Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury.

BACKGROUND: Neurogenic bladder (NGB) dysfunction after spinal cord injury (SCI) is generally irreversible. Preliminary animal and human studies have suggested that initiation of sacral neuromodulation (SNM) immediately following SCI can prevent neurogenic detrusor overactivity and preserve bladder capacity and compliance. We designed a multicenter randomized clinical trial to evaluate the effectiveness of early SNM after acute SCI. METHODS/DESIGN: The scientific protocol comprises a multi-site, randomized, non-blinded clinical trial. Sixty acute, acquired SCI patients (30 per arm) will be randomized within 12 weeks of injury. All participants will receive standard care for NGB including anticholinergic medications and usual bladder management strategies. Those randomized to intervention will undergo surgical implantation of the Medtronic PrimeAdvanced Surescan 97,702 Neurostimulator with bilateral tined leads along the S3 nerve root in a single-stage procedure. All patients will undergo fluoroscopic urodynamic testing at study enrollment, 3 months, and 1-year post randomization. The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year. After accounting for a 15% loss to follow-up, we expect 25 evaluable patients per arm (50 total), which will allow detection of a 38% treatment effect. This corresponds to an 84 mL difference in bladder capacity (80% power at a 5% significance level). Additional parameters will be assessed every 3 months with validated SCI-Quality of Life questionnaires and 3-day voiding diaries with pad-weight testing. Quantified secondary outcomes include: patient reported QoL, number of daily catheterizations, incontinence episodes, average catheterization volume, detrusor compliance, presence of urodynamic detrusor overactivity and important clinical outcomes including: hospitalizations, number of symptomatic urinary tract infections, need for further interventions, and bowel and erectile function. DISCUSSION: This research protocol is multi-centered, drawing participants from large referral centers for SCI and has the potential to increase options for bladder management after SCI and add to our knowledge about neuroplasticity in the acute SCI patient. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03083366 1/27/2017.

Short-term outcomes of Chait Trapdoor for antegrade continence enema in adults.

OBJECTIVE: To examine our short-term experience of antegrade continence enema (ACE) delivered via a Chait Trapdoor (Cook Medical, Bloomington, IN) in adults with intractable neurogenic bowel. METHODS: We performed a retrospective review at the Universities of Utah and Minnesota of 15 patients with Chait Trapdoor placed for the purpose of ACE from 2011 to 2013. Our primary outcome was continued utilization of the Chait Trapdoor. Secondary outcomes included volume of ACE used and time to produce a bowel movement. RESULTS: All patients had neurogenic bowel refractory to conventional bowel regimen. Mean follow-up was 6 months (range, 1-17 months). Thirteen patients had the Chait Trapdoor placed in the splenic flexure and 2 had it placed in the cecum. Of the 15 patients, 12 (80%) were still using the Chait Trapdoor at last follow-up. A median of 425 mL (range, 120-1000 mL) of fluid was used to produce a bowel movement in 5-120 minutes. Two patients developed postoperative wound infections, requiring return to the operating room (Clavien IIIb). Long-term complications included 5 patients with a dislodged tube requiring replacement by interventional radiology and 2 patients with local cellulitis. Two patients had the Chait Trapdoor moved to a new location to improve efficacy. CONCLUSION: Although the revision, removal, and complication rates were high, 80% of the patients were satisfied with the function and continued to use the Chait Trapdoor. The volume of irrigation required for ACE and the time it takes to produce a bowel movement vary significantly between patients.