A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Results at 1 Year from SATURN, A European, Prospective, Multicenter Registry for Male Stress Urinary Incontinence Surgery.

BACKGROUND AND OBJECTIVE: The European, prospective, multicenter SATURN registry was developed to analyze surgical devices for male stress urinary incontinence. The primary objective is the cure rate during follow-up. METHODS: Efficacy, complications, patient-reported outcomes, and prognostic factors are being analyzed at various intervals during 10-yr follow-up. The results at 1-yr follow-up are presented here. KEY FINDINGS AND LIMITATIONS: The cohort included 1046 patients (mean age 70 yr) from 28 centers in nine countries. The main cause of incontinence was radical prostatectomy (83.5%), followed by radiotherapy (4.5%), endourological procedures (9.7%), neurogenic conditions (1.0%), and trauma (0.2%). Some 19.5% of the patients underwent at least one incontinence procedure before registry inclusion. A baseline pad test was performed in 64% of the patients (mean 525 g, range 3.5-3600), urodynamics in 66%, and cystoscopy in 80%. The main implants used were AMS800 (n = 684) and Advance (n = 210) devices, followed by Atoms (n = 63) Victo/Plus (n = 33), ProACT (n = 30), and others (n = 24). A total of 896 patients had 1-yr follow-up data, of whom 164 completed a 1-yr pad test. Self-reported complete incontinence rates at baseline by device were as follows: Advance, 17%; other slings, 33%; ProACT, 0%; AMS800, 49%; other sphincter prosthesis, 100%; and overall group, 44%. The corresponding 1-yr self-reported continence rates were 73%, 37%, 50%, 76%, 11%, and 68%. Some 32% of the patients were still incontinent. Overall, 132 patients had at least one revision. Among the 110 patients with an artificial urinary sphincter (AUS), 122 revisions were performed, while there were 29 revisions for the 22 patients with a sling or ProACT device. International Consultation on Incontinence Questionnaire Short Form and EuroQol 5-dimensions 5-levels scores improved with all devices. CONCLUSIONS AND CLINICAL IMPLICATIONS: AUS implants are used in cases with more severe incontinence and are associated with better outcomes but more revisions than the alternatives. Patients report that every improvement is important. Choices for procedures should be made on the basis of these considerations. PATIENT SUMMARY: We collected data from 29 urology departments in Europe on surgical treatments for patients who suffer from incontinence during exercise, sneezing, and coughing. Results after 1 year show that an artificial urinary sphincter has the best outcomes overall and for patients with heavy urine loss. However, this surgery also requires more revisions. Patients report that every improvement in continence is important to them.

Quality of Life and Treatment Modalities in Patients with Interstitial Cystitis: The Patients' Perspective.

BACKGROUND: Quality of life (QoL)-based outcomes are hardly incorporated into interstitial cystitis/bladder pain syndrome (IC/BPS) guidelines, because studies are limited and outdated. Therefore, guidelines might not reflect the current clinical situation accurately. Secondly, guidelines suggest using a multimodal approach for BPS/IC management, but data on the patient-perceived efficacy of these therapies are limited. The aim of this study is to investigate the perception of IC/BPS patients of their QoL, to determine which treatments they have received, and to examine how they evaluate the efficacy of these various (alternative) therapies. METHODS: A quantitative retrospective database evaluation was performed, with data from an existing IC/BPS patient survey (n = 217) that was conducted in 2021. This survey contained QoL data based on validated questionnaires such as EQ-5D 5L. RESULTS: The QoL of patients is affected significantly by IC/BPS. This is evident from the various affected domains on the EQ-5D 5L. The symptom severity was negatively affected by a delay in diagnosis, and there were clear differences in QoL domains between females and males. Secondly, coagulation therapy and intravesical glycosaminoglycan (GAG) therapy were most appreciated by patients. Other (alternative) treatments were commonly utilized, although some had doubtful results and high discontinuation rates. CONCLUSION: QoL is considerably impaired in IC/BPS patients. The diverse responses and adherence to various treatments warrant a personalized approach (phenotype-oriented therapy). To achieve QoL improvement, it is important to incorporate the patient's perspective in treatment guidelines.

