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Purpose: The aim of this study was to demonstrate features predictive of treatment response for patient‐tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors. Materials and Methods: This study was designed as a follow‐up study based on parameter settings and patients' preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow‐up visits. Results: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow‐up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints. Conclusion: This data underscores the need to use patient‐tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making. [ABSTRACT FROM AUTHOR]

Introduction: The terminology for female pelvic floor fistulas (PFF) needs to be defined and organized in a clinically based consensus Report. Methods: This Report combines the input of members of the International Continence Society (ICS) assisted at intervals by external referees. Appropriate core clinical categories and a sub‐classification were developed to give a coding to definitions. An extensive process of 19 rounds of internal and external review was involved to examine each definition, with decision‐making by collective opinion (consensus). Results: A terminology report for female PFF, encompassing 416 (188 NEW) separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user‐friendliness have been key aims to make it interpretable by practitioners and trainees in different specialty groups involved in female pelvic floor dysfunction and PFF. Female‐specific imaging (ultrasound, radiology, and magnetic resonance imaging) and conservative and surgical PFF managements as well as appropriate figures have been included to supplement and clarify the text. Interval (5–10 years) review is anticipated to keep the document updated and as widely acceptable as possible. Conclusion: A consensus‐based terminology report for female PFF has been produced to aid clinical practice and research. [ABSTRACT FROM AUTHOR]

Aims: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long‐term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2‐year outcomes. Methods: A total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow‐up visits. Adverse events (AEs) are reported in all implanted subjects. Results: At 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device‐related AEs. Conclusions: The Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs. Subjects reported continued satisfaction with their therapy. [ABSTRACT FROM AUTHOR]

Aims: Historically, providing SNM therapy required use of a non‐rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long‐term overactive bladder (OAB) management. A longer‐lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long‐term safety and cost‐effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. Methods: This prospective, multi‐center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72‐h). Outcome measures at 1‐year follow‐up included quality of life (evaluated by ICIQ‐OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). Results: At 1‐year, 94% of Test Responders continued to respond to r‐SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ‐OABqol. 84% of subjects were satisfied with r‐SNM therapy and 98% found their charging experience acceptable. Device‐related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. Conclusions: The Axonics r‐SNM System provides sustained clinically significant improvements in OAB subjects after 1‐year. Subjects were satisfied with r‐SNM therapy and reported an easy and acceptable recharging experience. [ABSTRACT FROM AUTHOR]

Background: Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL. Objective: Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB. Design, Setting, and Participants Intervention: A 6‐month multi‐center prospective intervention study. Outcome Measurements and Statistical Analysis: Objective assessment was done by voiding diary parameters including voids/day, volume voided/day, urgency assessment, leaking episodes/day, pads used/day, leak severity, and clinical success defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency >2 or a return to <8 voids/day on a 3 Day diary. Subjective assessment was based on OAB‐q including HRQL and symptom severity score. Safety was evaluated by adverse event (AE) analysis. Results and Limitations: Thirty‐four of the 36 implanted subjects completed the study. One subject withdrew voluntarily and one developed inflammation necessitating removal of the system. In the remaining subjects, 71% experienced clinical success at 6 months. Leaks/day, leak severity, and pad changes/day decreased significantly over time with 27.6% of urge incontinence subjects that became “dry.” Voids/day, degree of urgency, volume/void, pads changed improved significantly. All quality of life aspects (concern, coping, sleep, and social) improved as well as symptom severity scores measured by the OAB‐q. Adverse events included: implant site pain (13.9%), suspected infection (22.2%), and procedural wound complications (8.3%). Conclusions: The BlueWind implantable tibial nerve stimulator is a safe, minimally invasive system that affords OAB patients significant improvements. Patient Summary: The performance and safety of the BlueWind RENOVA™ implantable tibial nerve neuromodulator for OAB was tested. Our preliminary results demonstrate that the system has a low risk safety profile and may be considered an effective treatment option for OAB management. [ABSTRACT FROM AUTHOR]

Aims: The RELAX‐OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r‐SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects’ ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time. Methods: Fifty‐one OAB patients were implanted in a single‐stage procedure. These results represent the 3‐month charging experience for 48 subjects who completed the 3‐month follow‐up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires. Results: Forty‐seven of forty‐eight (98%) subjects were able to successfully charge their device prior to follow‐up within 1‐month post‐implant. At 3‐month post‐implant, 98% of subjects were able to charge prior to their follow‐up visit. Average stimulation amplitude across all subjects was 1.8 mA (±1.1 mA). A total of 69% of subjects had ≥14‐day recharge intervals (time between charging) and 98% of subjects had ≥7‐day recharge interval. No charging related adverse events occurred. Conclusions: Study subjects were able to charge the Axonics r‐SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy. [ABSTRACT FROM AUTHOR]

Aims: The primary aim of the RELAX‐OAB study is to confirm the safety and efficacy of the Axonics r‐SNM System, a miniaturized, rechargeable SNM system. Methods: A total of 51 OAB patients were implanted in a single‐stage implant procedure. These results represent the 3‐month outcomes. Subject outcomes were evaluated using 3‐day bladder diaries and quality of life questionnaires. Results: A total of 31 of 34 patients (91%) that responded during an initial trial period (“Test Responders”) continued to benefit from therapy with the Axonics r‐SNM System at 3‐months, defined as symptom improvement of ≥50% reduction in urinary voids or incontinence episodes or a return to <8 voids per day. Subjects who were Test Responders showed a statistically and clinically meaningful improvement in all aspects of quality of life (ICIQ‐OABqol). No serious device‐related adverse events (SADEs) occurred, and there were no unanticipated adverse events (UAEs). One subject was explanted due to an infection at the implant site and 19.6% of subjects experienced device related adverse events, most notably discomfort due to stimulation, which was resolved with reprogramming. Conclusions: The Axonics r‐SNM System provides safe and effective SNM therapy with objective improvement in 91% of subjects. The data also demonstrates a significant improvement in all domains of quality of life. This miniaturized, rechargeable system is designed to last 15 or more years and is expected to provide clinical and cost benefits over current non‐rechargeable systems by eliminating replacement surgeries. [ABSTRACT FROM AUTHOR]

Aims Terms used in the field of chronic pelvic pain (CPP) are poorly defined and often confusing. An International Continence Society (ICS) Standard for Terminology in chronic pelvic pain syndromes (CPPS) has been developed with the aim of improving diagnosis and treatment of patients affected by chronic pelvic pain syndromes. The standard aims to facilitate research, enhance therapy development and support healthcare delivery, for healthcare providers, and patients. This document looks at the whole person and all the domains (organ systems) in a systematic way. Methods A dedicated working group (WG) was instituted by the ICS Standardisation Steering Committee according to published procedures. The WG extracted information from existing relevant guidelines, consensus documents, and scientific publications. Medline and other databases were searched in relation to each chronic pelvic pain domain from 1980 to 2014. Existing ICS Standards for terminology were utilized where appropriate to ensure transparency, accessibility, flexibility, and evolution. Consensus was based on majority agreement. Results The multidisciplinary CPPS Standard reports updated consensus terminology in nine domains; lower urinary tract, female genital, male genital, gastrointestinal, musculoskeletal, neurological aspects, psychological aspects, sexual aspects, and comorbidities. Each is described in terms of symptoms, signs and further evaluation. Conclusion The document presents preferred terms and definitions for symptoms, signs, and evaluation (diagnostic work-up) of female and male patients with chronic pelvic pain syndromes, serving as a platform for ongoing development in this field. Neurourol. Urodynam. 36:984-1008, 2017. © 2016 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]