Sacral Neuromodulation Therapy Research Articles

Exploring the link between sacral neuromodulation and body balance mechanism

As the therapeutic mechanisms of Sacral Neuromodulation (SNM) continue to be investigated, recent long-term outcome study has revealed a intrigue association between SNM therapy and reported falls in patients. This observation has led to the formulation of a hypothesis suggesting that SNM may influence balance control during locomotion by altering sciatic nerve transmission, potentially contributing to an increased risk of falls. This concise article explores the hypothesis, emphasizing the need for further research to elucidate the potential connection between SNM and balance disorders. Understanding this link holds implications for patient safety and may further improve the optimization of SNM therapy.

Sacral neuromodulation therapy for urinary and defecatory disorders: experience in a Latin American public hospital.

To show the experience of a Latin American public hospital, with SNM in the management of either OAB, NOUR or FI, reporting feasibility, short to medium-term success rates, and complications. A retrospective cohort was conducted using data collected prospectively from patients with urogynecological conditions and referred from colorectal surgery and urology services between 2015 and 2022. Advanced or basic trial phases were performed on 35 patients, 33 (94%) of which were successful and opted to move on Implantable Pulse Generator (GG) implantation. The average follow-up time after definitive implantation was 82 months (SD 59). Of the 33 patients undergoing, 27 (81%)reported an improvement of 50% or more in their symptoms at last follow-up. Moreover, 30 patients (90%) with a definitive implant reported subjective improvement, with an average PGI-I "much better" and 9 of them reporting to be "excellent" on PGI-I. SNM is a feasible and effective treatment for pelvic floor dysfunction. Its implementation requires highly trained groups and innovative leadership. At a nation-wide level, greater diffusion of this therapy among professionals is needed to achieve timely referral of patients who require it.

The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study

Aim:I. To describe the number of false positive cases (FP), their characteristics and reason of occurrence in sacral neuromodulation therapy (SNM). Methods:A multidisciplinary prospective single-centre study was conducted between March 2018 and December 2021 with a follow-up of 12 months. Patients with therapy-resistant pelvic organ dysfunctions, scheduled for a 2-staged SNM procedure at the Urology (UD) and Colorectal Surgery Department (CRD), were included. All patients completed bowel and bladder diaries at baseline and during the test phase. Patient global impression of change (PGIC) and satisfaction scores concerning urological (US) and bowel symptoms (BS) were surveyed at baseline, at 1, 6 and 12 months after implantation. Patient characteristics and diary outcomes between FP and true positive cases (TP) were compared using non-parametric statistical tests. SPSS 27.0 was used. Clinical trial registration: NCT05313984. Results:The FP ratio at one month follow-up was 16% (11/68), with a FP ratio of 13% (N=6/48) and 25% (N=5/20) for the urology patients and colorectal surgery patients, respectively. There were no significant differences in demographic characteristics between the FP and TP group (p > 0,05), however there is a trend towards FP having worse baseline symptoms than TP. The FP group had a significant lower baseline and test phase 24 h diuresis (p < 0,05), without having a significant different intake than the TP group. Conclusion:At one month after full implantation of a sacral neuromodulator, 16% of the patients showed loss of subjective success. These FP could not be predicted from demographic characteristics, most likely due to the small study population. Although not significant, FP seem to have worse symptoms at baseline than TP, with a significant lower diuresis regardless of fluid intake.

Sacral Neuromodulation Therapy for Urinary and Fecal Incontinence in Patients With Multiple Sclerosis: Report of 6 Cases and Literature Review.