SATURN: A European, Prospective, Multicentre Registry for Male Stress Urinary Incontinence Surgery.

Surgery for male incontinence with artificial urinary sphincters and slings (SATURN) is a prospective, multicentre registry (observational cohort) for male stress urinary incontinence surgery to collect prospective data from multiple European centres and surgeons, to evaluate the short- and long-term success and the impact on quality of life.

The Burden of Urinary Tract Infections on Quality of Life and Healthcare in Patients with Interstitial Cystitis.

BACKGROUND: Interstitial cystitis/bladder pain syndrome (IC/BPS) patients are more susceptible to urinary tract infections (UTIs), likely worsening pre-existing symptoms. However, this receives limited attention in guidelines. This study aimed to explore the burden of UTIs on IC/BPS patients' quality of life and their healthcare. METHODS: Two quantitative retrospective database studies were conducted in cystoscopically proven IC/BPS patients: one compiled existing patient survey data (n = 217) from July 2021 to examine physical and emotional UTI burden, and the other used a patient file database (n = 100) from January 2020 to May 2022, focusing on UTI prevalence, healthcare use, urine cultures and antibiotic resistance. RESULTS: A delay in diagnosis was seen in 70% of patients, due to doctors confusing IC/BPS symptoms with UTIs. The UTI prevalence was over 50%; these patients also report anxiety for new UTIs (70%) and worsening of IC/BPS symptoms (60%). Additionally, for UTI+ patients, healthcare consumption was significantly increased in both studies. Antibiotic resistance (80% of cultures) and prophylactic antibiotic use were common. CONCLUSIONS: These findings highlight the burden of UTIs on quality of life in IC/BPS patients and the healthcare system. These results emphasize the need for improved UTI guidelines concerning diagnosis, management and prevention for IC/BPS patients to improve quality of life and care.

Study protocol of a multicentre double-blind RCT, comparing a traditional RCT with an aggregated N-of-1 trial: GAG therapy Efficacy Trial Solution for Bladder pain syndrome/Interstitial cystitis (GETSBI study).

INTRODUCTION: Obtaining level 1 evidence on efficacy of glycosaminoglycan (GAG) therapy is difficult, due to low incidence of bladder pain syndrome/interstitial cystitis (BPS/IC) and heterogeneous symptoms experienced by patients with BPS/IC. Currently, because of a lack of high-grade evidence, the recommendation for applying GAG therapy in most guidelines is 'low grade'. An aggregated N-of-1 trial is a multicrossover design that yields similar level 1 evidence as a traditional randomised controlled trial (RCT), while requiring far less patients. The goal of this study is to investigate the efficacy of intravesical GAG therapy (Ialuril) for patients with BPS/IC with Hunner lesions using a dual RCT and aggregated N-of-1 trial design to obtain level 1 evidence. METHODS AND ANALYSIS: The GETSBI study is a double-blind multidesign multicentre randomised placebo-controlled study to assess the short-term and long-term efficacy of hyaluronic acid (1.6%) + chondroitin sulfate (2%) therapy (Ialuril Prefill, IBSA, Goodlife) in patients with symptomatic BPS/IC with Hunner lesions. It starts as a standard RCT (n=80), but continues as an aggregated N-of-1 trial. There are three parallel arms, receiving blinded treatment for three periods (1 x/week for 6 weeks, ratio placebo to intervention in periods of 2:1). Followed by an open prospective part for the long-term efficacy. The primary study outcome is the maximum bladder pain experienced in the last 3 days measured using the visual analogue pain scale (0-10).This study is a collaboration with the Dutch government and will deliver evidence for the decision to reimburse the therapy. Furthermore, this multidesign study will allow us to compare the two main methods to evaluate applicability for future study designs for BPS/IC research. ETHICS AND DISSEMINATION: Ethical approval was given by METC Oost-Nederland, file number: 2020-7265, NL-number: NL76290.091.20. Findings from this study will be disseminated via publication, reports and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier (NCT number): NCT05518864.

Molecular Processes in Stress Urinary Incontinence: A Systematic Review of Human and Animal Studies.

