Perspectives on technology: Single-use catheters - evidence and environmental impact.

OBJECTIVE: To explore the data comparing single- vs multi-use catheters for clean intermittent catheterisation (CIC), consider if the widespread use of single-use catheters is warranted given the cost and environmental impact, and put forth ideas for future consideration. METHODS: A primary literature review was performed in PubMed over the past 50 years. Studies that performed comparative analysis of single- and multi-use catheters were included in our review. All studies that reported on primary data were narratively summarised. RESULTS: A total of 11 studies were identified that reported on primary data comparing single- and multi-use catheters. There was no appreciable evidence suggesting reusable multi-use catheters were inferior to single-use catheters from an infection or usability standpoint. In addition, the environmental and monetary burden of single-use catheters is significant. CONCLUSIONS: The intermittent catheter landscape in the USA has a complex past: defined by policy, shaped by industry, yet characterised by a paucity of data demonstrating superiority of single-use over multi-use catheters. We believe that the aversion to reusable catheters by many patients and healthcare professionals is unwarranted, especially given the cost and environmental impact. Moving forward, better comparative data and more sustainable practices are needed.

Determining patient preferences in the treatment of medication-refractory overactive bladder.

INTRODUCTION: Overactive bladder (OAB) is often suboptimally addressed by behavioral or pharmacological treatments. Less than 15% of patients choose to pursue advanced OAB therapy (sacral nerve stimulation [SNS], percutaneous tibial nerve stimulation [PTNS], and bladder onabotulinum toxin type-A [BTX-A]). We seek to better understand which factors are most important to patients when choosing a third-line therapy. METHODS/MATERIALS: We developed a conjoint analysis survey that included five attributes of the third-line options for OAB (SNS, PTNS, and BTX-A). We administered the survey to new patients with urinary incontinence at two institutions. A hierarchical Bayes random effects regression analysis was used to determine the relative importance of the attributes. A choice simulator was used to model which third-line treatment options patients preferred. We followed patients to see if they pursued their predicted treatment. RESULTS: A total of 108 patients completed the study of whom 89% were women. There was representation from all age groups. The most important attributes of decision-making were the frequency of future procedures, the risk of catheterization, and the need for a device. On market simulation, SNS was the preferred treatment option (47%), followed by PTNS (29%) and BTX-A (14%). Only 10% of patients did not find any treatment option acceptable. CONCLUSIONS: Frequent follow-up, risk of catheterization, and the need for a device were the most important attributes when making a decision on third-line OAB therapy. On market simulation, SNS is the preferred treatment for all age groups though the ultimate choice in third-line therapy may be affected by external factors.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

Incontinence after Prostate Treatment: AUA/SUFU Guideline.

PURPOSE: Urinary incontinence after prostate treatment (IPT) is one of the few urologic diseases that is iatrogenic, and, therefore, predictable and perhaps preventable. Evaluation of the incontinent patient, risk factors for IPT, the assessment of the patient prior to intervention, and a stepwise approach to management are covered in this guideline. Algorithms for patient evaluation, surgical management, and device failure are also provided. MATERIALS AND METHODS: This guideline was developed using a systematic review from the Mayo Clinic Evidence Based Practice Center with additional supplementation by the authors. A research librarian conducted searches from 2000 to December 21st, 2017 using Ovid, MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Databases of Systematic Reviews. Additional references through 12/31/2018 were identified. RESULTS: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with IPT and the safe and effective management of the condition in both surgical and non-surgical contexts. Statements guiding the clinician on proper management of device failure are also included. CONCLUSION: Most patients who undergo radical prostatectomy (RP), and some patients who undergo radiation therapy (RT) or surgery for benign prostatic hyperplasia (BPH), will experience IPT. Although non-surgical options, such as pelvic floor muscle exercises (PFME), can hasten continence recovery, patients who remain incontinent at one-year post-procedure, or have severe incontinence at six months, may elect to undergo surgical treatment (e.g. artificial urinary sphincter). Prior to IPT surgery, the risks, benefits, alternatives, and additional likely procedures should be discussed with the patient.

