Dataset Information

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.

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).

SUBMITTER: Xu L

PROVIDER: S-EPMC7409967 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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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.

Xu Lin L Fu Chenying C Zhang Qing Q Xiong Feng F Peng Lihong L Liang Zejun Z Chen Li L He Chengqi C Wei Quan Q

BMJ open 20200805 8

<h4>Introduction</h4>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 transcr ...[more]

PMID: 32759239

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Project description:BackgroundQuantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into pathophysiology of pelvic organ prolapse (POP). An innovative approach-vaginal tactile imaging-allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The Vaginal Tactile Imager (VTI) records high definition pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions.ObjectiveTo explore an extended set of 52 biomechanical parameters for differentiation and characterization of POP relative to normal pelvic floor conditions.Methods96 subjects with normal and POP conditions were included in the data analysis from multi-site observational, case-controlled studies; 42 subjects had normal pelvic floor conditions and 54 subjects had POP. The VTI, model 2S, was used with an analytical software package to calculate automatically 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The groups were equalized for subject age and parity.ResultsThe ranges, mean values, and standard deviations for all 52 VTI parameters were established. 33 of 52 parameters were identified as statistically sensitive (p < 0.05; t-test) to the POP development. Among these 33 parameters, 11 parameters show changes (decrease) in tissue elasticity, 8 parameters show deteriorations in pelvic support and 14 parameters show weakness in muscle functions for POP versus normal conditions.ConclusionsThe biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing POP versus normal conditions. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions under POP may be used in future research and practical applications.

Project description:BACKGROUND:Further progress in restoring a woman's health may be possible if a patient with a damaged pelvic floor could undergo medical imaging and biomechanical diagnostic tests. The results of such tests could contribute to the analysis of multiple treatment options and suggest the optimal one for that patient. AIM:To develop a new approach for the biomechanical characterization of vaginal conditions, muscles, and connective tissues in the female pelvic floor. METHODS:Vaginal tactile imaging (VTI) allows biomechanical assessment of the soft tissue along the entire length of the anterior, posterior, and lateral vaginal walls at rest, with manually applied deflection pressures and with muscle contraction, muscle relaxation, and Valsalva maneuver. VTI allows a large body of measurements to evaluate individual variations in tissue elasticity, support defects, as well as pelvic muscle function. Presuming that 1) the female pelvic floor organs are suspended by ligaments against which muscles contract to open or close the outlets and 2) damaged ligaments weaken the support and may reduce the force of muscle contraction, we made an attempt to characterize multiple pelvic floor structures from VTI data. RESULTS:All of the 138 women enrolled in the study were successfully examined with the VTI. The study subjects have had normal pelvic support or pelvic organ prolapse (stages I-IV). The average age of this group of subjects was 60±15 years. We transposed a set of 31 VTI parameters into a quantitative characterization of pelvic muscles and ligamentous structures. Interpretation of the acquired VTI data for normal pelvic floor support and prolapse conditions is proposed based on biomechanical assessment of the functional anatomy. CONCLUSION:Vaginal tactile imaging allows biomechanical characterization of female pelvic floor structures and tissues in vivo, which may help to optimize treatment of the diseased conditions such as prolapse, incontinence, atrophy, and some forms of pelvic pain.

Dataset Information

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.

Publications

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.

Similar Datasets

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