Percutaneous Nerve Evaluation Research Articles

Patient Satisfaction With Long-term Sacral Neuromodulation for Fecal Incontinence: Experience from a Single Tertiary Center.

Sacral Neuromodulation is an effective treatment for faecal incontinence in the long-term. Efficacy is typically assessed using bowel diary, symptom severity, or quality of life questionnaires and 'success' defined as >50% improvement in these measures. Patient satisfaction may however be a more meaningful and individualised measure of treatment efficacy. To assess patient reported satisfaction with long-term sacral neuromodulation and compare it to the frequently applied efficacy measures. An observational study of a prospectively maintained database. A single tertiary pelvic floor referral unit. Data from 70 (68 female, median age 69 [60 - 74]) patients were available. The median time since implantation was 11 (9 - 14) years. Nineteen patients reported inactive neuromodulation devices. Bowel diaries, the Manchester Health Questionnaire, and the St Marks Incontinence Score recorded at baseline, after percutaneous nerve evaluation, and at last follow-up. Patient reported satisfaction, using a 0%-100% visual analogue scale, with treatment since implantation (overall) and in the two-weeks preceding completion of the last outcome measures (current). Satisfaction was significantly higher in those with active sacral neuromodulation devices (75% vs 20%, p<0.001) at follow-up. No significant relationships exist between symptom improvement using conventional measures, and patient reported satisfaction. Current satisfaction was not associated with changes in bowel diary data following percutaneous nerve evaluation. Despite improvements in the St Mark's incontinence score and Manchester Health Questionnaire below the 50% improvement threshold used to define 'success', patients reported high (80%) satisfaction. Retrospective with gaps in the available data. High patient satisfaction with sacral neuromodulation can be achieved, however the response to percutaneous nerve evaluation may not predict treatment satisfaction in long-term. The change in questionnaire results, which measure the use of compensatory behaviors and quality of life impact, may better correspond to treatment satisfaction.

Sacral neuromodulation in nursing home residents: Predictors of success and complications in a national cohort of older adults.

There is limited evidence to support the efficacy of sacral neuromodulation (SNM) for older adults with overactive bladder (OAB). This study aims to report outcomes following SNM among nursing home (NH) residents, a vulnerable population with high rates of frailty and comorbidity. This is a retrospective cohort study of long-stay NH residents who underwent a trial of percutaneous nerve evaluation (PNE) or Stage 1 permanent lead placement (Stage 1) between 2014 and 2016. Residents were identified using the Minimum Data Set linked to Medicare claims. The primary outcome of this study was successful progression from trial to implant. Rates of 1-year device explant/revisions were also investigated. Trial of SNM was observed in 1089 residents (mean age: 77.9 years). PNE was performed in 66.9% of residents and 33.2% underwent Stage 1. Of Stage 1 procedures, 23.8% were performed with simultaneous device implant (single-stage). Overall, 53.1% of PNEs and 72.4% of Stage 1 progressed to device implant, which was associated with Stage 1 procedure versus PNE (adjusted relative risk [aRR]: 1.34; 95% confidence interval [95% CI]: 1.21-1.49) and female versus male sex (aRR: 1.26; 95% CI: 1.09-1.46). One-year explant/revision was observed in 9.3% of residents (6.3% for PNE, 10.5% for Stage 1, 20.3% single-stage). Single stage procedure versus PNE was significantly associated with device explant/revision (aRR: 3.4; 95% CI: 1.9-6.2). In this large cohort of NH residents, outcomes following SNM were similar to previous reports of younger healthier cohorts. Surgeons managing older patients with OAB should use caution when selecting patients for single stage SNM procedures.

Long-term cost-effectiveness analysis of sacral neuromodulation in the treatment of severe faecal incontinence.

