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

Status unknownNot a drug-phase studyMS (type not specified)NCT06581341

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

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

What it measured

Main measures

  • Reduction in Frequency of Urinary Urgency 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..

    Bladder, bowel and sexual function

Other measures (5)

  • Frequency 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.

    Bladder, bowel and sexual function
  • Urinary Incontinence

    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.

    Bladder, bowel and sexual functionQuality of life (reported by participants)
  • Expanded Disability Status Scale (EDSS)

    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.

    Disability progression
  • The Multiple Sclerosis Quality of Life-54 (MSQoL-54) Questionnaire

    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.

    Quality of life (reported by participants)
  • The semi-open question to assess the impact of overactive bladder on daily 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.

    Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 to 65 · EDSS 0 to 7

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Oct 2024

    2. Main results due

      Jan 2025

    3. Finished

      Sept 2025

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