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Open Access 01-12-2022 | Stroke | Study protocol

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

Authors: Wei Jiang, Wen Tang, Yunling Song, Yali Feng, Yuesan Zhou, Lang Li, Botao Tan

Published in: Trials | Issue 1/2022

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.

Available only for authorised users

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Title: Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial
Authors: Wei Jiang
Wen Tang
Yunling Song
Yali Feng
Yuesan Zhou
Lang Li
Botao Tan
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Stroke
Repetitive Transcranial Magnetic Stimulation
Urinary Incontinence
Urinary Incontinence
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06535-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background and purpose

Methods and analysis

Ethics and dissemination

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background and purpose

Methods and analysis

Ethics and dissemination

Trial registration

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