Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice.

OBJECTIVES: In some patients treated for urinary or fecal incontinence with sacral neuromodulation (SNM) persistence of symptoms, a reduction in efficacy or adverse effects of stimulation can occur. In such situations, further programming of the SNM device can help resolve problems. Infrequently hardware failure is detected. This article aims to provide practical guidance to solve sub-optimal outcomes (troubleshooting) occurring in the course of SNM therapy. MATERIALS AND METHODS: A systematic literature review was performed. Collective clinical experience from an expert multidisciplinary group was used to form opinion where evidence was lacking. RESULTS: Circumstances in which reprogramming is required are described. Actions to undertake include changes of electrode configuration, stimulation amplitude, pulse frequency, and pulse width. Guidance in case of loss of efficacy and adverse effects of stimulation, developed by a group of European experts, is presented. In addition, various hardware failure scenarios and their management are described. CONCLUSIONS: Reprogramming aims to further improve patient symptoms or ensure a comfortable delivery of the therapy. Initial changes of electrode configuration and adjustment of stimulation parameters can be performed at home to avoid unnecessary hospital visits. A logical and stepwise approach to reprogramming can improve the outcome of therapy and restore patient satisfaction.

Programming Algorithms for Sacral Neuromodulation: Clinical Practice and Evidence-Recommendations for Day-to-Day Practice.

BACKGROUND: In sacral neuromodulation (SNM), stimulation programming plays a key role to achieve success of the therapy. However to date, little attention has been given to the best ways to set and optimize SNM programming during the test and chronic stimulation phases of the procedure. OBJECTIVE: Standardize and make SNM programming easier and more efficient for the several conditions for which SNM is proposed. METHODS: Systematic literature review and collective clinical experience report. RESULTS: The basic principles of SNM programming are described. It covers choice of electrode configuration, stimulation amplitude, pulse frequency and pulse widths, while use of cycling is also briefly discussed. Step-by-step practical flow charts developed by a group of 13 European experts are presented. CONCLUSIONS: Programming of SNM therapy is not complex. There are few programming settings that seem beneficial or significantly impact patient outcomes. Only four basic electrode configurations could be identified according to four different options to define the cathode. In a majority of patients, the proposed stimulation parameters will allow a satisfactory improvement for long periods of time. A regular follow-up is, however, necessary to assess and eventually optimize results, as well as to reassure patients.

New Technologies and Applications in Sacral Neuromodulation: An Update.

Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.

A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy.

PURPOSE: Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. METHODS: In the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. RESULTS: Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. CONCLUSION: Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. TRIAL REGISTRATION: clinicaltrials.gov -Identifier NCT01240772.

International Continence Society best practice statement for use of sacral neuromodulation.

AIMS: Sacral neuromodulation (SNM) is an accepted therapy for a variety of conditions. However, despite over 20 years of experience, it remains a specialized procedure with a number of subtleties. Here we present the recommendations issued from the International Continence Society (ICS) SNM Consensus Panel. METHODS: Under the auspices of the ICS, eight urologists, three colorectal surgeons and two urogynecologists, covering a wide breadth of geographic and specialty interest representation, met in January 2017 to discuss best practices for neuromodulation. Suggestions for statements were submitted in advance and specific topics were assigned to committee members, who prepared and presented supporting data to the group, at which time each topic was discussed in depth. Best practice statements were formulated based on available data. This document was then circulated to multiple external reviewers after which final edits were made and approved by the group. RESULTS: The present recommendations, based on the most relevant data available in the literature, as well as expert opinion, address a variety of specific and at times problematic issues associated with SNM. These include the use of SNM for a variety of underlying conditions, need for pre-procedural testing, use of staged versus single-stage procedures, screening for success during the trial phase, ideal anesthesia, device implantation, post-procedural management, trouble-shooting loss of device function, and future directions for research. CONCLUSIONS: These guidelines undoubtedly constitute a reference document, which will help urologists, gynecologists, and colorectal surgeons optimize their use of SNM for refractory urinary urgency and frequency, UUI, NOR, and FI.

Sacral Neuromodulation: Standardized Electrode Placement Technique.

