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Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial Nerve Stimulation for Neurogenic Bladder in MS

Not Yet RecruitingNA

Sponsor: Sierra Varona SL

Conditions: Neurogenic Overactive Bladder, Multiple Sclerosis

Interventions: Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation, Repetitive Transcranial Magnetic Stimulation, Percutaneous Tibial Nerve Stimulation

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Active urinary tract infection at the time of selection.
* Individuals with a history of urological conditions other than overactive bladder secondary to multiple sclerosis.
* Contraindications for electrical stimulation:
* Presence of metal in the skull
* Intracardiac lines
* History of increased intracranial pressure
* Significant heart disease
* Pacemaker or implantable desfibrillator usage
* Use of implanted medication pumps
* Treatment with tricyclic antidepressants or neuroleptics
* Personal or family history of epilepsy
* Pregnant or breastfeeding women