[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560760":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":42,"studyPopulation":31,"armGroups":43,"interventions":60,"overallOfficials":74,"centralContacts":79,"locations":31,"responsibleParty":89,"collaborators":91,"id":94,"slug":31,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":31,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":31,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":117,"whyStopped":31,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":31},{"fullName":5,"class":6},"Sierra Varona SL","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Reduction in Frequency of Urinary Urgency Episodes","Urgency urinary incontinence is marked by a sudden, intense urge to urinate, often leading to involuntary leakage. This clinical trial focuses on assessing both the presence and severity of urinary urgency in participants.It will be measured using a voiding diary. Participants will receive clear instructions on how to complete the diary, where they will record their daily voiding episodes","Participants will complete questionnaires at four time points: 2 weeks before the start of treatment, immediately at the end of treatment, and 4 and 24 weeks post-treatment..",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Frequency of Urination","The term \"frequency of urination\" is defined as the number of times a person urinates within a specified time period. The frequency of urination exhibited by a participant over the course of a day is a key indicator of overall hydration status.\n\nThe measurement of this variable is as follows: A bladder diary will be employed for the purpose of data collection. The participants will be provided with explicit instructions regarding the completion of the diary, which they will utilize to record their daily instances of urination.","Participants will complete questionnaires at four time points: 2 weeks before the start of treatment, immediately at the end of treatment, and 4 and 24 weeks post-treatment.t.",{"measure":19,"description":20,"timeFrame":21},"Urinary Incontinence","Involuntary micturation of urine, which may manifest as dribbling, minor incontinence episodes, or significant leakage.It will be measured using a validated questionnaire, the Overactive Bladder Symptom Score (OABSS), which assesses the frequency and intensity of urinary urgency, as well as its impact on the participants' quality of life","Participants will complete questionnaires at four time points: 2 weeks before the start of treatment, immediately at the end of treatment, and 4 and 24 weeks post-treatment.",{"measure":23,"description":24,"timeFrame":21},"Expanded Disability Status Scale (EDSS)","The assessment tool evaluates visual, motor, sensory, sphincteric, and cerebellar functions. The EDSS will be used to measure the effectiveness of a treatment in reducing disease progression and disability across these systems.",{"measure":26,"description":27,"timeFrame":21},"The Multiple Sclerosis Quality of Life-54 (MSQoL-54) Questionnaire","The 54-item questionnaire assesses multiple dimensions of quality of life, including physical function, emotional well-being, mental health, vitality, and social function. The domains deemed pertinent to this study encompass physical function, social function, and emotional well-being.",{"measure":29,"description":30,"timeFrame":21},"The semi-open question to assess the impact of overactive bladder on daily life.","Describe how overactive bladder symptoms affected your daily life and well-being in the past day. Include any specific instances where these symptoms significantly impacted your routine or activities.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"RANDOMIZED","PARALLEL","clínical Trials with 3 arms","TREATMENT",{"masking":38,"maskingDescription":39,"whoMasked":40},"SINGLE","This study employs a single-blind, randomized clinical trial design, with participants assigned to one of three groups: Group 1 receives repetitive transcranial magnetic stimulation (rTMS) combined with posterior tibial nerve percutaneous neuromodulation, Group 2 receives only rTMS, and Group 3 receives only posterior tibial nerve percutaneous neuromodulation. To prevent allocation bias, sealed, opaque, numbered envelopes containing color-coded cards (red for Group 1, green for Group 2, yellow for Group 3) will be used. These envelopes will be selected sequentially at the time of inclusion, ensuring that neither participants nor investigators can predict the assignments. The principal investigator will oversee randomization and administer the treatments, while the collaborating investigator, who is blinded to group assignments, will evaluate the participants. This methodology preserves the study's randomized integrity and ensures unbiased group assignments.",[41],"INVESTIGATOR","Multiple Sclerosis (MS) is a chronic, autoimmune, inflammatory, demyelinating, and degenerative neurological disease that affects the central nervous system. Symptoms vary widely depending on the areas involved and may include fatigue, blurred vision, speech disturbances, limb weakness, tremors, loss of sensation, vertigo, coordination difficulties, and bladder and bowel dysfunctions. Among these, lower urinary tract symptoms are particularly common and significantly impact the quality of life in MS patients.\n\nNeurogenic overactive bladder (NOAB) is the most prevalent urinary complaint in individuals with MS. Current therapeutic options for NOAB in MS include behavioral therapy, β-3 agonists, anticholinergic agents, posterior tibial nerve neuromodulation (PTNM), botulinum toxin injections, sacral root neurostimulation, and surgical interventions.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp. Similarly, posterior tibial nerve neuromodulation (PTNM) involves electrical stimulation of the spinal cord roots, mainly the S3 segment, to enhance bladder function.