Urinary incontinence (UI) and fecal incontinence (FI) are challenging manifestations of multiple sclerosis (MS) that have historically been treated with limited success. Sacral neuromodulation (SNM) has provided successful resolution of UI and FI in the general population and in patients with neurologic conditions, including MS. We report on 6 patients with MS-related incontinence treated successfully with SNM and review the literature. Medical records were reviewed retrospectively to identify patients with MS seeking treatment for incontinence. Six patients were identified, and each is presented with follow-up assessment of the severity of UI or FI. All 6 individuals with MS had severe incontinence that had been refractory to therapies that included medications and pelvic floor physical therapy. Five patients reported severe UI and 2 patients reported severe FI. Each patient was successfully treated with SNM, with large reductions of incontinence scores and improved quality of life. In this case series, SNM was effective as a treatment for UI and FI among patients with MS. These findings confirm other published series that have reported the success of SNM in patients with MS with incontinence. Sacral neuromodulation should be considered as a potential treatment option for patients with MS and UI and/or FI.

Investigating a Closed Loop Neural Control System to Optimize Sacral Neuromodulation

Background and Hypothesis:Approximately 16% of the American population suffers from overactive bladder, with 25-40% of patients reporting unsatisfactory results following first line treatments. Sacral neuromodulation is a well-established, minimally invasive treatment option for several forms of bladder and bowel dysfunction that are non-responsive to first line pharmacologic or behavioral therapies. While more broadly applicable stimulus parameters are being investigated, the precise set of nerve fibers whose activity regulates optimal bladder function(s) is not known, leading to high levels of treatment variability between patients and within patients over time. We hypothesize that treatment efficacy and durability could be rapidly improved by continuously tuning the electrical stimulus waveform and pattern of stimulation to recruit the nerve fiber populations that mediate micturition.&#x0D; Experimental Approach:We aim to access the sacral (S2-4) nerves and implant a set of recording and stimulating bipolar cuff electrodes (FNC-400-V-R-C-2C-30, Micro-Leads, Somerville, MA, USA) to measure the evoked CAP of the sacral nerves at various combinations of pulse amplitude and duration. Simultaneously, we will measure changes in bladder pressure using a pressure transducer attached to a bladder catheter and amplifier. By measuring how the bladder responds to all applied nerve stimulation parameters we will be able use an Autonomous Neural Control algorithm to identify the compound nerve action potential response that produces the most robust changes in pressure.&#x0D; Results:We developed a surgical protocol, currently pending PACUC approval, that allows us to decode and encode specific CAP signatures that represent the firing activity of distinct subsets of nerve fibers, each differing in diameter, degree of myelination, activation threshold, conduction speed, and presumably function.&#x0D; Conclusion and Potential Impact:This study aims to act as proof of concept for a system that selects stimulation parameters based on fibers required to produce a desired response rather than patient tolerance to stimulation parameters, ultimately improving efficacy of sacral neuromodulation therapy.

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder.

To evaluate the impact of cognitive impairment (CI) diagnoses on sacral neuromodulation (SNM) outcomes in older patients. We completed a retrospective review of all patients aged ≥55 years who underwent test-phase SNM (peripheral nerve evaluation (PNE) or stage 1) for overactive bladder (OAB) between 2014 and 2021 within a large multi-regional health system. Patient demographics, relevant comorbidities, CI diagnoses (dementia or mild CI), and SNM procedures were recorded. Logistic regression modeling was performed to evaluate the impact of CI on SNM implantation rates. Five-hundred and ten patients underwent SNMtest phase (161 PNE, 349 Stage 1) during the study period. The mean age was 71.0(8.5) years, and most (80.6%) were female. Overall, 52(10.1%) patients had a CI diagnosis at the time of SNM, and 30 (5.8%) were diagnosed at a median of 18.5 [9.25, 39.5] months after SNM. Patients with CI diagnoses were older, with more comorbidities, and were more likely to undergo PNE. Univariable comparison found no difference in implantation rate based on pre-SNM CI (85.4% vs. 76.9%, p = 0.16). Multivariable analysis identified PNE (OR 0.43, 95%CI 0.26-0.71), age (OR 0.96, 95%CI 0.93-0.98), and prior beta-3 agonist use (OR 0.60, 95%CI 0.37-0.99) but not CI or dementia as independent negative predictors of implantation. Implanted patients had a median follow-up of 25 [12.0, 55.0] months. Explant and revision rates did not differ according to CI. Patients with OAB and CI diagnoses proceed to SNM implant at rates similar to patients without CI diagnoses. A diagnosis of CI should not necessarily exclude patients from SNM therapy for refractory OAB.

