Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial Nerve Stimulation for Neurogenic Bladder in MS
NCT Number: NCT06581341
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neurogenic Overactive Bladder|Multiple Sclerosis
Interventions: DEVICE: Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation|DEVICE: Repetitive Transcranial Magnetic Stimulation|DEVICE: Percutaneous Tibial Nerve Stimulation
Sponsor: Sierra Varona SL
Collaborators: Universidad Complutense de Madrid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-09-22

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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, 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, 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), 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., 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, 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., 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., Describe how overactive bladder symptoms affected your daily life and well-being in the past day. Include any specific instances where these symptoms significantly impacted your routine or activities., 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.