Stress urinary incontinence (SUI) is a common and burdensome condition. Because of the large knowledge gap around the molecular processes involved in its pathophysiology, the aim of this review was to provide a systematic overview of genetic variants, gene and protein expression changes related to SUI in human and animal studies. On 5 January 2021, a systematic search was performed in Pubmed, Embase, Web of Science, and the Cochrane library. The screening process and quality assessment were performed in duplicate, using predefined inclusion criteria and different quality assessment tools for human and animal studies respectively. The extracted data were grouped in themes per outcome measure, according to their functions in cellular processes, and synthesized in a narrative review. Finally, 107 studies were included, of which 35 used animal models (rats and mice). Resulting from the most examined processes, the evidence suggests that SUI is associated with altered extracellular matrix metabolism, estrogen receptors, oxidative stress, apoptosis, inflammation, neurodegenerative processes, and muscle cell differentiation and contractility. Due to heterogeneity in the studies (e.g., in examined tissues), the precise contribution of the associated genes and proteins in relation to SUI pathophysiology remained unclear. Future research should focus on possible contributors to these alterations.

Patient-tailored healthcare and tibial nerve neuromodulation in the treatment of patients with overactive bladder symptoms.

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.

Real-life patient experiences of TTNS in the treatment of overactive bladder syndrome.

INTRODUCTION AND OBJECTIVES: Overactive bladder syndrome (OAB) is defined as urinary urgency, with or without urgent urinary incontinence; it is often associated with urinary frequency and nocturia, in the absence of any pathological or metabolic conditions that may cause or mimic OAB. The aim of this study was to evaluate the long-term real-life adherence of transcutaneous tibial nerve stimulation (TTNS) in the treatment of OAB, patient satisfaction of the treatment, and reasons for quitting therapy. MATERIALS AND METHODS: In this single center study, all patients who had a positive effect on percutaneous tibial nerve stimulation (PTNS) and continued to receive home-based treatment with TTNS since 2012 were included for analysis. Patients were retrospectively asked to fill out a questionnaire regarding satisfaction, reasons for quitting, and additional or next line of therapy. RESULTS: We included 42 patients for this study, 81% of these patients were female (n = 34). The median age was 67 years (range 36-86). Most of the patients (64%, n = 27) were diagnosed with OAB wet. The median TTNS treatment persistence was 16 months (range 1-112 months). Reasons and percentages for stopping therapy were: 55% stopped treatment due to loss of effect, and 24% stopped because of preferring other type of neuromodulation. The mean satisfaction score (scale 1-10) in patients who continued TTNS was 6.2 (n = 9, SD 1.30) versus 5.4 (n = 29, SD 2.24) for patients who quit therapy. We did not find a statistically significant difference between the two groups (p = 0.174). CONCLUSION: TTNS, although effective in the short-term, is not effective in the long-term. In combination with a low satisfaction rate among patients, there is a need for improvement in terms of OAB treatment modalities.

Vesico-Vaginal Fistula Repair by a Vaginal Approach.

INTRODUCTION: The aim of this study is to determine the outcome of surgically treated vesico-vaginal fistulae (VVaFs) using a transvaginal approach with a Latzko technique. METHODS: A retrospective chart study was conducted at the Department of Urology, Radboud University Medical Centre. Surgical approaches to repair VVaF, from 2014 to September 2020, were selected. Patients who underwent a transvaginal approach were included. The primary objective was fistula closure. Secondary objectives were predictive factors for the outcome of the surgical procedure, for example, patient characteristics, leakage on cystography 2 weeks postoperative, and surgery time. RESULTS: Thirty-one patients had surgery for VVaF. Twenty-five procedures (81%) were performed transvaginally. Thirteen of these (52%) had successful transvaginal closure after the first attempt. Seven out of 12 had their second attempt at the time of analysis, of which 4 (57%) were successfully closed thereafter. After either 1 or 2 attempts with the transvaginal approach, 17 (68%) of the VVaFs were successfully closed, but 79% if patients who did not yet had a second attempt were taken into account with the current success extrapolated. Only few minor complications were observed. CONCLUSION: Transvaginal closure of VVaFs with a Latzko technique is successful in about 79% in either 1 or 2 attempts, with few minor complications. A second attempt in closing the fistula with a transvaginal approach is useful, and a previous transvaginal attempt is not a contraindication for a second transvaginal attempt in closing the VVaF surgically.