To stage or not to stage?-A cost minimization analysis of sacral neuromodulation placement strategies.

AIMS: Sacral neuromodulation (SNM) is a standard therapy for refractory overactive bladder (OAB). Traditionally, SNM placement involves placement of an S3 lead with 1-3 weeks of testing before considering a permanent implant. Given the potential risk of bacterial contamination during testing and high success rates published by some experts, we compared the costs of traditional 2-stage against single-stage SNM placement for OAB. METHODS: We performed a cost minimization analysis using published data on 2-stage SNM success rates, SNM infection rates, and direct reimbursements from Medicare for 2017. We compared the costs associated with a 2-stage vs single-stage approach. We performed sensitivity analyses of the primary variables listed above to assess where threshold values occurred and used separate models for freestanding ambulatory surgery centers (ASC) and outpatient hospital departments (OHD). RESULTS: Based on published literature, our base case assumed a 69% SNM success rate, a 5% 2-stage approach infection rate, a 1.7% single-stage approach infection rate, and removal of 50% of non-working single-stage SNMs. In both ASC ($17 613 vs $18 194) and OHD ($19 832 vs $21 181) settings, single-stage SNM placement was less costly than 2-stage placement. The minimum SNM success rates to achieve savings with a single-stage approach occur at 65.4% and 61.3% for ASC and OHD, respectively. CONCLUSIONS: Using Medicare reimbursement, single-stage SNM placement is likely to be less costly than 2-stage placement for most practitioners. The savings are tied to SNM success rates and reimbursement rates, with reduced costs up to $5014 per case in centers of excellence (≥ 90% success).

Surgical treatment of post-prostatectomy stress urinary incontinence in adult men: Report from the 6th International Consultation on Incontinence.

AIMS: To report the recommendations of the 6th International Consultation on Incontinence (ICI) on post-prostatectomy urinary incontinence. METHODS: The 6th ICI committee on surgical treatment of urinary incontinence in men assessed and reviewed the outcomes of surgical therapy and updated the prior recommendations published in 2013. Articles from peer-reviewed journals, abstracts from scientific meetings, and literature searches by hand and electronically formed the basis of this review. The resulting guidelines were presented at the 2016 ICI meeting in Tokyo, Japan. RESULTS: Voiding diary and pad tests are valuable for assessing quantity of leakage. Cystoscopy and/or urodynamics may be useful in guiding therapy depending on the type of incontinence and presumed etiology. Artificial Urinary Sphincter (AUS) is the preferred treatment for men with moderate to severe stress urinary incontinence (SUI) after RP. Male slings are an acceptable approach for men with mild to moderate SUI. Much discussion centers on the definition of moderate SUI. Injectable agents have a poor success rate in men with SUI. Options for recurrent SUI due to urethral atrophy after AUS implantation include changing the pressure balloon, downsizing the cuff and increasing the amount of fluid in the system. Infection and/or erosion demand surgical removal or revision of all or part of the prosthesis. CONCLUSIONS: Although there are several series reporting the outcomes of different surgical interventions for PPUI, there is still a need for prospective randomized clinical trials. Recommendations for future research include standardized workup and outcome measures, and complete reporting of adverse events at long-term.

First-in-human implantation of a mid-field powered neurostimulator at the sacral nerve: Results from an acute study.

INTRODUCTION: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. MATERIALS AND METHODS: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. RESULTS: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. CONCLUSIONS: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.

Outcomes of Sacral Nerve Stimulation for Treatment of Refractory Overactive Bladder Among Octogenarians.

