Effect of pulse width variations on sacral neuromodulation for overactive bladder symptoms: A prospective randomized crossover feasibility study.

INTRODUCTION/BACKGROUND: The pulse width (PW) parameter in sacral neuromodulation (SNM) is understudied, with no evidence-based guidance available on optimal PW for urinary indications. The aim of this prospective, randomized, single-blinded, 3 × 3 cross over design study was to estimate the effect of two PW settings (60 µs, 420 µs) compared to the industry standard (210 µs) on SNM efficacy, quality of life, and device parameters in patients who were stable and satisfied with their SNM treatment. METHODS/MATERIALS: Eligible patients were previously implanted and had urge incontinence or urgency-frequency with satisfaction on SNM at time of enrollment. Patients completed a 3-day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4-week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis. RESULTS: Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment -2.23 voids/day (p = 0.015). Upon sub-analysis, patients reporting "much better" or "very much better" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting "much better" or "very much better" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications. CONCLUSIONS: Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy.

Telemedicine follow-up is safe and efficacious for synthetic midurethral slings: a randomized, multi-institutional control trial.

INTRODUCTION AND HYPOTHESIS: The objective was to assess whether telemedicine-based follow-up is equivalent to office-based follow-up in the early postoperative period after routine synthetic midurethral sling placement. METHODS: This is a prospective, international, multi-institutional, randomized controlled trial. Patients undergoing synthetic midurethral sling placement were randomized to 3-week postoperative telemedicine versus office-based follow-up. The primary outcome was the rate of unplanned events. Secondary outcomes included patient satisfaction, crossover from telemedicine to office-based follow-up, and compliance with 3- to 5-month office follow-up. RESULTS: We included 238 patients (telemedicine: 121 vs office: 117). No differences in demographics or medical comorbidities were noted between the study groups (p = 0.09-1.0). No differences were noted in unplanned events: hospital admission, emergency department visit, or unplanned office visit or call (14% vs 12.9%, p = 0.85) or complications (9.9% vs 8.6%, p = 0.82). Both groups were equally "very satisfied" with their surgical outcomes (71.1% vs 69%, p = 0.2). Telemedicine patients were more compliant with 3- to 5-month office follow-up (90.1% vs 79.3%, p = 0.04). CONCLUSIONS: After synthetic midurethral sling placement, telemedicine follow-up is a safe patient communication option in the early postoperative period. Telemedicine patients reported no difference in satisfaction compared with office-based follow-up but had greater compliance with 3- to 5-month follow-up.

The role of pulse width manipulation compared to program changes alone for unsatisfactory sacral neuromodulation therapy: A retrospective matched-cohort analysis.

AIM: Pulse width (PW) influences neuromodulation by its impact on nerve fiber recruitment. A paucity of data regarding the manipulation of PW in sacral neuromodulation (SNM) exists. This study describes the clinical features and outcomes of PW manipulation for unsatisfactory SNM therapy. METHODS: A retrospective, single-institution review was performed of reprogrammed SNM patients between 2010 and 2019. Two cohorts were created: those with PW changes ± program changes and age-matched controls with program changes alone. Patients lacking follow-up and non-InterStim II models were excluded. RESULTS: Out of 710 SNM interrogations, 147 (20.7%) had PW changes and 80 met inclusion criteria. Most PW changes were shortened (61/80, 76.3%). Clinical features did not differ between cohorts except by indication for reprogramming. The most common indication for PW change was painful stimulation (34/80, 43%), whereas in controls it was suboptimal efficacy (76/80, 95%). Clinical success was stratified by indication. There was a higher improvement in efficacy in the PW cohort (61%, 17/28 vs. 36%, 27/76, p = .02). PW manipulation successfully relieved painful stimulation in 50% (17/34 vs. 0/3, p = .23), which was more likely with a shortened compared to extended PW (14/15, 93.3% vs. 0/6, 0%, p < .01). PW resulted in improvement in localization of the stimulus in 94% (17/18 vs. 0/1, p = .10). The subsequent lead revision or explant was significantly higher in the PW cohort (43% vs. 25%, p = .03). CONCLUSION: PW manipulation may aid the salvage of unsatisfactory SNM therapy. These findings represent an initial assessment of the role of PW in SNM, particularly regarding the efficacy and painful stimuli. The further prospective investigation is warranted.