The functioning and the complication rate of extreme long existing urinary diversions.

PURPOSE OF REVIEW: This review is timely and relevant because many patients live many years with urinary diversions. Knowledge about the long term outcome with respect to function and complications are important for patient counseling and for the manner to follow-up patients. This study was performed to investigate the functioning of urinary diversions constructed > 25 years earlier. RECENT FINDINGS: Most studies have a relatively shorter follow-up, mainly focussing on short term postoperative complications. Focussing on the long term, urinary tract infections (UTI) including pyelonephritis are common. Mild kidney function deterioration is described. SUMMARY: Retrospective study (2018-2019); 43 patients with regular follow-up at the Radboud University Medical Centre Nijmegen the Netherlands. Ileal conduit (n = 19) and ureterosigmoidostomy (n = 11) are the most common diversion types for reasons such as: bladder exstrophy (n = 15), urinary incontinence (n = 9) and malignancy (n = 8). This series with a median follow-up of 40 years, shows it is possible to live and cope with a urinary diversion for a very long time. Ureterosigmoidostomies give relatively good results. Ileal conduits are functioning properly with acceptable complication rates. 95% suffers from chronic UTI's. Kidney function deterioration was mild. Diversions for benign reasons have more complex complications compared to diversion constructed for malignant reasons. VIDEO ABSTRACT: http://links.lww.com/COU/A32.

Urodynamic Effects of Prostatic Urethral Lift Procedure for Male Voiding Lower Urinary Tract Symptoms.

Aims: Primary objective is to investigate whether prostatic urethral lift (PUL) results in an improvement of urodynamic parameters that define bladder outlet obstruction (urethral resistance algorithm [urethral resistance factor (URA)], Schäfer grade, detrusor pressure at maximum flow [PdetQmax], and detrusor pressure at bladder opening [PdetOpen]). Materials and Methods: Twenty patients (main inclusion criteria: ≥50 years of age, benign prostatic obstruction (BPO), international prostate symptom score (IPSS) ≥13, prostate volume ≤60 mL, and no middle prostate lobe) were enrolled in the study and a PUL was performed. Patients underwent urodynamic investigation and filled out the IPSS and quality of life (QoL) before and after PUL. A paired t-test was used to analyze the results. Results: The mean age was 68 years (range 55-79), mean prostate volume (TRUS) was 45 mL (range 20-59), and mean prostate-specific antigen was 2.0 µg/L (0.2-4.4). IPSS of the 16 patients reduced significantly (from 22.20 to 14.47, p = 0.000). Qmax during pressure flow study improved significantly (from 4.5 to 7.2 mL/s, p = 0.001), no significant difference was found in Qmax during free uroflowmetry. There was no significant difference found in postvoiding residual. URA decreased significantly post-treatment (from 52 to 37 cmH2O, p = 0.000). The Schäfer obstruction plot decreased significantly (from 3.5 to 2.6, p = 0.022). Seven patients underwent Greenlight Laser Vaporization of the prostate after the PUL attributable to unsatisfactory results. Conclusions: PUL has desobstructive effects, but they seem clinically modest. The procedure improves urodynamic parameters as well as QoL in males with lower urinary tract symptoms based on BPO. However, the mechanism how PUL leads to a remarkable symptom relief remains unclear and cannot be explained by the desobstructive mechanisms we observed.

Pain after midurethral sling; the underestimated role of mesh removal.