OBJECTIVE: Sacral nerve stimulation (SNS) is an effective treatment for refractory overactive bladder (OAB). However, advanced age is often cited as a reason to avoid SNS in the elderly. This study evaluates the safety and efficacy of SNS for refractory OAB among our octogenarian population. METHODS: A retrospective review from a single institution was performed on all SNS lead placements from December 1998 to June 2017 for refractory OAB. Octogenarians were characterized as 80 years of age or older at the time of Stage I. Efficacy and safety were determined by the rate of progression to Stage II, subsequent need for multimodal therapy, and rate of surgical revision and explantation. All patients were followed for a minimum of 12 months. RESULTS: Of 374 patients in this study, 37 (9.9%) were octogenarians. There was no difference in gender, race, smoking history, or prior OAB treatment regimens between cohorts. The rate of progression to Stage II was 56.8% for octogenarians compared to 60.5% for nonoctogenarians (p = 0.66). The rate of surgical revision, explantation, and need for multimodal therapy did not differ between groups. Subgroup analysis of octogenarians did not reveal any significant differences between successful and nonsuccessful Stage I patients. CONCLUSIONS: The safety and efficacy of SNS was similar between cohorts. This result suggests that SNS is a safe and effective therapy that should be considered among the treatment options for refractory OAB in octogenarian patients. Further studies are needed to determine predictive factors of Stage I success in elderly patients.

Volitional Voiding of the Bladder after Spinal Cord Injury: Validation of Bilateral Lower Extremity Motor Function as a Key Predictor.

PURPOSE: In many individuals with spinal cord injury a return of volitional bladder voiding is considered more important than regaining motor function. Recently a predictive model using only composite bilateral lower extremity motor scores for levels L2-S1 (range 0 to 50) was proposed by the EMSCI (European Multicenter Study about Spinal Cord Injury) group. The model showed exceptional predictive power with an AUC of 0.912. We sought to further validate the EMSCI model in a national spinal cord injury cohort. MATERIALS AND METHODS: We created models of volitional voiding using the United States NSCID (National Spinal Cord Injury Database) for 2007 to 2016. In addition to testing lower extremity motor scores, we evaluated other patient variables that we hypothesized might affect volitional voiding. RESULTS: Volitional voiding was present in 1,333 of the cohort of 4,327 individuals (30.8%) at 1-year followup. While younger age, female gender, increased sacral sparing, improved AIS (American Spinal Injury Association Impairment Scale) classification and a more caudal sensory level predicted volitional voiding, lower extremity motor scores were most predictive (AUC 0.919). Adding the other patient characteristics did little to improve model performance (full model AUC 0.932). Further analysis of the predictive power of lower extremity motor scores suggested that while the AUC appeared to decrease in persons who were most likely to void volitionally, the performance of the predictive model remained outstanding with a combined AIS C and D AUC of 0.792. CONCLUSIONS: Our study verifies the validity of the EMSCI predictive model of volitional voiding after spinal cord injury. The differing performance of lower extremity motor scores in various AIS classifications should be noted.

Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation.

PURPOSE: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. MATERIALS AND METHODS: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. RESULTS: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60-74) using modified completers analysis and 82% (95% CI 76-88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). CONCLUSIONS: This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.

The cost of a catheter: An environmental perspective on single use clean intermittent catheterization.

METHODS: We estimated the prevalence of CIC use in the United States using a neurogenic population, consisting of persons with multiple sclerosis, spina bifida, and spinal cord injury. We measured catheter samples to obtain the amount of waste per catheter. RESULTS: At least 300 800 persons in the United States perform CIC for neurogenic bladder management. Assuming five catheterization events per day, the amount of waste generated by single-use CIC is between 26 500 to 235 400 pounds or 22 600 to 564 000 liters per day, depending on catheter model. CONCLUSIONS: Single-use CIC may generate up to 85 million pounds or 206 million liters of waste annually, equivalent to more than 26 000 cars or 80 Olympic-sized swimming pools. Laid end-to-end, there is enough catheter length circumscribe the world more than 5.5 times. The most common materials used in catheter construction have little to no degradation once in a landfill. Given the unproven clinical benefit of single-use catheterization, the environmental impact and alternatives should be considered.

A Systematic Approach to the Evaluation and Management of the Failed Artificial Urinary Sphincter.

In men with post-prostatectomy incontinence, persistent or recurrent urinary leakage following artificial urinary sphincter placement is a frustrating complaint. Surgical failure can be classified as occurring early in the post-operative period vs. late-following a period of established continence-and should be managed according to the time course and severity of urinary leakage. We present a systematic approach for the evaluation and treatment of the failed artificial urinary sphincter. After considering the patient's individualized treatment goals and impact on quality of life, the clinician can more appropriately advise patients on a management strategy for their recurrent or persistent urinary incontinence following artificial urinary sphincter placement.

