Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial

Lin Xu; Chenying Fu; Qing Zhang; Feng Xiong; Lihong Peng; Zejun Liang; Li Chen; Chengqi He; Quan Wei

doi:10.1136/bmjopen-2019-034582

Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial

BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.

Authors

Lin Xu^#^{1

2}, Chenying Fu^#³, Qing Zhang^{1

2}, Feng Xiong^{1

2}, Lihong Peng^{1

2}, Zejun Liang^{1

2}, Li Chen^{1

2}, Chengqi He^{1

2}, Quan Wei^{4

2}

Affiliations

¹ Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.
² Key Laboratory of Rehabilitation Medicine in Sichuan Province, Chengdu, Sichuan, PR China.
³ State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.
⁴ Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China weiquan@scu.edu.cn.

^# Contributed equally.

Abstract

Introduction: Neurogenic bladder dysfunction is prevalent in female patients with spinal cord injury (SCI), and previous guidelines have recommended pelvic floor muscle training (PFMT) for first-line conservative treatment. However, the actual regimen of PFMT varies widely and the single treatment does not satisfy the need of some patients. Therefore, this study aims to provide a detailed rationale and methodology for comparing the effectiveness of PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS) as adjunct treatments for neurogenic bladder dysfunction.

Methods and analysis: This trial is a single-centre randomised controlled trial for female patients with urinary incontinence (UI) in phase of chronic SCI. Eligible participants will be randomised to one of four arms: (1) PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS. There will be 44 participants in each arm and all the subjects will undergo 20 treatment sessions, five times a week for 4 weeks. The outcomes will be evaluated at 4 weeks, 3 months and 6 months after randomisation. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.

Ethics and dissemination: The Clinical Research and Biomedical Ethics Committee of the West China Hospital, Sichuan University has approved this trial and the approval number is 2019-885. All participants will be provided written informed consent after verification of the eligibility criteria. The results of this study will be accessible in peer-reviewed publications and be presented at academic conferences.

Trial registration number: Chinese Clinical Trial Registry (ChiCTR1900026126).

Keywords: rehabilitation; urinary bladder, neurogenic; urinary incontinence.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Biofeedback, Psychology
China
Exercise Therapy
Female
Humans
Pelvic Floor
Quality of Life
Randomized Controlled Trials as Topic
Spinal Cord Injuries* / complications
Transcranial Magnetic Stimulation
Treatment Outcome
Urinary Bladder, Neurogenic* / etiology
Urinary Bladder, Neurogenic* / therapy
Urinary Incontinence, Stress*