Predictive factors of PNE success in a contemporary series: A single institution experience.

PURPOSE: Peripheral nerve evaluation (PNE) permits a trial of sacral neuromodulation to determine candidates for single stage implant. Before routine fluoroscopy, PNE success rates were 40%-50% compared to approximately 77% with staged procedures. There are limited data on PNE success rates with the use of fluoroscopy and improved techniques. We evaluated a contemporary series of PNE patients to determine predictors of PNE success and persistent functional response following permanent implantation. METHODS: A retrospective review of PNE patients at a large academic center from 2015 to 2019 was performed. Patients with urgency-frequency, urge incontinence, and/or fecal incontinence (FI) were included. Rates of permanent implant after successful PNE trial and continued improvement at ≥1 month were reviewed. Multivariable logistic regression determined predictors of PNE success and continued response at follow-up. RESULTS: A total of 102 PNE patients were included. A total of 78 patients (76.5%) were PNE responders. Predictors of PNE success included younger age (p = .014), urgency incontinence (p = .021), FI (p = .017), absence of a neurologic diagnosis (p = .04), presence of bellows and toe responses (p = .038), and perineal sensation (p = .027). A total of 68 of 78 PNE responders (87.2%) maintained optimal responses at ≥1 month. Absence of a neurologic diagnosis was predictive of persistent success at follow-up (p = .013). CONCLUSIONS: This contemporary PNE series revealed screening success equivalent to a two-staged approach. A small proportion of patients demonstrate suboptimal responses following permanent implant. Conversion from testing to permanent implant may not be the ideal outcome as it may overestimate success, and evaluation for persistent improvement should be investigated further as a more reliable indicator of successful screening.

Blinded Comparison of Clarity, Proficiency and Diagnostic Capability of Tele-Cystoscopy Compared to Traditional Cystoscopy: A Pilot Study.

PURPOSE: In order to expand the availability of cystoscopy to underserved areas we have proposed using advanced practice providers to perform cystoscopy with real-time interpretation by the urologist on a telemedicine platform, termed "tele-cystoscopy." The purpose of this study is to have blinded external reviewers retrospectively compare multisite, prospectively collected video data from tele-cystoscopy with the video of traditional cystoscopy in terms of video clarity, practitioner proficiency and diagnostic capability. MATERIALS AND METHODS: Each patient underwent tele-cystoscopy by a trained advanced practice provider and traditional cystoscopy with an onsite urologist. Prospectively collected tele-cystoscopy transmitted video, tele-cystoscopy onsite video and traditional cystoscopy video were de-identified and blinded to external reviewers. Each video was evaluated and rated twice by independent reviewers and diagnostic agreement was quantified. RESULTS: Six tele-cystoscopy encounters were reviewed for a total of 36 assessments. Video clarity, defined by speed of transmission and image resolution, was better for onsite compared to transmitted tele-cystoscopy. Practitioner proficiency for thoroughness of inspection was rated at 92% for tele-cystoscopy and 100% for traditional cystoscopy. Confidence in identification of an abnormality was equivalent. Four of 6 videos had 100% agreement between reviewers for next action taken, indicating high diagnostic agreement. Additionally, provider performing cystoscopy and location did not statistically influence the ability to make a diagnosis or action taken. CONCLUSIONS: This model has excellent completeness of examination, equivalent ability to identify abnormalities and external validation of action taken. This pilot study demonstrates that tele-cystoscopy may expand access to bladder cancer surveillance.

17-Year Single Center Retrospective Review of Rate, Risk Factors and Outcomes of Lead Breakage during Sacral Neuromodulation Lead Removal.

