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
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 do...
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BMJ Publishing Group
2020-08-01
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| Series: | BMJ Open |
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| author | Qing Zhang Li Chen Chengqi He Feng Xiong Lin Xu Chenying Fu Lihong Peng Zejun Liang Quan Wei |
| author_facet | Qing Zhang Li Chen Chengqi He Feng Xiong Lin Xu Chenying Fu Lihong Peng Zejun Liang Quan Wei |
| author_sort | Qing Zhang |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-25e8c8e6ea844d13b6c519534fdbbea5 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-25e8c8e6ea844d13b6c519534fdbbea52024-12-02T02:25:11ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2019-034582Efficacy 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 trialQing Zhang0Li Chen1Chengqi He2Feng Xiong3Lin Xu4Chenying Fu5Lihong Peng6Zejun Liang7Quan Wei8Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing, ChinaDivision of Growth, Development and Mental health of Children and Adolescence, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of ChinaDepartment of Rehabilitation Medicine Center, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaDepartment of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR ChinaOrthopedics, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, ChinaState Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, PR ChinaDepartment of Rehabilitation Medicine, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR ChinaDepartment of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR ChinaIntroduction 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).https://bmjopen.bmj.com/content/10/8/e034582.full |
| spellingShingle | Qing Zhang Li Chen Chengqi He Feng Xiong Lin Xu Chenying Fu Lihong Peng Zejun Liang Quan Wei 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/8/e034582.full |
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