Urodynamics of men with urinary retention.

OBJECTIVES: To describe the urodynamic characteristics of men with urinary retention, and to show the diverse treatment plans based on urodynamic findings. METHODS: We carried out a 3-year retrospective review of men with urinary retention who were referred to our clinic for urodynamic evaluation. Men with a history of neurogenic voiding dysfunction or major pelvic surgery were excluded. Multichannel videourodynamic studies were carried out, and the subsequent treatment modality offered was recorded. RESULTS: A total of 67 men with urinary retention and a median age of 68 years underwent urodynamic evaluation. The median maximum flow rate was 3 mL/s, and the median detrusor pressure at maximum flow was 54 cm H2 O. Bladder outlet obstruction was diagnosed in 60%. Detrusor underactivity was present in 73% according to the bladder contractility index; however, just 29% were classified as having detrusor underactivity according to isometric detrusor pressure, an alternative measure of contractility. A total of 76% of patients had low detrusor reserve (<20 cm H2 O). Based on urodynamic findings, just 57% of patients were offered de-obstructive surgery. CONCLUSIONS: In the present cohort, just 60% of men with urinary retention showed urodynamic evidence of bladder outlet obstruction. Depending on how contractility is measured (bladder contractility index vs isometric detrusor pressure), the rate of detrusor underactivity varies. The majority of men with retention had a low detrusor reserve. Given the wide spectrum of urodynamic findings in men with retention, surgical intervention might not be necessary for all. Furthermore, a careful consideration of urodynamics can assist in the selection of optimal treatment.

Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder.

AIMS: This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included. METHODS: Subjects with successful test stimulation received an SNM implant. Therapeutic success (≥50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects. RESULTS: Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1 ± 2.7 leaks/day, UF subjects had 12.6 ± 4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2 ± 2.7 leaks/day; UF subjects had a mean reduction of 5.1 ± 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant. CONCLUSIONS: This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications.

Chronic sacral nerve stimulation as a novel treatment for stress urinary incontinence-A rat model.

AIMS: We propose an animal model to evaluate the effect of chronic sacral nerve stimulation (SNS) on surgically induced intrinsic sphincter deficiency (ISD) secondary to transabdominal urethrolysis (U-Lys). METHODS: Twenty-five 6-week old virgin female Sprague-Dawley rats were divided into four groups: control (CTRL), U-Lys only, SNS only, and both (U-Lys/SNS). Groups CTRL (N = 5) and U-Lys only (N = 5) were maintained in the animal research facility in standard fashion for 2 weeks. Groups SNS only (N = 5) and U-Lys/SNS (N = 10) underwent chronic SNS for 6 continuous hours daily for 2 weeks. Retrograde leak point pressure (RLPP) was measured at baseline and at 2 weeks following observation or treatment. Five consecutive RLPP measurements were averaged per measurement cycle. SAS 9.3 was used to evaluate means and standard deviation. RESULTS: Baseline mean RLPP was 65 mmHg. The U-Lys only group mean RLPP at initial urethrolysis (58 mmHg) decreased (31 mmHg, P < 0.0001) after 2 weeks of observation. In the SNS only group, mean RLPP significantly increased from baseline (73 mmHg) after 2 weeks of chronic SNS stimulation (80 mmHg, P < 0.01). In rats that underwent both U-Lys and SNS stimulation mean RLPP was initially low (46 mmHg) after U-Lys and then significantly increased after 2 weeks of SNS (65 mmHg, P < 0.0001). CONCLUSION: Chronic SNS mediates an improvement in urethral sphincteric function at stimulation parameters similar to those used in humans for treating voiding dysfunction. SNS increased urethral resistance in rats with and without surgically induced ISD.

Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder.

AIMS: This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). METHODS: Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (≥2 leaks/72 hr) and/or urgency-frequency (≥8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. RESULTS: Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. CONCLUSIONS: This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. © 2014 Wiley Periodicals, Inc.