Breakthrough Clinical Results
EG 427 announced positive initial results from a clinical trial of EG110A, a novel DNA therapy for neurogenic bladder. The study showed an over 88% reduction in urinary incontinence episodes in patients with spinal cord injury treated with the lowest dose of EG110A at 12 weeks. EG110A also demonstrated a good safety profile. EG110A is a non-replicating HSV-1 vector designed to selectively silence the signals of type C sensory neurons responsible for bladder muscle overactivity. The Phase 1b/2a study is enrolling adult participants with NDO following SCI.
Key Highlights
- EG110A showed over 88% reduction in urinary incontinence episodes in neurogenic bladder patients.
- EG110A demonstrated a good safety profile.
- EG110A is the first DNA medicine to selectively target a specific subtype of sensory neurons at the local level.
- Results validate EG 427’s proprietary HERMES nrHSV-1 technology platform.
Incidence and Prevalence
Latest Estimates of Incidence and Prevalence of Neurogenic Bladder Globally
The available research on neurogenic bladder provides limited global epidemiological data, with most studies focusing on specific populations rather than worldwide prevalence or incidence rates.
Pediatric Population Data
Functional bladder disorders in children affect approximately 5-15% of the pediatric population (2008). Unstable bladder, the most common pattern of urinary dysfunction in childhood, occurs in up to 57% of symptomatic children aged 3 to 14 years (2008). By age 4, most children have developed an adult pattern of urinary control.
The most common etiology of neurogenic bladder dysfunction (NBD) in children is abnormal development of the spinal column (2023). Neuro-spinal dysraphism was identified as the leading cause in 88.1% of patients in a study of 117 children with neuropathic bladder (2023).
A 2023 study from Turkey examining 117 patients with neuropathic bladder found that 62.4% were female and 37.6% were male, with a mean age of 6.7 ± 4.9 years. Similarly, a 2015 study of 33 patients with neurogenic bladder dysfunction aged three days to four years (mean 6.8 months) reported 61% males and 39% females.
Underlying Conditions
Neurogenic bladder/neurogenic lower urinary tract dysfunction (NB/NLUTD) can result from numerous nervous system abnormalities, including stroke, Alzheimer's and Parkinson's diseases, traumatic spinal cord injury, spinal cord tumors, congenital spina bifida, and diabetes (2016).
In a 2015 study, the most common associated anomaly with neurogenic bladder was meningomyelocele. A 2019 study of acute transverse myelitis patients found that 86.1% had neurogenic overactive detrusor with or without sphincter dyssynergia, and 83.7% reported increased frequency and urgency of urine, with 26 patients experiencing at least one episode of urge incontinence.
Recent Clinical Studies
A 2020 study reviewed data from 1104 patients with a mean NLUTD duration of 20.3±11.6 years, but did not provide population-level prevalence or incidence rates. Another 2020 study examined 412 patients who attended yearly check-ups at the Spinalis SCI clinic, with a 2021 study noting that nearly half of these patients reported ≥1 urinary tract infection during the preceding year.
The most recent research from 2024 acknowledges that neurogenic bladder dysfunction "stands as the most prevalent and incapacitating pelvic floor disorder amidst patients afflicted with specific upper motor neuron syndromes, including multiple sclerosis, stroke, and spinal cord injury," but does not provide specific global prevalence rates.
Despite worldwide strategies for prevention of neural tube defects, there are still spina bifida patients born every year with a neuropathic bladder at risk of long-term renal damage (2023).
Key Unmet Needs and Target Populations for Neurogenic Bladder
Unmet Needs
Recent publications highlight several unmet needs in the management of neurogenic bladder. A significant concern is the impact on quality of life, with different bladder management strategies showing varying levels of patient satisfaction. There is a lack of standardization in assessment tools, as quality of life is evaluated using a wide variety of validated and non-validated questionnaires.
For patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), there is a significant unmet need for bladder preserving therapy, as current options tend to postpone radical cystectomy rather than provide long-term disease control. The worldwide shortage of BCG further complicates treatment, necessitating policies that prioritize drug use and utilize alternative strategies.
Despite positive responses to treatments like gabapentin for neurogenic overactive bladder (NOAB), limitations in dosages and study durations hinder definitive endorsement. There is a need for high-quality randomized controlled trials comparing gabapentin with other treatments and exploring factors related to non-responsiveness.
Target Populations
Several specific populations are being targeted in recent research:
- Patients with spinal cord injury (88% of 3002 patients in a 2022 systematic review)
- Individuals with myelomeningocele (MMC), the majority of whom experience neurogenic bladder
- Patients with Parkinsonian disorders (PD) experiencing lower urinary tract symptoms (LUTS)
- Those with neural tube defects (pediatric patients)
- Individuals with multiple sclerosis
- Patients with radiation cystitis who develop neurogenic bladder symptoms
Emerging Treatment Approaches
Recent publications highlight several treatment approaches:
- Self-intermittent catheterization shows better outcomes for quality of life compared to other methods
- Hydrophilic-coated intermittent catheters (HCICs) generally demonstrate better outcomes than non-hydrophilic catheters
- Electrical neurostimulation and neuromodulation result in 30% to 50% clinical success
- Botulinum toxin injections, particularly for pediatric populations, with a cohort of 630 patients (median age 9.7 years) showing overall efficacy and safety
- Tibial neurostimulation showed better results than sacral neurostimulation for urge incontinence
- Peripheral electrical nerve stimulation demonstrated significant improvements in urodynamic outcomes
- Gabapentin as a less invasive option for neurogenic overactive bladder
The optimal approach appears to be multidisciplinary, involving urologists, neurologists, gynecologists, and physical medicine and rehabilitation physicians, with an emphasis on early rehabilitation programs.
Recent Studies
Recent Studies for Neurogenic Bladder
Based on a thorough review of the available information, I cannot provide specific details about recent studies for neurogenic bladder, including study names, interventions, or safety and efficacy outcomes. The information needed to address this query comprehensively is not available in the reference materials.
Neurogenic bladder is an important medical condition that affects bladder function due to neurological disorders. Research in this area typically examines various interventions including medications, neuromodulation techniques, catheterization protocols, and surgical approaches. Recent clinical studies would normally evaluate these interventions based on urodynamic parameters, quality of life measures, continence rates, and adverse events.
For the most current and accurate information about recent neurogenic bladder studies, consulting specialized medical databases such as PubMed, ClinicalTrials.gov, or journals focused on urology and neurourology would be recommended.