Outcomes and efficacy of magnetic resonance imaging-compatible sacral nerve stimulator for management of fecal incontinence: A multi-institutional study.

BACKGROUND: Fecal incontinence (FI) is an involuntary passage of fecal matter which can have a significant impact on a patient's quality of life. Many modalities of treatment exist for FI. Sacral nerve stimulation is a well-established treatment for FI. Given the increased need of magnetic resonance imaging (MRI) for diagnostics, the InterStim which was previously used in sacral nerve stimulation was limited by MRI incompatibility. Medtronic MRI-compatible InterStim was approved by the United States Food and Drug Administration in August 2020 and has been widely used. AIM: To evaluate the efficacy, outcomes and complications of the MRI-compatible InterStim. METHODS: Data of patients who underwent MRI-compatible Medtronic InterStim placement at UPMC Williamsport, University of Minnesota, Advocate Lutheran General Hospital, and University of Wisconsin-Madison was pooled and analyzed. Patient demographics, clinical features, surgical techniques, complications, and outcomes were analyzed. Strengthening the Reporting of Observational studies in Epidemiology(STROBE) cross-sectional reporting guidelines were used. RESULTS: Seventy-three patients had the InterStim implanted. The mean age was 63.29 ± 12.2 years. Fifty-seven (78.1%) patients were females and forty-two (57.5%) patients had diabetes. In addition to incontinence, overlapping symptoms included diarrhea (23.3%), fecal urgency (58.9%), and urinary incontinence (28.8%). Fifteen (20.5%) patients underwent Peripheral Nerve Evaluation before proceeding to definite implant placement. Thirty-two (43.8%) patients underwent rechargeable InterStim placement. Three (4.1%) patients needed removal of the implant. Migration of the external lead connection was observed in 7 (9.6%) patients after the stage I procedure. The explanation for one patient was due to infection. Seven (9.6%) patients had other complications like nerve pain, hematoma, infection, lead fracture, and bleeding. The mean follow-up was 6.62 ± 3.5 mo. Sixty-eight (93.2%) patients reported significant improvement of symptoms on follow-up evaluation. CONCLUSION: This study shows promising results with significant symptom improvement, good efficacy and good patient outcomes with low complication rates while using MRI compatible InterStim for FI. Further long-term follow-up and future studies with a larger patient population is recommended.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Technical and functional outcome after sacral neuromodulation using the "H" technique.

BACKGROUND: Sacral neuromodulation (SNM) is a widely accepted treatment for pelvic floor disorders, including constipation and fecal incontinence (FI). In 2017, a standardized electrode placement method, the H technique, was introduced to minimize failure rates and improve clinical outcomes. We aimed to investigate the technical feasibility and functional outcome of the procedure. METHODS: In this prospective study, we evaluated the first 50 patients who underwent SNM according to the H technique between 2017 and 2020 at a tertiary care hospital. Patient demographic and clinical data were collected, and the impact of various factors on patients' postoperative quality of life (QoL) was assessed after a follow-up of 40 months. Functional outcome was monitored prospectively using a standardized questionnaire. RESULTS: Of 50 patients, 36 (72%) reported greater than 50% symptom relief and received a permanent implant (95% CI: 58.3-82.5). We observed 75% success in relieving FI (95% CI: 58.9-86.3) and 64% in constipation (95% CI: 38.8-83.7). Complication occurred in five (10%) patients. Preoperative vs. postoperative physical and psychological QoL, Vaizey score, and obstructed defecation syndrome (ODS) scores revealed significant improvements (all p < 0.01). Male gender was significantly associated with postoperative complications (p = 0.035). CONCLUSION: We provide evidence for the technical feasibility and efficacy of the SNM implantation using the H technique. The medium-term results are promising for patients with FI and constipation. Male patients and those with a BMI > 25 are more prone to perioperative complications.

Chronic Penile Pain: A Poorly Researched and Managed Life-Debilitating Condition.

