Protocol for a phase II, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injury suffering from neurogenic detrusor overactivity for amelioration of autonomic dysreflexia

BMJ Open, 2018 · DOI: 10.1136/bmjopen-2018-024084 · Published: September 28, 2018

Simple Explanation

This study aims to determine if fesoterodine, a drug used for overactive bladder, can help reduce the severity and frequency of autonomic dysreflexia (AD) episodes in individuals with spinal cord injury (SCI) who also have neurogenic detrusor overactivity (NDO). AD is a condition where blood pressure spikes dangerously due to a stimulus below the injury level. The study will involve monitoring participants' cardiovascular and cerebrovascular responses during bladder filling and daily life to see if fesoterodine can improve these responses and potentially protect cerebrovascular health and cognitive function. By treating NDO and therefore preventing peripheral afferent stimulation to the spinal cord, we could potentially decrease irritation of the spinal autonomic circuits that are responsible for triggering AD, ameliorate symptoms of this condition and consequently reduce chronic cardiovascular and cerebrovascular complications in this population.

Study Duration

12 weeks

Participants

Individuals with chronic traumatic SCI, at or above the level of spinal segment T6, with documented AD triggered by NDO

Evidence Level

Level II, Phase II, open-label exploratory, non-blinded, non-randomised, single-centre study

Key Findings

1
This study aims to assess the efficacy of fesoterodine in reducing AD episodes triggered by NDO in adults with SCI.
2
The primary outcome is a reduction of artificially induced (during UDS) and spontaneous (during daily life) episodes of AD.
3
The study will also evaluate secondary outcomes such as improvements in self-reported AD severity, bladder incontinence, cognitive function, and bowel function.

Research Summary

This phase II study investigates the efficacy of fesoterodine in improving neurogenic detrusor overactivity (NDO) and ameliorating autonomic dysreflexia (AD) in individuals with spinal cord injury (SCI). The study involves cardiovascular and cerebrovascular monitoring during urodynamics and daily life to assess the severity and frequency of AD episodes. The findings will be published in peer-reviewed journals and presented at scientific meetings, adhering to established protocol guidelines.

Practical Implications

Potential Treatment Option

Fesoterodine could be a potential treatment option to reduce chronic cardiovascular and cerebrovascular complications in individuals with SCI.

Improved Quality of Life

Treatment of NDO with fesoterodine may improve bladder function, reduce AD episodes, and enhance the overall well-being of individuals with SCI.

Reduced Healthcare Costs

By reducing the incidence and severity of AD, fesoterodine could potentially lower the frequency of hospitalisations related to AD, thereby reducing healthcare costs.

Study Limitations

1
The study results will be limited by the participant’s behavioural habits and lifestyle factors (which will not be controlled) such as water intake, alcohol and coffee consumption, exercise routine, work and availability of caregivers.
2
As this is a phase II, exploratory open-label study, we are not providing any sample size calculations.
3
The single-centre design might limit the generalizability of the findings.

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