The aim of this study was to evaluate the long-term cost-effectiveness of sacral neuromodulation in the treatment of severe faecal incontinence as compared with symptomatic management. In the public health field, a micro-costing evaluation method was conducted from the perspectives of the health system and the society. The incremental cost-effectiveness ratio was used as a decision index, and we considered various scenarios to evaluate the impact of the cost of symptomatic management and percutaneous nerve evaluation success rate in its calculation. Clinical data were retrieved from a consecutive cohort of 93 patients with severe faecal incontinence undergoing sacral neuromodulation after a failure of conservative (pharmacological and biofeedback) and/or surgical (sphincteroplasty) first-line treatments were considered. The long-term incremental cost-effectiveness ratio comparing sacral neuromodulation versus symptomatic management was 14347€/QALY and 28523€/QALY from the societal and health service provider's perspectives, respectively. If the definitive pulse generator implant success rate was 100%, incremental cost-effectiveness would correspond to 6831€/QALY and 16761€/QALY, respectively. Sacral neuromodulation may be considered a cost-effective technique in the long-term treatment of severe faecal incontinence from the societal and health care sector perspectives. Improving patient selection and determining the predictive outcome factors for successful sacral neuromodulation in the treatment of faecal incontinence would improve cost-effectiveness.

Design, implementation and assessment of a novel, introductory curriculum into female, neurological and urodynamic urology: a 7-year experience of urology simulation bootcamp course.

To present the seven-year experience of a multi-component and interactive module on female, neurological and urodynamic urology (FNUU) training at the UK National Urology Simulation Bootcamp Course (USBC) and demonstrate trainee satisfaction and competency progression. During the week-long USBC, a four-hour module on FNUU was designed which consisted of short interactive presentations with an emphasis on practical stations in urodynamics, intravesical botulinum toxin injection, urethral bulking injection, female pelvic examination and, initially, mid-urethral tapes (subsequently replaced with percutaneous sacral nerve evaluation). The trainee's level of knowledge, operative experience and confidence were assessed pre- and post-course. The practical assessment consisted of preparation and intravesical administration of botulinum toxin, female pelvic examination, urodynamic trace interpretation or mid-urethral tape simulation. Trainee feedback was also collected. Two-hundred sixty-one newly appointed urology trainees participated in the USBC during this period. A high level of satisfaction was constantly reported. The highest rated session was urethral bulking with 72% being very satisfied, followed by Botox and urodynamics. The final assessment showed 70% had achieved level 4 competency in cystoscopy and Botox. Qualitative feedback was also obtained. To our knowledge, this is the first module of its kind, and it shows that it is feasible to develop, implement and evaluate an introductory curriculum into FNUU that is reproducible over a 7-year period with very positive feedback.

Data Gap in Sacral Neuromodulation Documentation: Call to Improve Documentation Protocols

PurposeWe quantified patient record documentation of sacral neuromodulation (SNM) threshold testing and programming parameters at our institution to identify opportunities to improve therapy outcomes and future SNM technologies.MethodsA retrospective review was conducted using 127 records from 40 SNM patients. Records were screened for SNM documentation including qualitative and quantitative data. The qualitative covered indirect references to threshold testing and the quantitative included efficacy descriptions and device programming used by the patient. Findings were categorized by visit type: percutaneous nerve evaluation (PNE), stage 1 (S1), permanent lead implantation, stage 2 (S2) permanent impulse generator implantation, device-related follow-up, or surgical removal.ResultsDocumentation of threshold testing was more complete during initial implant visits (PNE and S1), less complete for S2 visits, and infrequent for follow-up clinical visits. Surgical motor thresholds were most often referred to using only qualitative comments such as “good response” (88%, 100% for PNE, S1) and less commonly included quantitative values (68%, 84%), locations of response (84%, 83%) or specific contacts used for testing (0%). S2 motor thresholds were less well documented with qualitative, quantitative, and anatomical location outcomes at 70%, 48%, and 36% respectively. Surgical notes did not include specific stimulation parameters or contacts used for tests. Postoperative sensory tests were often only qualitative (80%, 67% for PNE, S1) with quantitative values documented much less frequently (39%, 9%) and typically lacked sensory locations or electrode-specific results. For follow-up visits, <10% included quantitative sensory test outcomes. Few records (<7%) included device program settings recommended for therapy delivery and none included therapy-use logs.ConclusionsWhile evidence suggests contact and parameter-specific programming can improve SNM therapy outcomes, there is a major gap in the documentation of this data. More detailed testing and documentation could improve therapeutic options for parameter titration and provide design inputs for future technologies.