INTRODUCTION: The primary aim of this study was to evaluate the results of midurethral sling (MUS) removal in women who have pain as their single complication of MUS. MATERIAL AND METHODS: We performed a retrospective chart study supplemented with a cross sectional questionnaire. Women who underwent MUS removal for pain as the solitary reason for removal between 2004 and 2018 were included. Primary outcome was change in pain levels assessed by the visual analogue scale (VAS) pain score (range 0-10). Secondary outcome was the recurrence of stress urinary incontinence (SUI). RESULTS: Twenty-six of 31 patients returned the questionnaire. Median medical file follow-up was 12 months (range 2-66) and 25 months (range 5-104) regarding questionnaires. VAS pain score dropped from 7.8 (SD 1.9) at baseline to 4.5 (SD 3.2) at follow-up (p <.00). Seven (23%) patients were pain-free. Patients undergoing partial vaginal resection (n = 6) had a VAS pain score decrease of 4.7 (p = .02) versus 2.7 (p = .02) for complete vaginal removal (n = 14). Twenty-three (89%) patients experienced SUI at follow-up, whereof 10 (45%) reported (almost) no incidents of SUI. CONCLUSIONS: MUS removal is a viable and safe option with a significant drop in VAS pain score in patients with chronic pain after MUS placement. A post-operative increase of SUI and a possible renewed wish for SUI treatment have to be considered. This should not be a reason to refrain from information and/or referral for surgical removal.

Association between levator ani avulsion and urinary incontinence in women: A systematic review and meta-analysis.

BACKGROUND: Urinary incontinence is a bothersome symptom. Although the relationship between stress urinary incontinence (SUI) and vaginal delivery is established, the pathology underlying SUI after vaginal birth remains to be elucidated. OBJECTIVES: To determine whether levator ani muscle avulsion predisposes for SUI in women. SEARCH STRATEGY: Pubmed and Embase were searched for terms and their variations "levator ani muscle avulsion" and "urinary incontinence", from inception until 5 November 2019. SELECTION CRITERIA: Inclusion criterion: studies describing the relationship between urinary incontinence and levator ani muscle avulsion in women at least 1 year after delivery. Exclusion criterion: studies only analyzing the urethral sphincter or hiatus dimensions. DATA COLLECTION AND ANALYSIS: Odds ratios were used and if not available, were calculated as means of data synthesis, adjusted odds ratios if presented by the study, random-effects model to compute a pooled estimate. RESULTS: Seven studies were included, accounting for 2388 women. Comparing women with and without levator ani muscle avulsion, the overall odds ratio for SUI is 0.87 (95% confidence interval 0.56-1.34), and after adjustment for possible confounders was 0.72 (95% confidence interval 0.40-1.30). CONCLUSION: There is no relationship between levator ani muscle avulsion and SUI in women.

Is the value of urodynamics undermined by poor technique?: ICI-RS 2018.

INTRODUCTION: The quality of urodynamic measurements in clinical practice has been debated as a matter of concern. It is considered plausible that this has a direct bearing on patient care and the perceived value of urodynamic testing. METHODS: This is a report of the proceedings of the Think Tank: "Is the value of urodynamics undermined by poor technique?" from the Annual International Consultation on Incontinence-Research Society, which took place in June 2018 in Bristol, UK. The Think Tank discussed the evidence for deficiencies in urodynamic test quality and considered the implications of improvements for clinical diagnosis and practice. RESULTS: There is evidence that technique affects urodynamic quality, and that urodynamic practice is variable. Factors such as team skill set, technologies used, and training received will also affect the quality of urodynamic service. Questions exist regarding the influence of technique on the utility and perceived value of urodynamics. CONCLUSIONS: We suggest research questions that will provide the necessary evidence on the link between technique, reporting, and outcome, and clarify the role of good practice in the utility of urodynamic testing.

Pathophysiological mechanisms in detrusor underactivity: Novel experimental findings.

Underactive bladder (UAB) is a multifactorial symptom complex often related to detrusor underactivity (DU). Although recognized as a common cause of lower urinary tract symptoms and with significant effects on quality of life, UAB/DU is largely underresearched. Herein, we review up-to-date knowledge on the pathophysiological mechanisms of UAB/DU, with an emphasis on the relationship between UAB and bladder outlet obstruction (BOO). Original articles and reviews concerning UAB/DU were identified through a search of the PubMed/Medline and Scopus databases. DU can result from several pathological mechanisms, which can be categorized as idiopathic, neurogenic, myogenic, or functional. The main etiological factors of UAB/DU are aging, diabetes mellitus, neurogenic disorders, and BOO. Although conventional models focus primarily on efferent nerve and myogenic mechanisms, contemporary views highlight the importance of the afferent pathway. Specifically, recent findings in BOO showed that afferent dysfunction, such as altered expression of muscarinic and purinergic P2X3 receptors or diminished urothelial ATP may play a role in the initial and reversible stages of DU, with potential diagnostic and therapeutic implications.

