Preliminary results on validity and reliability from two prospective cohort studies on a new Neonatal Coma Score.

OBJECTIVE: To collect data on content/face validity and interobserver agreement for a Neonatal Coma Score (NCS) in well full-term neonates and on construct validity in unwell and preterm babies, specifically how the NCS changed with gestational age and illness. DESIGN: Prospective cohort studies. SETTING: Two UK tertiary neonatal units (Sheffield and Leeds). PATIENTS: 151 well full-term (≥37 weeks gestational age) newborn babies recruited between January and February 2020 in Sheffield and April and May 2021 in Leeds; 101 sick preterm and full-term babies admitted to Sheffield neonatal unit between January 2021 and May 2022. INTERVENTION: A new NCS. MAIN OUTCOME MEASURES: Determination of normal values in well babies born ≥37 weeks gestational age; data on how the NCS changes with gestational age and illness. RESULTS: Face validity was demonstrated during development of the NCS. The median NCS of well, full-term newborn babies was 15 and the intraclass correlation coefficient was 0.78 (95% CI 0.70 to 0.84). In the 'well' preterm population, 95% <28 weeks had a score ≥11; 28-31 weeks ≥11; 32-36 weeks ≥13 and 37-44 weeks 14-15. The NCS dropped during periods of deterioration, demonstrating evidence of construct validity. Criterion validity was not assessed. CONCLUSIONS: The NCS has good intraobserver agreement in well full-term babies, with a normal NCS 14-15. The NCS in preterm neonates depended on gestational age, and deterioration from baseline was associated with illness. Further work is needed to determine normal scores each gestational age, reliability at lower levels, how early the NCS identifies deterioration and comparison with other assessment tools to demonstrate criterion validity.

Fifteen-minute consultation: How to approach the initial discussions of dysmorphism with parents.

Approaching discussions and introducing the idea of dysmorphology to parents and families can be perceived as difficult and even daunting by health professionals resulting in uneasiness in how best to initiate important dialogues sensitively and accessibly.Here, we offer a structured approach to the assessment of, and subsequent initial discussion around, dysmorphism and potential syndromic features in babies and children.

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.

Sonographic features of umbilical catheter-related complications.

Umbilical catheters are commonly used in the neonatal period for blood sampling or for administering medication or parenteral nutrition. The position of the catheter is usually confirmed with radiography. However, many complications associated with the use of umbilical catheters, such as liver collections from extravasation or vascular thrombosis, are not apparent on radiographs but can be easily diagnosed with ultrasound. This pictorial review illustrates the sonographic findings of complications that should be excluded in the sick neonate with an indwelling catheter.

Symptoms of bowel dysfunction and their management after spinal cord injury in a New Zealand centre.

AIM: To document the symptoms of bowel dysfunction, and how the bowels are managed, in a cohort of patients following a spinal cord injury. To relate these to the level of the spinal injury and to examine the relationship between bowel symptoms and bladder dysfunction. METHOD: Participants were identified from the discharge data from the Burwood Spinal Unit, one of two national Spinal Units in New Zealand, in two two-year sets from 1-3 years post-injury and from 20-21 years post-injury. With informed consent, they completed a survey developed for symptoms and management using Survey Monkey. This was cross-related to the level of cord injury and the AIS Scale, and then to the latest urodynamic analysis. RESULTS: A total of 54 patients were included; data was incomplete in five patients. No specific relation was found between bowel sensation, bowel continence, bowel management, nor with bladder function. CONCLUSION: Lack of correlation of patterns of bowel function with the level and severity of the cord lesion indicates the need to continue to individualise advice on bowel care according to symptoms.

Update on voiding dysfunction managed with suprapubic catheterization.

As the population ages the prevalence of long-term urinary catheters, especially in the elderly, is going to increase. Urinary catheters are usually placed to manage urinary retention or incontinence that cannot be managed any other way. There is significant morbidity associated with an indwelling catheter. The commonest problems are catheter blockages, infection and bladder stones. These will occur with a similar incidence with either a suprapubic or a urethral catheter. Urethral complications such as strictures, scrotal infection and erosion are less common with suprapubic catheterization (SPC). However the benefit of having a SPC needs to be balanced against the risks involved in inserting the catheter suprapubically. Patient reported symptoms show that a SPC is more comfortable and better tolerated than a urethral catheter. However there needs to be more research into developing better catheters that reduce the frequency of urinary infections and blockages and hence catheter morbidity.

Conjoint Urological Society of Australia and New Zealand (USANZ) and Urogynaecological Society of Australasia (UGSA) Guidelines on the management of adult non-neurogenic overactive bladder.

Due to the myriad of treatment options available and the potential increase in the number of patients afflicted with overactive bladder (OAB) who will require treatment, the Female Urology Special Advisory Group (FUSAG) of the Urological Society of Australia and New Zealand (USANZ), in conjunction with the Urogynaecological Society of Australasia (UGSA), see the need to move forward and set up management guidelines for physicians who may encounter or have a special interest in the treatment of this condition. These guidelines, by utilising and recommending evidence-based data, will hopefully assist in the diagnosis, clinical assessment, and optimisation of treatment efficacy. They are divided into three sections: Diagnosis and Clinical Assessment, Conservative Management, and Surgical Management. These guidelines will also bring Australia and New Zealand in line with other regions of the world where guidelines have been established, such as the American Urological Association, European Association of Urology, International Consultation on Incontinence, and the National Institute for Health and Care Excellence guidelines of the UK.

Conservative treatment for incontinence in women in rest home care in Christchurch: Outcomes and cost.

AIMS: To assess if conservative therapy can reduce urinary leakage and pad usage and improve quality of life in elderly incontinent women living in a rest home setting; and if so at what additional cost. METHODS: Sixty-eight elderly women with urinary incontinence, and preserved cognitive ability, living in 26 rest homes were identified. Clinical evaluation, included bladder diary, pad weigh tests, pad usage, and quality of life and activities questionnaires (FIM: Functional Impairment Measure; EQ-5D: Euroquol 5 dimension score; ICIQ-SF: International Consultation on Incontinence-Short Form). A specialist Continence Advisor Nurse provided conservative treatment according to the needs of each participant. Outcomes were recorded after 12 weeks of treatment by repeating above evaluations, and the costs involved were measured. RESULTS: Leakage was reduced by a mean of 60 ml per 24 hr, and four fewer pads were required per week. The ICIQ-SF improved significantly. The EQ-5D did not demonstrate significant improvement, so a cost-utility analysis was not possible. The mean cost of the Advisor's time and mileage in providing the 12 week course was $247.75 per participant. CONCLUSION: Conservative therapies tailored to each individual, can improve the severity of leakage in the short term, even in this elderly group of women with preserved cognitive function, at modest additional cost. Measuring quality of life and the impact of incontinence, has challenges in this age group. Neurourol. Urodynam. 35:636-641, 2016. © 2015 Wiley Periodicals, Inc.

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.