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

Trials, 2022 · DOI: https://doi.org/10.1186/s13063-022-06535-y · Published: July 11, 2022

Simple Explanation

This study aims to investigate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in treating urinary incontinence (UI) after stroke. Patients will receive either low-frequency rTMS or a sham treatment. The study will assess changes in bladder function using urodynamic tests, along with questionnaires to evaluate the severity of UI symptoms and the impact on daily life. The researchers hope to provide evidence for the rehabilitation management of stroke patients with bladder dysfunction using rTMS.

Study Duration

4 weeks intervention period, 3 months follow-up

Participants

140 stroke patients with urinary incontinence

Evidence Level

Level 1: Single-centre, randomized double-blind, placebo-controlled superiority trial

Key Findings

1
The primary outcome measure is the change in urodynamic test results at baseline versus 4 weeks after the rTMS intervention.
2
Secondary outcome measures include the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF).
3
Pelvic floor muscle function will also be assessed as a secondary outcome using electromyography activity.

Research Summary

This study protocol outlines a randomized controlled trial to evaluate the efficacy and safety of low-frequency rTMS on the contralesional primary motor cortex (M1) for treating poststroke urinary incontinence (PSI). The trial will involve 140 participants randomized into rTMS and sham rTMS groups, receiving 20 treatment sessions over 4 weeks, with urodynamic tests as the primary outcome measure. The results of this RCT will provide scientific evidence for the rehabilitation management of stroke patients with bladder dysfunction.

Practical Implications

Clinical Practice

Provides insights into managing poststroke urinary incontinence, a common complication affecting a significant percentage of stroke patients.

Therapeutic Intervention

Evaluates the potential of rTMS as a non-invasive brain stimulation method for improving bladder function and relieving incontinence symptoms.

Future Research

Offers a foundation for further investigation into the use of rTMS and other therapies for neurogenic bladder dysfunction.

Study Limitations

1
Single-center study
2
Physicians and therapists administering the rTMS protocol cannot be blinded
3
Potential adverse reactions and the physiological state of the stroke survivors, anticipate a 15~20% dropout rate

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