Effectiveness and safety of sacral neuromodulation for neurogenic bladder

ABSTRACT Background The treatment of neurogenic bladder (NB) is a challenge because conventional therapy often fails. Sacral neuromodulation (SNM) is a minimally invasive technique and an unconventional treatment for neurogenic bladder. Its research is still in the exploratory stage. The research on its effectiveness and safety is not clear. Objective To assess the effectiveness and safety of sacral neuromodulation (SNM) for neurogenic bladder (NB). Methods By searching the PubMed databases and Cochrane Library databases, combined with the method of literature tracing, the clinical researches and works on neurogenic bladder and sacral neuromodulation therapy were collected. Two reviewers independently selected and extracted data, (1) determine whether the study meets the inclusion criteria and exclude the literature that meets the exclusion criteria. (2) Researchers’ screening results and data, if there are differences in the results, will be discussed to eliminate the differences. (3) Read the full text of the literature carefully to determine the final literature to be included. (4) The relevant data of 11 independent studies, a total of 291 patients, were systematically reviewed using review manager 5.3 software. Results This research included 11 independent studies with a total of 291 patients. The improvements of main outcomes before and after SNM therapy were significant: incontinence episodes /24 h (WMD −2.52; 95%CI-3.14-1.90; p <0.001), frequency/24 h (WMD-5.96; 95%CI −6.27，-5.66; p <0.001), voiding volume (WMD 116.09 mL; 95%CI 86.68，145.51; p <0.001), cystometric capacity (WMD 129.84 mL; 95%CI 100.53, 159.15; p <0.001), post-void residual volume (WMD-198.00 mL; 95%CI-264.60, −131.40; p <0.001), clean intermittent self-catheterization/24 h (WMD-2.48; 95%CI −2.96, −2.00; p <0.001). Conclusion This systematic review indicated that the sacral neuromodulation treatment for neurogenic bladder was effective and safe.

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.

Sacral neuromodulation for neurological disease-induced lower urinary tract symptoms in Saudi Arabia: a single-centre experience.

ObjectiveTo evaluate the effectiveness of sacral neuromodulation therapy (SNM) for lower urinary tract symptoms (LUTS) caused by neurological diseases.MethodsThis prospective cohort study enrolled patients that developed LUTS secondary to neurological disorders. All patients underwent staged SNM. A 5-day voiding diary was used to evaluate their response to the stage 1 procedure. Implantation of the full system during the stage 2 procedure was undertaken in patients that had ≥50% improvement on their voiding diary.ResultsTwenty-one patients were included in the study with the following neurological aetiologies: diabetes mellitus (n = 2), myelitis (n = 3), multiple sclerosis (n = 5), spinal cord injury (n = 10) and cerebrovascular accident (n = 1). Fifteen patients underwent the stage 1 procedure successfully; their mean age was 47.5 years and the mean follow-up was 29 months. SNM resulted in significantly increased voided volume/void/day, decreased leaking episodes/day, decreased postvoiding residual/day and decreased number of clean intermittent catheterization/day compared with baseline. Five patients were highly satisfied, nine were moderately satisfied and one patient was not satisfied with the therapy.ConclusionSNM was an effective therapy for LUTS caused by neurological disease and there was a high rate of patient satisfaction.

Longitudinal urinary microbiome characteristics in women with urgency urinary incontinence undergoing sacral neuromodulation.

