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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Reduction in Frequency of Urinary Urgency Episodes
研究概览
简要总结
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.
详细描述
Multiple Sclerosis (MS) is a chronic, autoimmune, inflammatory, demyelinating, and degenerative neurological disease that affects the central nervous system. Symptoms vary widely depending on the areas involved and may include fatigue, blurred vision, speech disturbances, limb weakness, tremors, loss of sensation, vertigo, coordination difficulties, and bladder and bowel dysfunctions. Among these, lower urinary tract symptoms are particularly common and significantly impact the quality of life in MS patients.
Neurogenic overactive bladder (NOAB) is the most prevalent urinary complaint in individuals with MS. Current therapeutic options for NOAB in MS 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. Similarly, posterior tibial nerve neuromodulation (PTNM) involves electrical stimulation of the spinal cord roots, mainly the S3 segment, to enhance bladder function.
Although current literature suggests the potential efficacy of both neuromodulation techniques for NOAB, they are not yet widely recommended in global guidelines, largely due to the limited number of studies, many of which are case reports.
The increasing incidence of overactive bladder highlights the urgent need for effective therapeutic interventions. Non-invasive neuromodulation techniques offer promising avenues to enhance treatment outcomes and optimize existing protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
Combination of transcranial magnetic stimulation and percutaneous tibial nerve stimulation.
干预措施: Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation (Device)
Group 2
Repetitive Transcranial Magnetic Stimulation (rTMS):
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Group 3
Percutaneous tibial nerve stimulation.
干预措施: Percutaneous Tibial Nerve Stimulation (Device)
结局指标
主要结局
Reduction in Frequency of Urinary Urgency Episodes
时间窗: 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..
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
次要结局
- 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.)
- 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.)
- 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 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.)