Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial

Abstract

Background and purpose: Poststroke urinary incontinence (PSI) is prevalent in stroke survivors, and high-quality evidence is required to guide clinical practice. Previous studies have demonstrated the curative effect of repetitive transcranial magnetic stimulation (rTMS) for urinary incontinence in individuals with multiple sclerosis (MS), Parkinson's disease (PD), and spinal cord injury (SCI). Here, we describe the protocol for a randomized controlled trial to evaluate the efficacy and safety of low-frequency rTMS on the contralesional primary motor cortex (M1) for the treatment of PSI.

Methods and analysis: In this single-centre randomized controlled trial for poststroke urinary incontinence, a total of 140 eligible patients will be randomly allocated into two groups. The rTMS group (n = 70) will receive low-frequency rTMS at the M1 along with routine medical care, while the control group will receive sham rTMS along with routine medical care. All participants will undergo 20 treatment sessions, five times a week for 4 weeks. The primary outcome measures will be the changes in the urodynamic test at baseline versus 4 weeks after intervention. The secondary outcomes include the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), Overactive Bladder Symptom Score (OABSS), and pelvic floor muscle function.

Ethics and dissemination: The Institutional Review Board and Hospital Research Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University approved this trial, and the approval number is No. 2020-153. All methods will be carried out in accordance with the principles of the Declaration of Helsinki and relevant ethical guidelines covering informed consent, confidentiality, and data storage. After the study had been thoroughly described to the participants by a physician, all participants will provide written informed consent indicating their willingness to participate. The results will be disseminated to most of the population, including participants, researchers, healthcare providers, and sponsors.

Trial registration: URL: https://www.chictr.org.cn ; Unique identifier: ChiCTR2100042688. Date of Registration: 2021-01-26.

Keywords: Bladder; Clinical trial; Stroke; Urinary incontinence; rTMS.

Fig. 1

Proposed participant flow

Fig. 2

Locations of the hotspots for rTMS. This is a left hemiplegia patient with an ischaemic stroke on the right side of the cortex. Black dots with red circles show the hotspot. The patient will sit on the chair when they accept the intervention