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.

Direct cost of hysterectomy: comparison of robotic versus other routes.

The aim of this study was to investigate the direct cost of robotic hysterectomy in comparison with abdominal, vaginal, and laparoscopic routes past the initial learning curve. We examined a consecutive case series of 348 patients undergoing abdominal (AH), vaginal (VH), laparoscopic (LH), or robotic hysterectomy (RH) for benign conditions between January 2015 and March 2017. The primary outcome was the direct cost of hysterectomy, while the secondary outcome was length of stay. Multiple linear regression was used to examine the cost and length of stay across the four hysterectomy groups after controlling for potential confounding variables. 19 (5.5%) patients underwent AH, 53 (15.2%) LH, and 59 (16.9%) VH, while 217 (62.4%) RH. VH group was the oldest at age 52.1 years (p < 0.01), whereas AH group had the highest BMI at 35.9 kg/m2 (p = 0.03). While colporrhaphy was most frequently performed in VH (81%), mid-urethral sling was most common in RH (30%) (p < 0.01). The average direct cost was $3865 for RH, $4063 for AH, $2791 for VH, and $3818 for LH. Upon multivariate analysis, RH and VH were $650.47 (p < 0.01) and $883.07 (p < 0.01) cheaper, respectively, compared to AH. The average length of stay was the shortest for RH at 10.7 h, followed by LH at 15.5 h, vaginal at 20 h, and abdominal at 51.5 h (p < 0.01). VH has the lowest direct cost, while AH has the highest. Both VH and RH have a significantly lower cost than that of AH. RH has the shortest hospital stay, whereas AH has the longest.

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.

Vesicovaginal fistula resulting from a well-cared-for pessary.

An 84-year-old vaginally grand multiparous woman presented with a vesicovaginal fistula (VVF) after appropriate use of a Gehrung pessary for the past 12 years for stage III pelvic organ prolapse. The patient reported strict adherence to removing her pessary nightly and replacing it in the morning for the last 12 years. One morning, she awoke and noted a sudden gush of urine through the vagina followed by continuous leakage. Given the complex nature of VVF repair with concurrent stage III pelvic organ prolapse, the patient was referred to urogynecologic care. A Latzko fistula repair and LeFort colpocleisis were performed without complication. The patient recovered well with complete resolution of her pelvic organ prolapse and VVF based on negative cystogram findings at 3 weeks postoperatively. At 12 weeks postoperatively the patient denied any urine leakage or pelvic organ prolapse.

Spontaneous intrapartum vesicouterine fistula.

BACKGROUND: Vesicouterine fistulae as an obstetrical complication have been reported only in women with a history of cesarean. We present a patient with no such history who developed a vesicouterine fistula after vaginal delivery. CASE: A 43-year-old gravida 5 at term with no history of cesarean presented in the latent phase of labor. Gross hematuria was noted intrapartum, and a foley catheter was placed. A cystogram showed an extraperitoneal bladder perforation. The patient had urinary incontinence despite Foley catheter drainage. The diagnosis of vesicouterine fistula was made by cystoscopy and fistulogram. The patient had a successful repair at 3 months. CONCLUSION: This is a rare case of a vesicouterine fistula developing during a pregnancy with no previous cesarean. Accurate diagnosis is essential because surgical repair has an excellent outcome.