religious and\u002For language characteristics and is a general accepted measure of diversity.\n\nIn the current study, the investigators aim to describe the different (dis)advantages of both second line treatments for OAB in a discrete choice experiment. The study population will consist of a diverse group of patients with OAB from different hospitals. The goal is to investigate if CALD patients make a different choice in treatment and what factors contribute to that decision in order to provide more tailored information regarding the treatment options in the future. Taking a patient's context into account in the shared decision making between a patient and physician increases therapy compliance and satisfaction of the chosen treatment.\n\nThe total questionnaire will consist out of general demographic info, the EQ-5D, the International Consultation on Incontinence Questionnaire (ICIQ)-OAB and the discrete choice questionnaire in which patients make a choice between two fictional treatment options consisting of a combination of different therapy characteristics. The questionnaire will be translated into different languages in order to lower the threshold for participation.",[87,88,89,27,90],"Overactive Bladder","Diversity","Onabotulinum Toxin A","Discrete Choice Experiment","NOT_YET_RECRUITING","2024-10-28",{"date":94,"type":38},"2024-10-30",{"date":96,"type":20},"2025-01",{"date":98,"type":20},"2025-12",{"name":100,"class":45},"University Hospital, Ghent",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":46},"100558619","efficacy-of-sacral-nerve-modulation-on-urinary-and-defecation-dysfunction-after-spinal-cord-injurya-prospective-single-arm-study-100558619","NCT06553469","Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study","Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury","Inclusion Criteria:\n\n* Age over 18 years old, gender not limited\n* Diagnosed with urinary and defecation dysfunction caused by spinal cord injury\n* Urodynamic examination suggests bladder dysfunction\n* ASIA spinal cord injury classification: B, C, or D\n* Safe bladder capacity\\>100ml\n* Patients who can undergo sacral nerve regulation surgery after evaluation\n* If you plan not to combine medication during the study period, you need to stop taking the medication for at least 7 days before the screening period. If you plan to continue drug treatment during the study period, you need to maintain the same dosage or stop taking the medication after evaluation by a doctor.\n* Voluntarily participate in this clinical study, and the subjects sign a written informed consent form before the start of the study.\n* After testing treatment, if any of the following conditions are met, permanent implantation of a sacral nerve stimulator is feasible① The average daily frequency of urination during the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline;② The average urinary urgency score for the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline; ③ The number of urinary incontinence episodes in the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline;④ The average urine output per session during the last 3 days of experiential therapy increased by ≥ 50% compared to baseline;⑤ The patient requires permanent implantation due to improvement in intestinal and sexual function, and after evaluation by the researcher, can undergo phase II treatment\n\nExclusion Criteria:\n\n* Other causes of lower urinary tract dysfunction cannot be ruled out, or other diseases that may lead to lower urinary tract dysfunction cannot be ruled out\n* Pregnant women, lactating women, women of childbearing age who plan to conceive or have no safe contraceptive measures during the study period\n* Patients with mental and cognitive impairments, as well as those who are unable to cooperate with the experimental process\n* Patients with untreated infections, coagulation disorders, malignant tumors, and other serious illnesses\n* Individuals who have undergone other relevant surgical treatments within 3 months prior to enrollment (including but not limited to bladder wall injection of botulinum toxin type A), or have participated in other clinical trials\n* Other situations that researchers consider inappropriate to participate in the study",{"count":109,"type":20},41,"The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. We will use urodynamic examination results such as maximum bladder capacity and detrusor leak point pressure, combined with renal function and urinary ultrasound results, as our evaluation indicators. Follow up evaluations will be conducted at 6 and 12 months after permanent implantation, and periodic comparisons will be made with baseline data to gain a more comprehensive understanding of the effectiveness and safety of sacral nerve regulation surgery.",[112,27,113],"Cystometry","Ultrasound","2024-08-11",{"date":116,"type":38},"2024-08-14",{"date":118,"type":38},"2023-12-01",{"date":120,"type":20},"2025-12-31",{"name":122,"class":45},"Qilu Hospital of Shandong University"]