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 · DOI: 10.1136/bmjopen-2019-034582 · Published: July 1, 2020

Simple Explanation

This study investigates treatments for neurogenic bladder dysfunction in women with spinal cord injury (SCI), a common issue affecting over half of this population. Current treatments like pelvic floor muscle training (PFMT) show varied effectiveness, prompting the exploration of additional therapies. The trial compares PFMT alone with PFMT combined with biofeedback, repetitive transcranial magnetic stimulation (rTMS), or both, to find more effective methods for managing this condition. The aim is to identify a standardized treatment plan to improve bladder function and quality of life for these patients. Participants will undergo 20 treatment sessions over 4 weeks, with evaluations at 4 weeks, 3 months, and 6 months. This research aims to fill gaps in current treatment approaches and provide evidence for better care strategies.

Study Duration

6 months

Participants

176 female patients with urinary incontinence (UI) in phase of chronic SCI

Evidence Level

Level 1: Single-centre randomised controlled trial

Key Findings

1
The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
2
Secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
3
This study aims to investigate the effectiveness and safety of PFMT, biofeedback and rTMS as adjunct treatments for neurogenic bladder dysfunction.

Research Summary

This randomised controlled trial aims to evaluate the efficacy and safety of pelvic floor muscle training (PFMT), biofeedback, and repetitive transcranial magnetic stimulation (rTMS) as adjunct treatments for female neurogenic bladder dysfunction following spinal cord injury (SCI). The study will compare four arms: PFMT alone, PFMT with biofeedback, PFMT with rTMS, and PFMT with both biofeedback and rTMS, with outcomes assessed at 4 weeks, 3 months, and 6 months post-randomisation. The trial seeks to determine a standardised regimen incorporating PFMT with other conservative treatments to improve bladder function and quality of life for women with neurogenic bladder dysfunction.

Practical Implications

Improved Treatment Protocols

The study could lead to more effective, standardized treatment protocols for neurogenic bladder dysfunction in women with SCI.

Enhanced Quality of Life

Successful outcomes could significantly improve the quality of life for affected individuals by reducing urinary incontinence and associated issues.

Clinical Practice Guidelines

The findings may influence clinical practice guidelines, promoting the adoption of combined therapies like PFMT with rTMS or biofeedback.

Study Limitations

1
Participant blinding and practitioner blinding cannot be achieved since sham biofeedback and rTMS procedures will not be applied in this trial.
2
Blinding of the assessor may be incomplete because the primary outcome, along with most outcomes of interest, is self-reported.
3
The participants might be heterogeneous due to the broad age range of the inclusion criteria, the difference between the types of neurogenic bladder dysfunction and the possibility of comorbidities with other medical conditions.

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