\n\nAlthough current literature suggests the potential efficacy of both neuromodulation techniques for NOAB, they are not yet widely recommended in global guidelines, largely due to the limited number of studies, many of which are case reports.\n\nThe increasing incidence of overactive bladder highlights the urgent need for effective therapeutic interventions. Non-invasive neuromodulation techniques offer promising avenues to enhance treatment outcomes and optimize existing protocols.\n\nThis study aims to compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa. The objective is to determine whether rTMS is superior, equivalent, or inferior to tibial nerve stimulation in treating this condition.\n\nThe hypothesis posits that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa, with the goal of determining whether rTMS is more effective, equally effective, or less effective than tibial nerve stimulation.\n\nSecondary objectives include:\n\nAssessing the efficacy of rTMS in reducing urinary symptoms associated with NOAB in MS patients.\n\nEvaluating the combined effects of transcranial magnetic stimulation and tibial nerve stimulation on urinary symptoms.\n\nExamining the short- and medium-term effects of the treatments on urinary symptoms.\n\nAnalyzing the impact of the treatments on the quality of life in MS patients, using the Multiple Sclerosis Quality of Life-54 Questionnaire (MsQoL-54).\n\nEvaluating the applicability of the treatment protocols and analyzing clinical data for future neuromodulation research.\n\nSafety and Adverse Events Monitoring\n\nThe study will adhere to current regulatory frameworks governing TMS and PTNS protocols to ensure safety and monitor adverse events. TMS is considered a well-tolerated procedure with minimal adverse effects, even in long-term studies. Commonly observed side effects, which typically resolve within a few days, include headaches, paresthesia, limb pain, restless legs syndrome, increased bladder spasticity, and nonspecific discomfort.\n\nA review of the literature indicates no significant complications associated with percutaneous tibial nerve stimulation (PTNS). However, potential adverse events include skin irritation, increased pain at the stimulation site, rare skin lesions, allergic reactions, and general discomfort.\n\nAny adverse events will be reported to the Ethics Committee and managed according to current safety standards, with monthly documentation. Serious adverse events will be reported immediately.\n\nSafety Protocol\n\nTo mitigate potential risks associated with TMS and PTNS, the following safety measures will be implemented:\n\nProper selection of stimulation intensity and frequency. Precise location of stimulation. Application of aseptic and antiseptic techniques. Monitoring of vital signs (heart rate, blood pressure, oxygen saturation) during and after procedures to detect cardiovascular complications.\n\nInformed consent will be obtained from participants, including comprehensive information about potential risks and the voluntary nature of participation. All personnel involved will be adequately trained in administering the techniques and identifying potential safety issues. All relevant ethical and legal regulations will be observed.\n\nSample Recruitment\n\nParticipants will be recruited through the Rehabilitation Physician, who will inform potential participants about the study during consultations, providing them with a Patient Information Sheet and Informed Consent Form.\n\nStudy Design\n\nThis study employs a single-blind, randomized clinical trial design. Participants will be randomly assigned to one of three groups:\n\nGroup A: rTMS combined with PTNS. Group B: rTMS alone. Group C: PTNS alone. Sealed, opaque, and numbered envelopes will be used to ensure unbiased group assignments. The anticipated start date is one month after receiving Ethics Committee approval.\n\nTranscranial Magnetic Stimulation (TMS) Protocol\n\nThe study will use high-frequency TMS at 10 Hz, with a total of 2,000 pulses per session. The treatment duration is 30 minutes, with 12 sessions conducted over 4 weeks (3 sessions per week).\n\nPercutaneous Tibial Nerve Stimulation (PTNS) Protocol\n\nPTNS will involve needle placement 5-6 cm from the medial malleolus, with a pulse duration of 200 µs and a frequency of 20 Hz. Each session will last 30 minutes, with 12 sessions conducted over 4 weeks (3 sessions per week).\n\nRandomization and Blinding\n\nThe principal investigator will conduct randomization, while the collaborating investigator will remain unaware of group assignments. The principal investigator will administer the treatments, maintaining single-blind conditions.",[44,50,55],{"label":45,"type":46,"description":47,"interventionNames":48},"Group 1","EXPERIMENTAL","Combination of transcranial magnetic stimulation and percutaneous tibial nerve stimulation.",[49],"Device: Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation",{"label":51,"type":46,"description":52,"interventionNames":53},"Group 2","Repetitive Transcranial Magnetic Stimulation (rTMS):",[54],"Device: Repetitive Transcranial Magnetic Stimulation",{"label":56,"type":46,"description":57,"interventionNames":58},"Group 3","Percutaneous tibial nerve stimulation.",[59],"Device: Percutaneous Tibial Nerve Stimulation",[61,66,70],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":31},"DEVICE","Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation","Repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure that uses a magnetic coil placed on the scalp to deliver magnetic pulses to the motor cortex, with the aim of improving bladder function by modulating brain activity associated with bladder control. The MagRex magnetic stimulator with an 8-shaped coil will be used at a frequency of 10 Hz, delivering 2000 pulses per session (6 seconds on, 24 seconds rest protocol) at 90% of the motor threshold. The treatment will consist of 3 sessions per week over a period of 4 weeks.