Neurogenic Detrusor Overactivity

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of transcutaneous tibial nerve stimulation (TTNS) in managing neurogenic detrusor overactivity in spinal cord injury patients. 12 - 16 spinal cord injury patients with neurogenic detrusor overactivity will be recruited. The intervention includes administration of TTNS at the highest tolerated level for 20 minutes daily for 4 weeks, using a neuromodulation device -- Tensi+. Outcome measures including Urodynamic Study (UDS) will be retrieved or collected at baseline and collected after the 4 weeks of TTNS administration. Other outcome measures include Overactive Bladder Questionnaire Short Form (OAB-Q-SF), which will be administered before and after TTNS administration, subject's level of discomfort and any adverse events experienced by the subject will be recorded after each intervention session and a bladder diary will be recorded weekly for subjects not on indwelling urinary catheters. A TTNS satisfaction survey will also be performed at the end of the study.

The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC

The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes. Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home. In 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS. Outcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.