Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.

OBJECTIVE: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation. METHODS: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline. RESULTS: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. CONCLUSIONS: The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Reducing resource utilization for patients with uncomplicated appendicitis through use of same-day discharge and elimination of postoperative antibiotics.

BACKGROUND: There is controversy over certain aspects of post-appendectomy care for children with uncomplicated appendicitis. Some institutions have embraced the practice of same-day discharge after appendectomy, while others are hesitant due to concerns about increased readmissions or emergency department (ED) visits. Similarly, some surgeons have transitioned to treating gangrenous appendicitis with a single perioperative dose, while others are concerned about increased risk of infection in this population. METHODS: We developed a pathway for the management of patients undergoing appendectomy for uncomplicated acute appendicitis which included same-day discharge and elimination of postoperative antibiotics for patients with gangrenous appendicitis. We compared outcomes for children treated at our institution before and after implementation of the protocol. RESULTS: We identified 575 patients undergoing appendectomy for uncomplicated appendicitis (307 pre- and 268 post-protocol). We observed a significant decrease in postoperative length-of stay (10.6 to 2.6 h, p < 0.0001). There were no increases in postoperative complications, such as superficial (2.6% vs 1.1%, p = 0.19) or organ-space surgical-site infection (1.6% vs 0.4%, p = 0.14), percutaneous drain placement (1.3% vs 0%, p = 0.06), postoperative ED visits (5.5% vs 5.2%, p = 0.87) or readmission (3.3% vs 1.5%, p = 0.17). CONCLUSIONS: These findings suggest that incorporating same-day discharge for simple appendicitis and eliminating postoperative antibiotics for children with gangrenous appendicitis does not increase complication rates. Implementation of similar pathways across institutions has the potential to significantly reduce resource utilization for children undergoing appendectomy for uncomplicated appendicitis. TYPE OF STUDY: Retrospective comparative study. LEVEL OF EVIDENCE: Level III.

The safety and efficacy of using negative pressure incisional wound VACs in pediatric and neonatal patients.

BACKGROUND: Surgical site infection (SSI) rates are an important surgical quality metric. Decreased SSI rates have been demonstrated using negative pressure incisional wound vac device (NPIWV) dressings in adults but have not been studied in children. MATERIALS AND METHODS: A retrospective review of patients treated with NPIWV at our institution between February 2016 and February 2018 was performed. NPIWV dressings were applied by previously described techniques. Using the same CPT codes from our study patients, we queried the National Surgical Quality Improvement Program-Pediatric (NSQIP-P) data between January 2014 and January 2016 to identify preimplementation controls (PIC). NPIWV patients were compared to historical controls to assess safety and efficacy of SSI prevention. RESULTS: There were 32 patients managed with NPIWV, and 65 patients in the PIC group. There were no NPIWV-associated complications. There was a trend toward reduced incidence of SSI in NPIWV patients, with 1 SSI in 32 cases (3.1%) versus 7 SSIs in the 65 historical control patients (10.8%) (p = 0.22). CONCLUSIONS: Our study shows that NPIWV dressings can be used safely in pediatric and neonatal patients undergoing surgery, with a trend toward decreased SSI rates. These findings should be confirmed in a larger, prospective trial. TYPE OF STUDY: Retrospective comparative study. LEVEL OF EVIDENCE: Level III.

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence.

PURPOSE: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence. MATERIALS AND METHODS: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values. RESULTS: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics. CONCLUSIONS: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.

Chronic suprapubic catheterization in the management of patients with spinal cord injuries: analysis of upper and lower urinary tract complications.

OBJECTIVE: To assess whether chronic suprapubic catheterization (SPC) in patients with spinal cord injury (SCI) is associated with a higher incidence of significant urinary tract complications than in patients whose urinary tracts are managed by other methods. PATIENTS AND METHODS: Our experience suggested that the incidence of complications in patients with SCI and SPC was acceptable and relatively low. Between 1988 and 2001, 1018 patients were admitted to our unit after SCI; 149 were managed by SPC and we retrospectively reviewed them, with a mean follow-up of 6 years. There were no complications in 49% of patients. Most complications were minor (urinary tract infection 27%, bladder stones 22%) and were easily managed. Only 20 patients had upper tract complications. Nine patients had renal scarring and 14, all quadriplegic, had upper tract calculi. One patient developed well-differentiated superficial transitional cell bladder cancer. CONCLUSIONS: Patients with SCI often prefer SPC than other methods offered to them, because of quality-of-life issues. The incidence of significant complications might not be as high as previously reported, and with a commitment to careful follow-up, SPC can be a safe option for carefully selected patients if adequate surveillance can be ensured.

Sedaghatian spondylometaphyseal dysplasia with pachygyria and absence of the corpus callosum.

We report on a female infant with a metaphyseal dysplasia and a neuronal migration abnormality consistent with a diagnosis of Sedaghatian spondylometaphyseal dysplasia. This child, born to nonconsanguineous Caucasian parents, was hypotonic from birth and experienced recurrent cyanotic episodes within a few hours of delivery. Cerebral imaging revealed absence of the corpus callosum and marked frontotemporal pachygyria. She developed seizures on day 14 of life and died at the age of 17 days. Our case highlights the possibility for neuronal migration abnormalities in Sedaghatian spondylometaphyseal dysplasia and suggests a novel association of the disorder with agenesis of the corpus callosum.

Testicular lipomatosis in Cowden's syndrome.

Cowden's syndrome is either familial or sporadic and is associated with the predominantly postpubertal development of a variety of cutaneous, stromal and visceral neoplasms. The syndrome is associated with mutations of the PTEN gene and is closely related to Bannayan's syndrome in which macrocephaly and benign tumors, especially lipomas and hemangiomas are pathognomic. In PTEN knockout mice testicular tumors have been reported and for this reason we felt it prudent to examine the testes of our patients with genetically proven Cowden's syndrome. Seven of eight patients who underwent testicular ultrasound were found to have diffuse bilateral hyperechoic lesions. Four patients consented to testicular biopsy and on histological examination multiple foci of adipocytes were found within the testicular interstitium, with no evidence of dysplasia or preclinical malignancy. Immunohistochemical assessment of adipocytes suggested a stromal derivation without evidence of metaplasia from Leydig cells. In one case there was focal atrophy of seminiferous tubules, while in two others there was nodular periorchitis of the tunica albuginea. Biochemical evaluation of testicular function (luteinizing hormone, follicle-stimulating hormone, testosterone, sex hormone binding globulin and free androgen index), prostate-specific antigen and testicular tumor markers were normal, while seminal fluid analysis showed only minor abnormalities. The high incidence of testicular lipomatosis in our adult subjects suggests this to be an important diagnostic criterion for Cowden's syndrome.