Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial Nerve Stimulation for Neurogenic Bladder in MS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSierra Varona SL
About this trial
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.
Neurogenic 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.
Repetitive 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.
Despite 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.
This 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.
The 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Volunteer Adults (Age 18-65)
Diagnosis of Multiple Sclerosis
Expanded Disability Status Scale (EDSS) 0-7
Diagnosis of overactive bladder disfunction secondary to multiple sclerosis
Disqualifiers
Active urinary tract infection at the time of selection.
Individuals with a history of urological conditions other than overactive bladder secondary to multiple sclerosis.
Presence of metal in the skull
Intracardiac lines
Trial design
Design model
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation
DeviceRepetitive 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. 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.
Repetitive Transcranial Magnetic Stimulation
DeviceRepetitive 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.
Percutaneous Tibial Nerve Stimulation
DevicePercutaneous 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
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..Secondary outcomes
1
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. The 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.
Time frame
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.2
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
Time frame
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.3
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.
Time frame
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.4
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.
Time frame
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sierra Varona SL
Lead sponsor
Universidad Complutense de Madrid
Collaborator
Source ClinicalTrials.gov
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