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

Qualifiers

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

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation
  • Repetitive Transcranial Magnetic Stimulation
  • Percutaneous Tibial Nerve Stimulation

Treatment groups

60 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Sierra Varona SL

Lead sponsor

Universidad Complutense de Madrid

Collaborator