The objective was to evaluate the stability of the urinary microbiome communities in women undergoing sacral neuromodulation (SNM) for urgency urinary incontinence (UUI). We hypothesized that clinical response to SNM therapy would be associated with changes in the urinary microbiome. Women completed the Overactive Bladder Questionnaire Short-Form, the International Consultation on Incontinence Questionnaire Short Form, and the Female Sexual Function Index at baseline and 3 months post-SNM implantation. Transurethral urinary specimens were obtained for microbiome analysis at baseline and 3 months postoperatively. The V4 region of the 16S rRNA gene (515F-806R) was amplified with region-specific primers, and Amplicon Sequence Variants (ASVs) were identified with a closed-reference approach of taxonomic classification. Alpha-diversity was calculated using the phylogenetic (i.e., Faith's phylogenetic diversity) and nonphylogenetic metrics (i.e., Shannon diversity, and Pielou's evenness) using the QIIME2 plugin. Longitudinal paired volatility analysis was performed using the DEICODE and Gemelli plugin to account for host specificity across both time and space. Nineteen women who underwent SNM and provided both baseline and 3-month urine samples were included in this analysis. Women reported improvement in objective (number of UUI episodes) and subjective (symptom severity and health-related quality of life) measures. Ninety percent of the bacteria were classified as Bacteroidetes, Firmicutes, Proteobacteria, and Actinobacteria. No significant differences were observed in each subject's beta-diversity at 3 months compared with their baseline microbiome. Our descriptive pilot study of a cohort of women who had achieved objective and subjective improvements in UUI following SNM therapy demonstrates that the urinary microbiome remains relatively stable, despite variability amongst the cohort.

Closed-loop sacral neuromodulation for bladder function using dorsal root ganglia sensory feedback in an anesthetized feline model.

Overactive bladder patients suffer from a frequent, uncontrollable urge to urinate, which can lead to a poor quality of life. We aim to improve open-loop sacral neuromodulation therapy by developing a conditional stimulation paradigm using neural recordings from dorsal root ganglia (DRG) as sensory feedback. Experiments were performed in 5 anesthetized felines. We implemented a Kalman filter-based algorithm to estimate the bladder pressure in real-time using sacral-level DRG neural recordings and initiated sacral root electrical stimulation when the algorithm detected an increase in bladder pressure. Closed-loop neuromodulation was performed during continuous cystometry and compared to bladder fills with continuous and no stimulation. Overall, closed-loop stimulation increased bladder capacity by 13.8% over no stimulation (p < 0.001) and reduced stimulation time versus continuous stimulation by 57.7%. High-confidence bladder single units had a reduced sensitivity during stimulation, with lower linear trendline fits and higher pressure thresholds for firing observed during stimulation trials. This study demonstrates the utility of decoding bladder pressure from neural activity for closed-loop control of sacral neuromodulation. An underlying mechanism for sacral neuromodulation may be a reduction in bladder sensory neuron activity during stimulation. Real-time validation during behavioral studies is necessary prior to clinical translation of closed-loop sacral neuromodulation.

Removal of sacral neuromodulation quadripolar tined-lead using a straight stylet: description of a surgical technique

BackgroundUp to 7.5% of tined-lead removals in patients having sacral neuromodulation (SNM) therapy are associated with a lead breakage. It is still unclear what adverse effects can be caused by unretrieved fragments. The aim of our study was to describe the lead removal technique we have been using for the last 2 years in our centre.MethodsWe retrospectively enrolled patients who had lead removal between January 2018 and January 2020 using our standardized technique. The novelty of the technique is in the use of the straight stylet, which is available in the quadripolar tined-lead kit. The stylet gives the electrode greater stiffness, reducing interactions with surrounding tissues and probability of damage or breakage during removal.ResultsIn 59 patients (42 women, mean age 57.2 years [range 40–79 years]) the lead was removed using our standardized technique. In 44 of 59 patients, the tined-lead was removed within 2 months from the SNM-test, due to lack of beneficial effects. In 15 patients the electrode was removed because of failure of definitive implantation. Meantime from definitive implantable pulse generator (IPG) implantation to lead removal was 67.9 months. We recorded only 1 case of lead-breakage during removal: a female patient with a non-tined lead fixed on sacral bone, placed 18 years previously using an open technique.ConclusionsLead breakage during removal is not uncommon and adverse effects of retained fragments may occur. Our technique has been safely used for the last 2 years in our centre, with no episodes of lead breakage or retained fragments, except for one non-tined electrode.

