Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial
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
We could not find results for this trial
What it 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 functionUrinary 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 progressionThe 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
Background
Garcia Lopez FJ, Garcia-Merino A, Alcalde-Cabero E, de Pedro-Cuesta J. Incidence and prevalence of multiple sclerosis in Spain: a systematic review. Neurologia (Engl Ed). 2024 Oct;39(8):639-650. doi: 10.1016/j.nrleng.2022.02.004. Epub 2022 Nov 21.Background
Klineova S, Lublin FD. Clinical Course of Multiple Sclerosis. Cold Spring Harb Perspect Med. 2018 Sep 4;8(9):a028928. doi: 10.1101/cshperspect.a028928.Background
Pitt D, Lo CH, Gauthier SA, Hickman RA, Longbrake E, Airas LM, Mao-Draayer Y, Riley C, De Jager PL, Wesley S, Boster A, Topalli I, Bagnato F, Mansoor M, Stuve O, Kister I, Pelletier D, Stathopoulos P, Dutta R, Lincoln MR. Toward Precision Phenotyping of Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2022 Aug 30;9(6):e200025. doi: 10.1212/NXI.0000000000200025. Print 2022 Nov.Background
Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030.Background
Erden E, Ersoz M, Tiftik T, Erden E. The neurogenic bladder characteristics and treatment approaches in the patients with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103439. doi: 10.1016/j.msard.2021.103439. Epub 2021 Dec 3.Background
Hemmett L, Holmes J, Barnes M, Russell N. What drives quality of life in multiple sclerosis? QJM. 2004 Oct;97(10):671-6. doi: 10.1093/qjmed/hch105.Background
Aharony SM, Lam O, Corcos J. Treatment of lower urinary tract symptoms in multiple sclerosis patients: Review of the literature and current guidelines. Can Urol Assoc J. 2017 Mar-Apr;11(3-4):E110-E115. doi: 10.5489/cuaj.4059. Epub 2017 Mar 16.Background
Sousa-Fraguas MC, Lastra-Barreira D, Blanco-Diaz M. Peripheral neuromodulation in women with overactive bladder syndrome: a systematic review. Actas Urol Esp (Engl Ed). 2021 Apr;45(3):177-187. doi: 10.1016/j.acuro.2020.10.003. Epub 2021 Jan 19. English, Spanish.Background
Canbaz Kabay S, Kabay S, Mestan E, Cetiner M, Ayas S, Sevim M, Ozden H, Karaman HO. Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results. Neurourol Urodyn. 2017 Jan;36(1):104-110. doi: 10.1002/nau.22868. Epub 2015 Sep 9.Background
Martin-Garcia M, Crampton J. A single-blind, randomized controlled trial to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in Overactive Bladder symptoms in women responders to percutaneous tibial nerve stimulation (PTNS). Physiotherapy. 2019 Dec;105(4):469-475. doi: 10.1016/j.physio.2018.12.002. Epub 2018 Dec 18.
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History
Started
Oct 2024
Main results due
Jan 2025
Finished
Sept 2025