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

NCT06581341 | Not Yet Recruiting

• 2 other identifiers: 00135465
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neurogenic Overactive Bladder; Multiple Sclerosis

Keywords

Múltiple Sclerosis; Neurogenic Overactive Bladder; Posterior Tibial Nerve Meuromodulation; Repetitive Transcranial Magnetic Stimulation.

Outcome Measures

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

  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 (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.

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

Group 1

EXPERIMENTAL

Combination of transcranial magnetic stimulation and percutaneous tibial nerve stimulation.

Device: Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation

Group 2

EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS):

Device: Repetitive Transcranial Magnetic Stimulation

Group 3

EXPERIMENTAL

Percutaneous tibial nerve stimulation.

Device: Percutaneous Tibial Nerve Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation DEVICE

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. 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.

Group 1

Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Group 2

Percutaneous Tibial Nerve Stimulation DEVICE

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.

Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sierra Varona SL: lead
• Universidad Complutense de Madrid: collaborator

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Related Links

• Guidelines. Uroweb - European Association of Urology. Retrieved September 5, 2023

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Elena Fernández, Physiotherapist

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ALBERTO SANCHEZ SIERRA, PhD

CONTACT

+34608801238; alberto.sanchez@uclm.es

Arturo Ladriñán Maestro, Msc

CONTACT

+34926295377; arturo.ladrinan@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: clínical Trials with 3 arms

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: September 3, 2024
• Study Start: October 1, 2024
• Primary Completion: January 27, 2025
• Study Completion: September 22, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08