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study.

The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStimTM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable. This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events. A total of 221 subjects with a mean age of 62.1years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p<0.0001). Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.

A prospective, multicenter, international study to explore the effect of three different amplitude settings in female subjects with urinary urge incontinence receiving interstim therapy.

AimsThe aim of this study is to evaluate the effect of sub‐sensory amplitude settings of sacral neuromodulation therapy on overactive bladder symptoms in subjects with urinary urge incontinence.MethodsSubjects who qualified for a neurostimulator device implant were randomized to one of three amplitude settings (50% of sensory threshold [ST], 80% of ST, and ST). Subjects completed urinary voiding diaries (3‐day), International consultation on incontinence modular questionnaire—overactive bladder symptoms quality of life questionnaire, and patient global impression of improvement (PGI‐I) to assess change in voiding symptoms and quality of life (QoL) from baseline through 12 weeks.ResultsForty‐eight subjects had a successful test stimulation, 46 were implanted with a neurostimulator device and 43 completed the 12‐week follow‐up visit. The change from baseline to 12 weeks is −3.0 urinary incontinence (UI) episodes/day (95% confidence interval [CI]: −4.4 to −1.7) for the 50% of sensory threshold group, −2.9 UI episodes/day (95% CI: −4.7 to −1.2) for 80% of sensory threshold group, and −3.6 UI episodes/day (95% CI: −5.2 to −1.9) for the sensory threshold group. In each randomized group, improvements were observed in health‐related QoL, its subscales, and symptom interference. Subjects across all three randomization groups reported on the PGI‐I that their bladder condition was better at 12 weeks compared to before they were treated with InterStim therapy.ConclusionThese findings provide insights into possible advancements in the postimplantation phase of therapy with potential for improved patient comfort and increased device longevity.

Sacral neuromodulation implanted patients: Patient concerns during the COVID-19 pandemic and practical modifications.

Objective:To study the effect of the COVID-19 pandemic on sacral neuromodulation (SNM) implanted patients and examine patient concerns.Methodology:A web-based survey was sent to all SNM patients, including those with implants and who had a cancelled operation because of the pandemic. The survey consisted of 15 questions in Arabic language, which sought to evaluate outcomes, as well as patient concerns and preferences during the COVID-19 pandemic.Results:A total of 66 patients were contacted, and of which, 62 replied. Most of the patients (n = 51; 82.3%) had the device implanted, and 11 (17.7%) patients had a postponed operation secondary to the pandemic. There were 20 males and 42 females. The mean age was 34 years ± SD 16.5 (9–62 years). Indications for sacral neuromodulation therapy were refractory overactive bladder OAB 35 (56.5%), retention 17 (27.4%), OAB + retention 3 (4.8%). When questioning the effect of the lockdown on patients, most reported no effect (43.5%), while 14.5% had some programming difficulties. The patients preferred telephone calls for device emergencies and clinic follow-up with 88.7% and 98.4%, respectively. Most patients had no concerns regarding their Interstim device during the pandemic and found it manageable; 8.1% had insurance concerns due to the economic changes.Conclusion:Patients with implanted SNM for lower urinary tract symptoms were mainly concerned with device programming. Telemedicine is a great solution for continuous care in this group.

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

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. 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. 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 toextended 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). 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.

Sacral neuromodulation system for treating refractory overactive bladder.