Novel electrode design reduces sensory threshold current drift during peripheral nerve evaluation in patients considered for sacral nerve stimulation

Objective: To retrospectively compare the efficacy and technical performance of a novel lead used for percutaneous nerve evaluation (PNE) during the testing phase for sacral nerve neuromodulation with the existing lead currently used. Materials and methods: Sixty-three PNE leads were inserted in 45 consecutive patients who underwent PNE with the novel helical electrodes, and the intra-operative and return clinic sensory threshold currents were recorded. This resulted in current measurements for 63 individual electrodes. Measurements were compared with 46 consecutive patients who previously underwent PNE using the standard lead with measurements for 63 individual electrodes. Current difference distributions for the two leads were compared using a Wilcoxon signed-rank test. Results: There was a statistically significant difference observed between the two types of PNE electrode. The new PNE lead demonstrated less drift in sensory threshold current during a 12-day test period in comparison to the old lead. Conclusion: The novel helical PNE electrodes demonstrate a significant improvement in current drift compared with the old style leads over a 12-day test period. Level of evidence: Level III

Sacral neuromodulation in patients with detrusor underactivity: Is biological sex an indicator?

This study aimed to report sacral neuromodulation (SNM) outcomes in detrusor underactivity (DU). A multicentric, multinational, retrospective case series was conducted between March 2017 and June 2021 in three different referral centers. Initial test phase stimulation included either a percutaneous nerve evaluation (PNE) or an advanced lead evaluation test phase (ALTP) before permanent SNM implantation. The test phases were performed under local anesthesia, either in the outpatient (PNE) or operating room (ALTP), in the prone position, which was implanted in the third or fourth sacral foramina under fluoroscopic guidance. Patients with favorable response to the initial test phase during the first 2 weeks underwent the implantable pulse generator (IPG) implantation (Medtronic neurostimulation generator device InterStim™). Favorable response was defined as ≥ 50% improvement in symptoms, frequency of clean intermittent catheterization (CIC) and/or decrease in postvoid residual (PVR), increase in voided volume, or improvement in bladder voiding efficiency (BVE) based on the bladder diary. Fifty-eight patients were recruited with a mean age of 39.95 ± 15.28 years. Among the 58 cases, 36 (62.1%) patients responded to the initial stage. Of these, 12 patients (30.8%) with non-neurogenic etiology and nine patients (52.9%) with neurologic etiology did not respond to the initial test phase; thus, they did not undergo full implantation (p = 0.141). Voided volume, PVR, and the median maximum flow rate (Qmax) improved significantly (p < 0.001) in both sexes; however, there was no statistical difference between both genders. Most female cases (78.3%), and nearly half of the men (51.4%), responded to the test phase and were candidates for the IPG phase. Among the 35 cases who underwent IPG, 27 patients (72.2% of males, and 77.8% of females; p = 0.700) had a favorable response to IPG. 46.6% of patients had a successful outcome at the end of the study. This multicentric study showed that SNM effectively and safely provided symptom improvement in refractory DU in males similar to females which is an important finding as previously it has been suggested that SNM works better in nonobstructive urinary retention in women and not in women.

Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects

ABSTRACT Introduction Sacral Neuromodulation (SNM) is a minimally invasive treatment for OAB patients following failure of conventional interventions. Patient selection, lead placement, and testing technique are important pillars in optimizing success rates. Areas covered A comprehensive literature search was conducted on ‘sacral neuromodulation’ and ‘overactive bladder.’ There was no date restriction, with the last search dated 31 May 2021. Patient selection, lead placement, test phases, safety, efficacy, and available devices are thoroughly discussedLastly, future perspectives will be presented with the anticipated trajectory of sacral neuromodulation over the next five years. Expert opinion/commentary SNM has proved to be a safe and effective therapy on the short-, medium- and long-term without precluding any other treatment options. In all studies reviewed, no life threatening or major irreversible complications were presented. However, surgical re-intervention rates were high with a median of 33.2% (range: 8–34%) in studies with at least 24 months follow-up. No true consensus could be made regarding prognostic factors. However, optimized lead placement, consequent ideal motor thresholds, and the use of a curved stylet theoretically facilitates reaching maximal success with SNM. Test phase success rates increased to such a level that from a cost-effective point of view, single-stage implants could be considered. Abbreviations: OAB: overactive bladder; SNM: sacral neuromodulation; BoNT-A: Botulinum toxin A; PFM EMG: pelvic floor muscle electromyography; IPG: implantable pulse generator; PNE: percutaneous nerve evaluation; FSTLP: first-stage tined lead procedure; NLUTD: neurogenic lower urinary tract dysfunction; ITT: intention to threat; PPMC: per protocol modified completers; PPC: per protocol completers; AE: adverse event; MRI: magnetic resonance imaging; RCT: randomized controlled trial