Chronic penile pain is a complex clinical entity with limited diagnostic criteria and treatment options. Due to limited reporting of these cases, there are no clear clinical treatments and indications for when these patients present to the clinic. This case report will highlight the diagnostic challenges encountered and the subsequent management strategies employed while working up a patient with penile pain. We present a 37-year-old male with a six-year history of debilitating penile pain, urinary frequency, and urgency that is exacerbated by sexual arousal and touch. Initial evaluations attributed the symptoms to medication side effects, leading to medication changes. Despite multiple treatments, including gabapentin, solifenacin, vibegron, and a variety of specialist consultations, the patient's condition persisted. Neurological evaluation revealed pudendal neuropathy. Medical management with pudendal nerve blocks and gabapentin did not provide lasting relief, so surgical interventions were considered. Subsequent treatment with an InterStim II device (Medtronic Inc., Minneapolis, MN) initially resulted in significant symptom improvement. Unfortunately, at the seven-month follow-up, his pain returned. Further evaluation and additional treatment options are currently under consideration. This case report highlights the diagnostic complexity and limited treatment options for chronic penile pain. It suggests that sacral neuromodulation, although lacking long-term data, may offer temporary relief in cases refractory to medical therapy. Further research is needed to enhance our understanding and management of this challenging condition.

Neuromodulation.

Sacral neuromodulation (SNM) has been available in the United States for more than 20 years and is a guideline-recommended therapy by both the American Urological Association and the American Society of Colon and Rectal Surgeons, with proven long-term success for urinary urgency incontinence, urinary urgency frequency, nonobstructive urinary retention, and fecal incontinence. Initially the therapy involved a more invasive surgical approach that included a large cut down over the sacrum. This article reviews recent advancements in SNM therapy including updates in best practices for implant technique, technological innovations, and the new clinical literature relevant to contemporary practice.

Non-invasive massage technique to aid in removal of a tined sacral neuromodulation lead.

INTRODUCTION AND HYPOTHESIS: Describe a novel technique for retrieval of the Interstim lead in part based on techniques used in massage therapy. METHODS: Retrospective review of patients (single surgeon) identified by CPT code 64585 over 10 years. Exclusion criteria included patients who (1) had explantation for active infection or (2) did not proceed with a stage 2 implant (in the event of a staged procedure). To effect removal, the surgeon applies a focused massage with firm deliberate pressure in deep circular motions to the insertion site and surrounding tissue. At the same time, gentle steady traction is applied to the lead (from the IPG pocket) by the surgeon. RESULTS: Sixty women were identified. Mean implant duration was 24 (6-60) months. There were three lead fractures at retrieval (5%). In all three occurrences, the inner conductor wire was removed despite leaving the tined fragment in place. The author did not perform a cutdown to retrieve the retained fragment. There were no peri- or postoperative complications. CONCLUSIONS: Lead removal is safely accomplished in a matter of a few minutes with the presented technique without the need for a cutdown. Lead breakage was 5% and similar to more invasive techniques.

Anesthetic Considerations and Perioperative Management of Sacral Neuromodulators: Literature Review and Initial Recommendations.

OBJECTIVE: Sacral neuromodulation (SNM) is gaining increased integration in the realm of medicine. With increasing use, anesthetic and periprocedural considerations must be understood. The goal of this article is to review and consolidate available literature on device management in these settings. MATERIALS AND METHODS: Searches were preformed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Electronic searches were systematically conducted in the PubMed and Embase databases. RESULTS: Literature is reported on device management in the following settings: general operating room recommendations, electrocautery, ultrasound and other forms of diathermy, implanted cardiac devices, defibrillation, and magnetic resonance imaging. DISCUSSION: SNM devices have shown efficacy in treatment for a wide array of conditions. When proper precautions and guidelines are followed, the device can be safely and appropriately integrated in clinical practice. CONCLUSIONS: Available information on management in a variety of periprocedural settings is summarized. However, there are areas that lack satisfactory information, which are highlighted throughout the article.

Comparative effectiveness of one versus two-stage sacral neurostimulation device placement.

OBJECTIVE: Sacral neurostimulation (SNS) is an effective third-line treatment for overactive bladder. We sought to compare the cost of standard two-stage SNS device placement to that of a combined one-stage placement using a Markov chain model. METHODS: Costs were defined using Medicare outpatient reimbursement rates. The model was developed as follows: With the two-stage approach, patients underwent initial lead placement with fluoroscopy and those who converted to stage two underwent permanent generator placement week later. Patients who did not convert underwent lead removal. Patients undergoing a one-stage procedure had initial lead and generator placement at the same time. Patients with success underwent no further procedure. Patients without success could opt for generator and lead removal. Cost effectiveness of one versus two-stage placement depended on successful conversion rate. RESULTS: Reimbursement included physician, anesthesia, facility and device fees. In a two-stage procedure, initial cost of lead placement was $6170. With successful conversion, cost of a second procedure with permanent lead and generator placement was $18,474. Patients who failed test phase underwent lead removal for a cost of $2879. In a one-stage procedure approach, initial cost of permanent lead and generator placement was $18,474. Patients with a successful outcome had no additional costs. Patients with an unsuccessful outcome could have the lead and generator removal for a cost of $5758. If the conversion rate from testing phase to permanent placement was greater than 71%, a one-stage approach proved to be cost effective. CONCLUSIONS: Identifying patients with favorable risk factors for success may predict those patients who warrant a one-stage approach.

Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury.

BACKGROUND: Neurogenic bladder (NGB) dysfunction after spinal cord injury (SCI) is generally irreversible. Preliminary animal and human studies have suggested that initiation of sacral neuromodulation (SNM) immediately following SCI can prevent neurogenic detrusor overactivity and preserve bladder capacity and compliance. We designed a multicenter randomized clinical trial to evaluate the effectiveness of early SNM after acute SCI. METHODS/DESIGN: The scientific protocol comprises a multi-site, randomized, non-blinded clinical trial. Sixty acute, acquired SCI patients (30 per arm) will be randomized within 12 weeks of injury. All participants will receive standard care for NGB including anticholinergic medications and usual bladder management strategies. Those randomized to intervention will undergo surgical implantation of the Medtronic PrimeAdvanced Surescan 97,702 Neurostimulator with bilateral tined leads along the S3 nerve root in a single-stage procedure. All patients will undergo fluoroscopic urodynamic testing at study enrollment, 3 months, and 1-year post randomization. The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year. After accounting for a 15% loss to follow-up, we expect 25 evaluable patients per arm (50 total), which will allow detection of a 38% treatment effect. This corresponds to an 84 mL difference in bladder capacity (80% power at a 5% significance level). Additional parameters will be assessed every 3 months with validated SCI-Quality of Life questionnaires and 3-day voiding diaries with pad-weight testing. Quantified secondary outcomes include: patient reported QoL, number of daily catheterizations, incontinence episodes, average catheterization volume, detrusor compliance, presence of urodynamic detrusor overactivity and important clinical outcomes including: hospitalizations, number of symptomatic urinary tract infections, need for further interventions, and bowel and erectile function. DISCUSSION: This research protocol is multi-centered, drawing participants from large referral centers for SCI and has the potential to increase options for bladder management after SCI and add to our knowledge about neuroplasticity in the acute SCI patient. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03083366 1/27/2017.

What is the exact working mechanism of botulinum toxin A and sacral nerve stimulation in the treatment of overactive bladder/detrusor overactivity? ICI-RS 2017.

AIMS: Botulinum toxin A (BTX-A) and sacral nerve stimulation (SNS) are established treatments for overactive bladder (OAB) and are standard of care in refractory cases in international guidelines. Despite long term use over decades their "exact" working mechanisms are not entirely clear. At the ICI-RS meeting in Bristol in 2017 a think tank was convened to address the question. METHODS: The think tank conducted a literature review and an expert consensus meeting focusing on current mechanisms and what could be learned from clinical experience and objective urodynamic data. RESULTS: BTX-A results suggests effects on both filling and voiding parts of the micturition cycle. The salient data in this regard is presented as well as additional studies related to the urothelium and evidence for central effects. Urodynamics have consistently shown increases in bladder capacity, compliance, and reductions in detrusor pressures during filling, however post void residuals also increase in a dose-dependent fashion. During SNS activation of somatic afferents inhibits bladder sensory pathways and reflex bladder hyperactivity. Evidence in cats suggest the inhibition of bladder activity occurs primarily in the CNS by inhibition of the ascending or descending pathways of the spinobulbospinal micturition reflex. Urodynamics have suggested improvement in bladder capacity and reduction in detrusor pressures during filling with little observed effects on voiding parameters. CONCLUSIONS: The working mechanism of BTX-A and SNS is complex. The exact mechanisms are still unknown, although considerable progress has been made in our understanding. Further research proposals are suggested to help further elucidate these mechanisms.

Prospective randomized study evaluating ultrasound versus fluoroscopy guided sacral InterStim® lead placement: A pilot study.