Sacral neuromodulation (SNM) is a therapy system used to improve bladder function, including in people with overactive bladder (OAB). It is safe and can improve quality of life. SNM helps improve symptoms through direct modulation of nerve activity; it involves electrically stimulating the sacral nerves that carry signals between the pelvic floor, spinal cord and the brain and is thought to normalise neural communication between the bladder and brain. If patients with OAB do not respond to non-surgical and conservative options, minimally invasive procedures can be offered, including SNM. SNM is performed in two stages: the trial phase, to assess whether it would be effective in the long term; and permanent implantation. This year, the National Institute for Health and Care Excellence (NICE) released guidance on the Axonics SNM System® for treating refractory OAB. The Axonics System is rechargeable and lasts at least 15 years, minimising the need for repeat surgery. NICE suggests the Axonics System may have cost advantages for the NHS. Having more than one SNM therapy option available increases options for patients, offering them a choice of handsets and rechargeable versus non-rechargeable implants. Three case studies illustrate how the system works in practice.

Optimizing sacral neuromodulation for low anterior resection syndrome: learning from our experience.

The aim of this work was to review our institutional series of patients treated with sacral neuromodulation (SNM) for low anterior resection syndrome (LARS) and evaluate possible factors associated with therapeutic success. Twenty-five patients were treated with SNM for LARS between 2008 and 2019. SNM was performed as per our institutional protocol. Patients were evaluated with Wexner and LARS scores before and after SNM treatment. A visual analogue scale (1-10) was used to evaluate overall patient satisfaction with SNM. There were significant differences between the mean LARS score values before (37.82) and after (29) SNM therapy (P<0.004). The mean Wexner score was higher (16.24) before SNM treatment than afterwards (11.13) (P<0.004). There was a direct relationship between the height of anastomosis and LARS score (P=0.035): there were big changes in LARS scoring (pre-/post-SNM therapy) in patients with higher anastomoses, and vice versa. Patients who received radiotherapy scored lower in mean satisfaction (6.38) than patients without previous radiotherapy (8.22) (P=0.008). There was an important positive association between Wexner score and patient satisfaction (P=0.001): relevant changes in Wexner scoring after SNM therapy were associated with high patient satisfaction, and vice versa. Our study showed a relationship between changes in Wexner and LARS scores before and after SNM and overall patient satisfaction with SNM therapy. These findings also suggest patients with previous radiotherapy may have worse results with SNM (based on lower overall satisfaction), and that higher anastomoses have a greater impact on the post-SNM LARS score.

Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study

BackgroundReal-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. ObjectiveTo evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant. Design, setting, and participantsThis is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0±3.8 mo. Outcome measurements and statistical analysisEffectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test. Results and limitationsVoids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p<0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p<0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p<0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p<0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo. ConclusionsThrough a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients. Patient summaryThese analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother. Trial registrationClinicalTrials.gov: NCT02186041

Primary care providers’ knowledge about the therapeutic management of refractory pelvic floor dysfunctions in Flanders, Belgium: a cross-sectional study

Background Pelvic floor dysfunctions (PFD) are prevalent conditions in primary care practice. Basic knowledge of second-line therapies among primary care providers (PCPs) is indispensable to well-inform refractory patients and improve their access to specialized care. Objectives Getting insight into the extent of knowledge about second-line therapies for refractory PFD among PCPs in Flanders, Belgium. Methods From January to March 2019 Flemish PCPs participated in the OptiLUTS trial – Part A (EC/2018/0244), by the completion of a 22-item online Dutch questionnaire. Prevalence of PCPs having awareness about sacral neuromodulation (SNM), intradetrusor botulinum toxin injections (BTX) and percutaneous tibial nerve stimulation (PTNS) was explored. Descriptive statistics, univariate analyses, and multiple logistic regression analyses were performed. Results Sixty PCPs, 55% GPs, 45% GP trainees, median age 29 years, participated. Respectively, 90, 73 and 5% had ever heard about BTX, SNM and PTNS. The profession was an independent predictive factor for never having heard of SNM therapy, GPs being more likely to have a lack of knowledge than trainees (OR = 29, 95%CI [1.9–442.5]). Ninety-three percent want to learn more about these therapies. Conclusion There is a margin for improvement in the knowledge of PCPs regarding therapies for refractory PFD. Awareness among PCPs should be increased for the optimization of patient care.