Mid-term efficacy of sacral nerve stimulation for the treatment of chronic constipation

Objective: To investigate the mid-term efficacy of sacral nerve stimulation (SNS) for chronic constipation. Methods: A descriptive case series study was conducted. Patients with chronic constipation were treated in Xijing Hospital of Digestive Disease from February 2013 to December 2018 were retrospectively enrolled. The types of constipation were confirmed based on colon slow transit test, anorectal manometry and defecography in Xi'an Mayinglong Coloproctological Hospital. This study has been registered in China clinical trial registry (Registration No.: ChiCTR-ROC-16008945). Case inclusion criteria: (1) constipation was diagnosed according to Rome III criteria; (2) traditional treatment, including education, diet adjustment, laxative, biofeedback treatment, failed for at least 1 year; (3) there were no constipation-related organic diseases. After excluding neurogenic diseases, including spinal cord injury and multiple sclerosis, 21 patients were included in this study. There were 10 males and 11 females, with an average age of 50.9 (14-76) years. After the relevant examination and evaluation of patients, they underwent percutaneous nerve evaluation (PNE). If patient experienced a good response to PNE after 2 or 3 weeks (≥50%), permanent SNS implantation was performed. The improvement of clinical symptoms and quality of life between the baseline, PNE, and latest follow-up time points were compared. Improvement of clinical symptoms, including autonomic stool frequency per week, autonomic stool days per week, defecation time, visual analogue scale (VAS, lower score indicates more serious symptoms) score and Cleveland clinic constipation score (CCCS, higher score indacates more serious symptoms) criteria. The change of quality of life was scored by SF-36 questionnaires (the higher score indicates better quality of life). Results: Of 21 patients, 18 (85.7%) experienced significant improvement in symptoms with PNE, and 2 patients discontinued treatment due to their dissatisfaction. Sixteen patients (76.2%) received permanent SNS implantation, two of whom underwent bilateral PNE implantation. These patients were followed-up for mean 56 (34-72) months. The treatment was continuously effective in 13 patients (61.9%), including 3 of ODS, 1 of STC and 9 of mixed constipation. Compared with baseline, the score of constipation patients receiving permanent SNS implantation at latest follow-up was shown. The median autonomic stool frequency per week increased from 1.0 (0-7) to 7.5 (0-10) (P<0.001), the median autonomic stool days per week increased from 1.0 (0-7) d to 4.5 (0-7) d (P<0.001), the median defecation time decreased from 19.0 (8-40) minutes to 4.0 (3-31) minutes (P<0.001), the median CCCS decreased from 20.0 (13-30) to 9.0 (6-30) (P<0.001), and the median VAS score increased from 9.0 (7-40) to 80.0 (15-90) (P<0.001). The values of the 8 parts of the SF-36 questionnaire increased (all P<0.05). Conclusion: SNS implantation is safe and has obvious effects on severe constipation with stable mid-term efficacy.