PURPOSE: One risk of removal of a tined sacral neuromodulation lead is breakage, resulting in a retained lead fragment. We report lead breakage rates, risk factors and outcomes of retained fragments. MATERIALS AND METHODS: We report on 464 tined lead removals from 2002 to 2018. Clinical and surgical factors were reviewed and appropriate statistical analysis performed. Retained fragments were reviewed for fragment description and long-term complications. RESULTS: A total of 464 tined lead removals were included, with 35 lead breaks identified, for a rate of 7.5% (35). Factors associated with breakage included male gender (OR 6.58, 95% CI 2.54-17.01, p=0.001) and diabetes (OR 2.42, 95% CI 1.05-5.58, p=0.019). A shorter time since implantation was protective (OR 0.86, 95% CI 0.76-0.98, p=0.002). There was no difference in breakage rate based on age, weight, history of prior revision, bilateral leads, reason for lead removal, surgical technique or surgeon. Of the 35 breaks 27 had imaging available. Of these 66% (18) broke in the tined region and 81% (22) were ghost leads. Most patients (80%, 28 of 35) with retained lead fragments received another implant. Only 1 patient had a related complication of additional surgery for pain related to the fragment. CONCLUSIONS: There is a low rate of tined lead breakage during lead removal. However, it is higher than the manufacturer estimate. Protective factors include a shorter time between implant and lead revision. The most common location for lead breakage is in the region of the tines, most are ghost fragments and long-term complications are uncommon.

Safety of Intradetrusor OnabotulinumtoxinA (BTX-A) Injection in the Asymptomatic Patient With a Positive Urine Dip.

OBJECTIVE: To evaluate differences in adverse events (AE) in asymptomatic patients with a positive urine dip (UD) at time of intradetrusor onabotulinumtoxinA (BTX-A) injection vsthose with a defined negative UD. MATERIALS AND METHODS: All intradetrusor BTX-A injections were retrospectively reviewed at a single institution between 2016 and 2018. Exclusion criteria included an indwelling catheter, recent positive urine culture, recent antibiotic course, or absence of UD on the day of injection. A positive UD was defined using 7 different definitions with varying combinations of any level of positive blood, leukocyte esterase, or nitrite. Negative UDs were defined those excluded from the positive UD group. We compared multiple positive UD-defined groups to their respective negative UD cohorts with regards to outcomes and demographics. RESULTS: A total of 212 patients underwent 335 cycles of BTX-A injections over a 2-year period. The average age was 65 years (range: 21-90). The majority received 100 units (73%) of BTX-A for a non-neurogenic diagnosis (73%). The overall rate of AEs, urinary tract infection, and urinary retention was 14.6%, 9%, and 3%, respectively. In all groups, the most common AE was urinary tract infection followed by urinary retention. There were no major Clavien-Dindo-defined complications. There was no statistically significant difference in the total or categorical AE rates between positive and negative UD groups using all 7 definitions of a positive UD (P = .05-1.0). CONCLUSION: These data do not support the practice of obtaining a preprocedure UD in asymptomatic patients undergoing intradetrusor BTX-A injection for any indication; test results are unable to predict outcomes or AEs.

What Is New in Neuromodulation?

Neuromodulation encompassing sacral and peripheral modalities is an established, effective, and safe higher-order treatment option approved in the USA for managing refractory overactive bladder, non-obstructive urinary retention, and fecal incontinence. This review highlights the most recent literature, indications, treatment durability, and the latest innovations in this field. Regarding sacral neuromodulation (SNM), recent work suggests improved parameters for optimal lead placement, increased data to support the lasting effects of treatment, and novel applications of this technology to other pelvic disorders. In addition, there are emerging technologies with smaller MRI compatible devices. Newer data on percutaneous tibial nerve stimulation (PTNS) suggests it may be more beneficial for certain patients. With new technology, implantable tibial nerve stimulators are ushering in a new frontier of nerve stimulation in the comfort of the patient's home.