\n\nPercutaneous Tibial Nerve Stimulation (PTNM): PTNM involves the use of electrical stimulation applied to the posterior tibial nerve to enhance bladder function by modulating neural pathways. A needle will be placed 5-6 cm proximal to the tibial malleolus, with the following parameters: 200 μs pulse duration, 20 Hz frequency, 30 minutes per session, 3 times per week for 12 weeks. The Neurotrac Pelvitone device will be used.",[45],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":31},"Repetitive Transcranial Magnetic Stimulation","Repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure that uses a magnetic coil placed on the scalp to deliver magnetic pulses to the motor cortex, with the aim of improving bladder function by modulating brain activity associated with bladder control. The MagRex magnetic stimulator with an 8-shaped coil will be used at a frequency of 10 Hz, delivering 2000 pulses per session (6 seconds on, 24 seconds rest protocol) at 90% of the motor threshold. The treatment will consist of 3 sessions per week over a period of 4 weeks.",[51],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":31},"Percutaneous Tibial Nerve Stimulation","Percutaneous Tibial Nerve Stimulation (PTNM): PTNM involves the use of electrical stimulation applied to the posterior tibial nerve to enhance bladder function by modulating neural pathways. A needle will be placed 5-6 cm proximal to the tibial malleolus, with the following parameters: 200 μs pulse duration, 20 Hz frequency, 30 minutes per session, 3 times per week for 12 weeks. The Neurotrac Pelvitone device will be used.",[56],[75],{"name":76,"affiliation":77,"role":78},"Elena Fernández, Physiotherapist","Fundación de Investigación Biomédica - Hospital Universitario de La Princesa","PRINCIPAL_INVESTIGATOR",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":31,"email":84},"ALBERTO SANCHEZ SIERRA, PhD","CONTACT","+34608801238","alberto.sanchez@uclm.es",{"name":86,"role":82,"phone":87,"phoneExt":31,"email":88},"Arturo Ladriñán Maestro, Msc","+34926295377","arturo.ladrinan@uclm.es",{"type":90,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[92],{"name":93,"class":6},"Universidad Complutense de Madrid","100560760",false,"NCT06581341","Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial Nerve Stimulation for Neurogenic Bladder in MS","Improvement of Pelvic Floor Function Using Repetitive Transcranial Magnetic Stimulation and Posterior Tibial Nerve Stimulation in Treating Neurogenic Overactive Bladder in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n* Volunteer Adults (Age 18-65)\n* Diagnosis of Multiple Sclerosis\n* Expanded Disability Status Scale (EDSS) 0-7\n* Diagnosis of overactive bladder disfunction secondary to multiple sclerosis\n\nExclusion Criteria:\n\n* Active urinary tract infection at the time of selection.\n* Individuals with a history of urological conditions other than overactive bladder secondary to multiple sclerosis.\n* Contraindications for electrical stimulation:\n* Presence of metal in the skull\n* Intracardiac lines\n* History of increased intracranial pressure\n* Significant heart disease\n* Pacemaker or implantable desfibrillator usage\n* Use of implanted medication pumps\n* Treatment with tricyclic antidepressants or neuroleptics\n* Personal or family history of epilepsy\n* Pregnant or breastfeeding women","ALL","18 Years","65 Years",{"count":104,"type":105},60,"ESTIMATED","INTERVENTIONAL",[108],"NA","Multiple Sclerosis (MS) is a chronic, autoimmune, inflammatory, and degenerative neurological disorder that affects the central nervous system. Symptoms vary widely depending on the areas impacted and may include fatigue, vision issues, speech difficulties, tremors, limb weakness, loss of sensation, vertigo, coordination problems, and bladder and bowel dysfunction. Among these, lower urinary tract symptoms are particularly common and significantly impact the quality of life for MS patients.\n\nNeurogenic overactive bladder (NOAB) is a prevalent urinary issue in individuals with MS. Treatment options for NOAB include behavioral therapy, β-3 agonists, anticholinergic agents, posterior tibial nerve neuromodulation (PTNM), botulinum toxin injections, sacral root neurostimulation, and surgical interventions.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp. In contrast, posterior tibial nerve neuromodulation (PTNM) involves electrical stimulation of the spinal cord roots, primarily the S3 segment, to enhance bladder function.\n\nDespite promising evidence, rTMS and PTNM are not yet widely recommended in global guidelines due to the limited number of studies, many of which are case reports. The growing prevalence of overactive bladder underscores the need for effective, non-invasive treatments to improve management and optimize current protocols.\n\nThis study aims to evaluate and compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa. The primary objective is to determine whether rTMS is superior, equivalent, or inferior to tibial nerve stimulation in treating NOAB.\n\nThe study's hypothesis is that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa, with a focus on assessing whether rTMS offers superior, equivalent, or inferior outcomes compared to tibial nerve stimulation. This investigation seeks to provide valuable insights into the effectiveness of these treatment modalities.",[111,112],"Neurogenic Overactive Bladder","Multiple Sclerosis",[114,111,115,116],"Múltiple Sclerosis","Posterior Tibial Nerve Meuromodulation","Repetitive Transcranial Magnetic Stimulation.","NOT_YET_RECRUITING","2024-08-27",{"date":120,"type":121},"2024-09-03","ACTUAL",{"date":123,"type":105},"2024-10-01",{"date":125,"type":105},"2025-09-22",{"name":5,"class":6}]