Sacral nerve stimulation for the treatment of severe fecal incontinence: long-term quality of life and functional outcomes

The aim is to determine whether good functional and quality of life results of sacral nerve stimulation (SNS) in patients with severe fecal incontinence are maintained in the long-term. Consecutive cohort of patients with severe fecal incontinence not responding to conservative (drugs and/or biofeedback) or surgical (sphincteroplasty) treatment, undergoing SNS between 2002 and 2013. Patients with a definitive implant were individually assessed in consultation throughout the follow-up, until January 2016. Defeca-tory function was assessed by Wexner score and stool diary, and perceived quality of life by FIQL and EQ-5D question-naires. Acute percutaneous nerve evaluation (PNE) was performed on 93 patients; a temporary electrode was implanted in 91 (79.1% women, mean age 62.5 years), obtaining a good functional response in 64. A permanent implant was per-formed in 61 patients, with a mean follow-up of 78.1 months (SD: 35.4; range 1-161); at the end of the study 42 patients remained in follow-up. A significant decrease was observed in the number of days per week with an incontinent episode, from 4.98 (SD 2.1) to 1.25 (SD 1.7), and in Wexner score from 16.88 (SD 2.74) to 6.95 (SD 3.54). Specific FIQL and generic EQ-5D questionnaires showed a significant improvement in quality of life. Long-term functional and quality of life outcomes of SNS for the treatment of severe faecal incontinence is maintained, with individual follow-ups that reach 10 years.

The Impact of Fluoroscopy During Percutaneous Nerve Evaluation on Subsequent Implantation of a Sacral Neuromodulator Among Women With Pelvic Floor Disorders: A Randomized, Noninferiority Trial

To evaluate whether percutaneous nerve evaluation (PNE) without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation (SNM) for pelvic floor disorders (PFDs). In an unblinded noninferiority trial, women undergoing PNE were randomized to fluoroscopy or no fluoroscopy. The primary outcome was "success" and defined as implantation of the permanent SNM device within three months of PNE. At an expected 40% success and a 30% noninferiority threshold, 33 participants in each group were needed for 80% power (α = 0.05). Univariate analyses and a logistic regression model adjusting for univariate variables associated with the primary outcome were performed. From April 2016 to December 2018, 74 participants underwent PNE of which 36 underwent PNE with fluoroscopy and 38 without. The fluoroscopy group had less baseline mean daily voids compared to the no fluoroscopy group (10.79 ± 6.48 vs. 16.21 ± 10.05, p = 0.01). PNE performed without fluoroscopy had similar success (18/38, 47.4%) compared to fluoroscopy (21/36, 58.3%), meeting our noninferiority definition (difference 10.9%, 90% CI -8% to 30%, p = 0.049). In a logistic regression model adjusting for age, Charlson comorbidity index, stage of prolapse, and number of baseline voids per day, trial success was still similar between the two groups (adjOR 1.82, 95% CI 0.52 to 6.94, p = 0.36). PNE performed without fluoroscopy is noninferior to PNE with fluoroscopy use for the outcome of SNM device implantation within three months among women undergoing therapy for PFDs.

Short- and Long-term Effectiveness of Sacral Nerve Stimulation in Patients with Overactive Bladder

BACKGROUND: Sacral nerve stimulation (SNS) approved for use in North America since 1997 despite the fact that the concept of using SNS to treat patients with voiding dysfunction discussed first almost 50 years ago.&#x0D; AIM: The objectives of the study were to assess the effectiveness of SNS the short and long term for patients with overactive bladder (OAB) dysfunction and its relation to age, gender, and causes.&#x0D; PATIENTS AND METHODS: This is a clinical prospective study that involved 50 cases (32 females and 18 males) with OAB. It was carried out at Ibn Sina Hospital, and the neurosciences hospital in Baghdad/Iraq from April 2015 to April 2018. All the patients were assessed preoperatively and certain inclusion criteria were used. The patients went through the 2 stage implantations of the Medtronic InterStim®. The patients were assessed at 6 months (short term) and 2 years (long term) postoperatively.&#x0D; RESULTS: The results of our patients were analyzed with respect to age, gender, causes of OAB, and post-operative complications. We found that younger age patients, female patients, and patients with neurogenic causes of OAB showed a better response in both the short- and long-term follow-up.&#x0D; CONCLUSION: Considerable progress has been made in the surgical management of OAB. Proper selection of patients is the key to the success of SNS, and female patients have better results compared to male patients. Furthermore, younger patients and patients with neurogenic causes did better than older patients and patients with idiopathic causes. SNS is a safe minimally invasive surgery with a low complication rate, and the 2 stages procedure has better results than the percutaneous nerve evaluation.