Clinical utility of neurostimulation devices in the treatment of overactive bladder: current perspectives.

OBJECTIVES: This review describes the evidence from established and experimental therapies that use electrical nerve stimulation to treat lower urinary tract dysfunction. METHODS: Clinical studies on established treatments such as percutaneous posterior tibial nerve stimulation (P-PTNS), transcutaneous electrical nerve stimulation (TENS), sacral nerve stimulation (SNS) and sacral anterior root stimulation (SARS) are evaluated. In addition, clinical evidence from experimental therapies such as dorsal genital nerve (DGN) stimulation, pudendal nerve stimulation, magnetic nerve stimulation and ankle implants for tibial nerve stimulation are evaluated. RESULTS: SNS and P-PTNS have been investigated with high-quality studies that have shown proven efficacy for the treatment for overactive bladder (OAB). SARS has proven evidence-based efficacy in spinal cord patients and increases the quality of life. TENS seems inferior to other OAB treatments such as SNS and P-PTNS but is noninvasive and applicable for ambulant therapy. Results from studies on experimental therapies such as pudendal nerve stimulation seem promising but need larger study cohorts to prove efficacy. CONCLUSION: Neurostimulation therapies have proven efficacy for bladder dysfunction in patients who are refractory to other therapies. SIGNIFICANCE: Refinement of neurostimulation therapies is possible. The aim should be to make the treatments less invasive, more durable and more effective for the treatment of lower urinary tract dysfunction.

A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center.

PURPOSE: This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms. MATERIALS AND METHODS: A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires. RESULTS: Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection. CONCLUSIONS: This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results.

An estimated glomerular filtration rate equation for the full age spectrum.

BACKGROUND: Glomerular filtration rate (GFR) is accepted as the best indicator of kidney function and is commonly estimated from serum creatinine (SCr)-based equations. Separate equations have been developed for children (Schwartz equation), younger and middle-age adults [Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation] and older adults [Berlin Initiative Study 1 (BIS1) equation], and these equations lack continuity with ageing. We developed and validated an equation for estimating the glomerular filtration rate that can be used across the full age spectrum (FAS). METHODS: The new FAS equation is based on normalized serum creatinine (SCr/Q), where Q is the median SCr from healthy populations to account for age and sex. Coefficients for the equation are mathematically obtained by requiring continuity during the paediatric-adult and adult-elderly transition. Research studies containing a total of 6870 healthy and kidney-diseased white individuals, including 735 children, <18 years of age, 4371 adults, between 18 and 70 years of age, and 1764 older adults, ≥70 years of age with measured GFR (inulin, iohexol and iothalamate clearance) and isotope dilution mass spectrometry-equivalent SCr, were used for the validation. Bias, precision and accuracy (P30) were evaluated. RESULTS: The FAS equation was less biased [-1.7 (95% CI -3.4, -0.2) versus 6.0 (4.5, 7.5)] and more accurate [87.5% (85.1, 89.9) versus 83.8% (81.1, 86.5)] than the Schwartz equation for children and adolescents; less biased [5.0 (4.5, 5.5) versus 6.3 (5.9, 6.8)] and as accurate [81.6% (80.4, 82.7) versus 81.9% (80.7, 83.0)] as the CKD-EPI equation for young and middle-age adults; and less biased [-1.1 (-1.6, -0.6) versus 5.6 (5.1, 6.2)] and more accurate [86.1% (84.4, 87.7) versus 81.8% (79.7, 84.0)] than CKD-EPI for older adults. CONCLUSIONS: The FAS equation has improved validity and continuity across the full age-spectrum and overcomes the problem of implausible eGFR changes in patients which would otherwise occur when switching between more age-specific equations.