INTRODUCTION: Sacral neuromodulation (SNM) (sacral nerve stimulation SNS) has become an established therapy for functional disorders of the pelvic organs. Despite its overall success, the therapy fails in a proportion of patients. This may be partially due to inadequate electrode placement with suboptimal coupling of the electrode and nerve. Based on these assumptions the technique of sacral spinal neuromodulation has been redefined. All descriptions relate to the only currently available system licensed for all pelvic indications (Medtronic Interstim® ). METHOD: An international multidisciplinary working party of ten individuals highly experienced in performing SNM convened two meetings (including live operating) to standardize the implant procedure. This report addresses the main steps to optimal electrode lead placement in temporal sequence. RESULTS: Key elements of the electrode placement are radiological marking, the use of a curved stylet, the entry of the electrode into the sacral foramen and its progression through the foramen, its placement guided by a combination of a typical appearance in fluoroscopy and achieving specific motor/sensory responses with stimulation. The report describes quadripolar electrode placement and then either insertion of a connecting percutaneous extension lead or permanent implantation of the programmable device. CONCLUSION: Standardization of electrode placement may ensure close electrode proximity to the target nerve providing a higher likelihood for optimal effect with less energy consumption (better battery longevity), more programming options with more electrode contacts close to the nerve and reduced likelihood of side-effects. The potentially better clinical outcome needs to be demonstrated.

Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.

OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND: DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS: Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS: DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.

Safety of laparoscopic ventral rectopexy in the elderly: results from a nationwide database.

BACKGROUND: Laparoscopic ventral rectopexy is an established procedure in the treatment of posterior pelvic organ prolapse. It is still unclear whether this procedure can be performed safely in the elderly. OBJECTIVE: This study aimed to assess the effects of age on the outcome of laparoscopic ventral rectopexy performed for patients with pelvic organ prolapse. DESIGN: This study was a retrospective cohort analysis with data from a national registry. SETTINGS: The study was conducted in a tertiary care setting. PATIENTS: Patients undergoing laparoscopic ventral rectopexy were identified from discharge summaries. Patients were stratified according to age, including patients <70 (group A) and ≥ 70 (group B) years old. MAIN OUTCOME MEASURES: Variables analyzed included sex, age, diagnosis, associated pelvic organ prolapse, comorbidities, length of stay, complications (Clavien-Dindo scale), and mortality. RESULTS: Among 4303 patients (98.2% women) who underwent a laparoscopic ventral rectopexy, 1263 (29.4%) were >70 years old (mean age, 76.2 ± 5.0 years). Main diagnoses were vaginal vault prolapse (53.0% [group A] vs 47.0% [group B]; p value not significant) and rectal prolapse (17.7 vs 26.8%; p value not significant). Comorbidity was significantly increased in group B (mean length of stay, 5.6 ± 3.6 vs 4.7 ± 1.8 days; p < 0.001) and minor complications (8.4% vs 5.0%; p < 0.001) were significantly increased in group B, whereas major complications were not different (group A, 0.7%; group B, 0.9%; p = 0.40) after univariate analysis. Multivariate analysis found no significant differences between groups. The subgroup analysis of patients >80 years old (n = 299) showed no differences. Each group had 1 postoperative mortality. LIMITATIONS: Limitations of the study include its retrospective design, lack of prestudy power calculation, possible inaccuracy of an administrative database, and selection bias. CONCLUSIONS: Laparoscopic ventral rectopexy appears to be safe in select elderly patients.

Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial.

PURPOSE: This study was designed to assess the safety and outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients. METHODS: A total of 119 women patients who suffered from obstructed defecation with associated rectocele and rectal intussusception were randomized to stapled transanal rectal resection or biofeedback training. Stapled transanal rectal resection was performed by using two circular staplers to produce transanal full-thickness rectal resection. Primary outcome was symptoms of obstructed defecation resolution at 12 months; secondary outcomes included safety, change in quality of life score, and anatomic correction of rectocele and rectal intussusception. RESULTS: Fourteen percent (8/59) stapled transanal rectal resection and 50 percent (30/60) biofeedback training patients withdrew early. Eight (15 percent) patients treated with stapled transanal rectal resection and 1 (2 percent) biofeedback patient experienced adverse events. One serious adverse event (bleeding) occurred after stapled transanal rectal resection. Scores of obstructed defecation improved significantly in both groups as did quality of life (both P < 0.0001). Successful treatment was observed in 44 (81.5 percent) stapled transanal rectal resection vs. 13 (33.3 percent) evaluable biofeedback training patients (P < 0.0001). Functional benefit was observed early and remained stable during the study. CONCLUSIONS: In this controlled trial, stapled transanal rectal resection was well tolerated, was more effective than biofeedback training for the resolution of obstructed defecation symptoms, and improved quality of life, with minimal risk of impaired continence. Thus, stapled transanal rectal resection offers a new treatment alternative for obstructed defecation after failure of conservative measures including biofeedback training, a noninvasive approach.