A Cadaveric Study on the Efficacy of Surface Marking and Bony Landmarks Used in Sacral Neuromodulation.

BackgroundAnatomical landmarks and surface markings have long been used in out-patient contexts for conducting percutaneous nerve evaluation procedures, but studies testing the reliability of these anatomical landmarks are scant. There have been reports where the procedure has failed. Could it be possible that the anatomical landmarks that are used are not reliable enough? To answer this question, we used this study to understand the reliability of these anatomical landmarks.MethodsTwenty cadavers, 10 males and 10 females, were dissected in the sacral region; the landmarks were tested, and the angulation and curve made by the sacral 3 (S3) nerve were also studied.ResultsSacral 3 was identified mainly at the four o’clock position on the right and at the eight o’clock position on the left side. The Sacral 3 foramen was found at a mean distance of 9.17 ± 0.23 cm from the tip of the coccyx. The mean distance of the lateral margin of S3 from the median sacral ridge was found to be 2.16 ± 0.07 cm.Conclusion The landmark of 9 cm from the coccyx tip is a valid landmark for sacral neuromodulation (SNM) procedures. The tip of the lead should follow the curve of the nerve as close as possible at the four and eight o’clock positions on the right and left side, respectively. However, the length of the coccyx differs from person to person. The proximity of the adjacent foramina to each other and the variations in the emerging of the nerve are a few factors to be considered while performing SNM procedures. Further study with a larger sample is required in order to investigate the course of the nerve, and its relationship to response to SNM.

Optimizing Neuromodulation Testing—Who, When, and How?

We review the current literature pertaining to recommendations for selecting appropriate patients and performing a test phase for sacral neuromodulation. Current literature reveals that this therapy can be successfully offered to patients with mild and severe forms of refractory overactive bladder, wet or dry. It can also be offered to elderly patients and patients with concurrent fecal incontinence, even in the setting of a known history of obstetric anal sphincter injury. Patients with non-obstructive urinary retention should be carefully selected with other etiologies ruled out, and an emphasis on those patients with suspected Fowler’s syndrome. We also summarize the recommendations for ideal lead placement and the advantages/disadvantages of a percutaneous nerve evaluation in the office compared to a staged procedure. The use of sacral neuromodulation for bladder dysfunction has evolved over the years. Patient selection and testing technique is an important component in optimizing the success of this therapy.

Sacral Neuromodulation in the Management of Bladder Pain Syndrome/Interstitial Cystitis

In this review, the current literature available about sacral neuromodulation (SNM) in the management of bladder pain syndrome/interstitial cystitis (BPS/IC) will be addressed. SNM has emerged in recent years as a minimally invasive option of management for refractory BPS/IC patients that otherwise should undergo reconstructive procedures. Although not approved by the FDA for this specific group of patients, the available data show a favourable response in both objective and subjective variables with a long-lasting effect. The implantation rate after the test phase is greater with the insertion of the quadripolar tined lead than with the monopolar percutaneous nerve evaluation. Most complications can be managed with reprogramming. The reintervention rate is still high, although it decreases when excluding surgeries for battery exchange. Sacral neuromodulation should be considered in the treatment algorithm of patients with BPS/IC, as suggested in international guidelines. It provides symptomatic relief in a significant proportion of patients, being a fully reversible procedure with a very favourable complications’ profile. Reintervention or explantation risk factors have not been consistently established.

MP30-03 A NOVEL SACRAL NEUROMODULATION INFECTION PROTOCOL IS ASSOCIATED WITH REDUCTION IN DEVICE INFECTION

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (MP30)1 Apr 2020MP30-03 A NOVEL SACRAL NEUROMODULATION INFECTION PROTOCOL IS ASSOCIATED WITH REDUCTION IN DEVICE INFECTION Hayden Hill*, Thomas Dukovac, Amy Long, James Conner, and Colin Goudelocke Hayden Hill*Hayden Hill* More articles by this author , Thomas DukovacThomas Dukovac More articles by this author , Amy LongAmy Long More articles by this author , James ConnerJames Conner More articles by this author , and Colin GoudelockeColin Goudelocke More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000869.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Sacral Neuromodulation (SNM) device infection is an expensive and distressing complication that may occur in up to 10% of implants. There are a multitude of possible risk factors for infection including antibiotic selection, skin preparation, as well as duration and modality of pre-implantation testing. We sought to develop an infection protocol in order to minimize the risk of device infection, decrease the use of toxic antibiotic agents, eliminate post-procedure antibiotic prophylaxis, and mitigate the additional risk of staged testing. Analysis of all prior infections in our database demonstrated infection with S. aureus and thus our protocol included screening and treatment of patients for S. aureus colonization of the nares. METHODS: Data were collected prospectively from January 2014 to September 2019 and pre-protocol comparison data from October 2011 to December 2013 were analyzed retrospectively as controls. All patients undergoing SNM procedures underwent nasal swab to screen for S. aureus. Patients with positive nasal cultures were treated with 7 days of intranasal mupirocin and MRSA-positive individuals underwent preoperative prophylaxis with Vancomycin. Patients with negative screening cultures were treated preoperatively with cefazolin unless allergic. Patients undergoing staged-lead testing were evaluated at one week for possible implantation. Any device explant associated with signs or symptoms of infection was recorded as a device infection. No post-procedure prophylaxis was used. RESULTS: A total of 108 SNM procedures in 80 pre-protocol patients and 634 procedures in 383 protocol patients were included. Infection rates were significantly reduced in the protocol group with respect to total procedures (4/108, 3.7% vs 3/634, 0.47%, p=0.0013) and total patients (4/80, 5.0% vs 3/383, 0.78%, p=.0049). Within the protocol group, 84.2% (322/382) of patients were negative for S. aureus, 11.2% (43/382) were MRSA positive, and 4.4% (17/382) were MSSA positive. Patients undergoing full implant after a staged test rather than after successful percutaneous nerve evaluation increased significantly in the protocol group (61.5%, 48/78 vs 99.1%, 241/243, p<.0001). Average duration of staged-lead testing decreased from a mean of 9.7 days (95% CI [8.6-10.8]) to 8.0 days (95% CI [7.6-8.4]). CONCLUSIONS: Instituting an SNM device infection protocol was associated with a significant reduction in rates of infection. Infection rates decreased despite increased rates of staged-lead testing and elimination of post procedure antibiotic prophylaxis. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e438-e439 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hayden Hill* More articles by this author Thomas Dukovac More articles by this author Amy Long More articles by this author James Conner More articles by this author Colin Goudelocke More articles by this author Expand All Advertisement PDF downloadLoading ...

Neuromodulation for Restoration of Urinary and Bowel Control.

Control of the lower urinary tract is a complex, multilevel process that involves the peripheral and central nervous systems. Patients with spinal cord diseases or injuries present with multiple bladder and bowel problems. The commonest are urinary, urgency, frequency, urge incontinence, retention and/or fecal incontinence. Though the first reports of neurostimulation to empty bladder came in 1970s', it was only in 1988 that Schmidt and Tanagho restarted discussion and application of neuromodulation and electrical stimulation of sacral nerve in urology. In April, 1999 - FDA approved the InterStim System for treatment of symptoms of urgency-frequency and urinary retention. In October 2000, Medtronic Commercial Release for SNS-Bowel was approved. In October 2002, the Tined lead was launched and N'Vision programmer was launched in the official market in Europe. SNM is now considered the third line of management in refractory cases of OAB, chronic NOUR, frequency and urgency. Role in neuropathic bladder is still being assessed. SNM includes a thorough preoperative assessment, PNE (Percutaneous Nerve Evaluation) without any muscle relaxation and finally installation of a permanent IPG after assessing reponse. We have an experience of over 20 patients in last 11 years. These include patients of refractory OAB, chronic NOUR and Cauda Equina Syndrome. We do a two-staged procedure in view of the high cost and abide by the AUA, EAU and ICS guidelines. Our long term results for neuropathic OAB are awaited.

Acute effect of sacral neuromodulation for treatment of detrusor overactivity on urodynamic parameters.

AimThe aim of this study is to evaluate the acute effects of sacral neuromodulation (SNM) on various urodynamic parameters.MethodsPatients with overactive bladder and detrusor overactivity (DO) who were planned for percutaneous nerve evaluation (PNE) were included. Directly after the PNE, a urodynamic study (UDS) was performed. The stimulation was turned off during the first UDS (UDS 1), and during the second filling cycle, stimulation was turned on (UDS 2). The UDS was followed by a test phase of 1 week and the bladder diaries were evaluated during an outpatient clinic visit. Primary outcome measures were the differences in UDS parameter values with SNM off and on.ResultsTen female patients were included in the study and completed the study protocol. Eight patients showed ≥50% improvement of symptoms following a test phase. There were no differences between UDS 1 and UDS 2 in the UDS parameters; bladder volume at first sensation, bladder volume at first DO, highest DO pressure, bladder capacity, maximum flow rate, and pressure at maximum flow rate.DiscussionNone of the aforementioned urodynamic parameters was influenced by acute SNM in patients who responded to SNM. To the best of our knowledge, this is the first study investigating the acute effects of SNM on bladder function.

How can we better manage drug-resistant OAB/DO? ICI-RS 2018.

Botulinum toxin A (BTX-A), sacral nerve stimulation (SNM), and posterior tibial nerve stimulation (PTNS) are established treatments for idiopathic overactive bladder (OAB) refractory to oral drug therapy. At the ICI-RS meeting in Bristol in 2018 athink tank was convened to address the question of how to better manage drug-resistant OAB/DO (detrusor overactivity). The think tank conducted a literature review and an expert consensus meeting focusing on the evidence for predicting response and adverse events (AEs) with the current therapies for drug-resistant idiopathic OAB. Several factors have been associated with poor outcomes using BTX-A including increasing age, body mass index, male sex, and frailty. Voiding dysfunction with BTX-A also appears to be more prevalent in those with increasing age, male sex, higher baseline postvoid residual and with poorer contractility as assessed by urodynamic parameters. SNM full implantation appears to be higher with the first stage tined lead placement procedure compared to percutaneous nerve evaluation. Urodynamics do not appear to predict outcomes with SNM. Patients with psychiatric comorbidity are more likely to experience AEs with SNM. Outcomes related to lead positioning and the number of active electrodes are mixed in predicting long term success. Patients with increased daytime frequency and lower first sensation of bladder filling were independent factors associated with success with PTNS. Further research is required to optimize these procedures and to better understand which patients will benefit from the various options available in managing refractory OAB.

Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury - a randomized controlled trial.

The purpose of this trial was to compare the effectiveness of sacral neuromodulation (SNM) with a submucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury (OASIS). This single-blinded randomized controlled trial at two hospital units in Norway included women with faecal incontinence following OASIS. Eligible women who had had a successful percutaneous nerve evaluation were randomly assigned to SNM or Permacol®. The primary outcome was the difference in the St Mark's incontinence score between baseline and 6months. Secondary outcomes were changes in the disease-specific quality of life (FIQL) and urinary incontinence (ICIQ-UI-SF) scores. Fifty-eight women were randomly assigned to SNM (n=30) and Permacol® (n=28). The reduction in the St Mark's score between baseline and 6months was 11.2 (SD 5.3) in the SNM group vs 2.3 (SD 5.0) in the Permacol® group, resulting in a difference of 8.9 (95% CI: 6.1-11.7, P<0.0001). The differences in the four scales of FIQL (lifestyle, coping, depression, embarrassment) were 0.90 (95% CI: 0.50-1.30, P<0.001), 1.05 (0.62-1.47, P<0.001), 0.52 (95% CI: 0.16-0.87, P=0.005) and 0.95 (95% CI: 0.50-1.40, P<0.001), respectively, in favour of SNM. The difference in the ICIQ-UI-SF was 5.0 (95% CI: 1.97-8.02, P=0.002) in favour of SNM. There were nine minor adverse events in the SNM group compared with seven in the Permacol® group (P=0.77). SNM was superior to Permacol® in terms of reduction of St Mark's score, ICIQ-UI-SF and the change of the FIQL in women with faecal incontinence following OASIS.