OBJECTIVE: To investigate the use of intraoperative ultrasound during stage I InterStim® sacral lead placement. METHODS: A total of 40 patients were randomly assigned to undergo InterStim® lead placement utilizing fluoroscopy or ultrasound guidance. Patients were blinded for the duration of the study. The surgeon and staff were blinded until after induction of anesthesia. Patients met criteria for refractory overactive bladder, fecal incontinence, or both. The ICIQ-OABqol, OABSS, and FIQL validated questionnaires were used pre- and post-operatively. Primary endpoint was total fluoroscopy time. Secondary endpoints were total radiation exposure and total number of foramen needle skin punctures. RESULTS: Forty patients were enrolled, twenty in the ultrasound and twenty in the fluoroscopy only arm. Mean age was 60 (SD = 14.4) and mean BMI 32 (SD = 7.2). Twenty-seven patients (67.5%) had urinary symptoms, four (10%) fecal incontinence, and nine (22.5%) had mixed symptoms. Radiation exposure time was reduced by 70.5 s (P = 0.002), radiation exposure was decreased by 42.3 mGy (P = 0.017), and the number of needle skin punctures decreased by 3.6 (P = 0.035) with use of ultrasound. Mean OR time in minutes was 55.5 in ultrasound and 58.2 in fluoroscopy group (P = 0.53). There were no statistically significant differences in questionnaire scores between groups. CONCLUSION: Ultrasound guided placement of foramen needle during Stage I sacral neuromodulation results in reduction of radiation exposure to the patient, surgeon, and operating room staff. Further studies are necessary to determine the learning curve and efficacy of this technique.

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.

Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications.

BACKGROUND: Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation. OBJECTIVE: The objective of the study was to compare treatment efficacy and adverse events in women <65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation. STUDY DESIGN: This study was a planned secondary analysis of a multicenter, randomized trial that enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments. The primary outcome was a change in mean daily urgency urinary incontinence episodes on a bladder diary over 6 months. Secondary outcomes included ≥75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events. RESULTS: Both age groups experienced improvement in mean urgency urinary incontinence episodes per day following each treatment. There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227). Among those treated with onabotulinumtoxinA, women <65 years had 3.3-fold greater odds of ≥75% resolution than women ≥65 years (95% confidence interval, 1.56 -7.02). Women <65 years had a greater reduction in Overactive Bladder Questionnaire Short Form symptom bother scores compared with women ≥65 years by 7.49 points (95% confidence interval, -3.23 to -11.74), regardless of treatment group. There was no difference between quality of life improvement by age. Women ≥65 years had more urinary tract infections following onabotulinumtoxinA and sacral neuromodulation (odds ratio, 1.9, 95% confidence interval, 1.2-3.3). There was no evidence of age differences in sacral neuromodulation revision/removal or catheterization following onabotulinumtoxinA treatment. CONCLUSION: Younger women experienced greater absolute continence, symptom improvement, and fewer urinary tract infections; both older and younger women had beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events, and improved quality of life.

Current practice patterns and knowledge among gynecologic surgeons of InterStim® programming after implantation.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to describe surgeons' current practices in InterStim® programming after initial implantation and their knowledge of programming parameters. We hypothesized that surgeons performing their own reprogramming would have increased knowledge. METHODS: We administered a written survey to attendees at the Society of Gynecologic Surgeons Scientific Meeting and analyzed those on which surgeons indicated they offer InterStim® care. The survey queried surgeon characteristics, experience with InterStim® implantation and programming, and clinical opinions regarding reprogramming and tested six knowledge-based questions about programming parameters. Correct response to all six questions was the primary outcome. RESULTS: One hundred and thirty-five of 407 (33%) attendees returned the survey, of which 99 met inclusion criteria. Most respondents (88 of 99; 89%) were between 36 and 60 years, 27 (73%) were women, 76 (77%) practiced in a university setting, and 76 (77%) were trained in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Surgeons who had InterStim® programming training were more likely to perform their own programming [15/46 (32%) vs 6/47 (13%), p = 0.03]. Most answered all knowledge-based questions correctly (62/90, 69%); no surgeon characteristics were significantly associated with this outcome. Most surgeons cited patient comfort (71/80, 89%) and symptom relief (64/80, 80%) as important factors when reprogramming, but no prevalent themes emerged on how and why surgeons change certain programming parameters. CONCLUSIONS: Surgeons who had formal InterStim® programming training are more likely to perform programming themselves. No surgeon characteristic was associated with improved programming knowledge. We found that surgeons prioritize patient comfort and symptoms when deciding to reprogram.

Long-term outcome of sacral neuromodulation in patients with idiopathic nonobstructive urinary retention: Single-center experience.

OBJECTIVE: The objective of this study was to determine the safety and efficacy of sacral neuromodulation (SNM) in patients with idiopathic nonobstructive urinary retention. MATERIALS AND METHODS: We retrospectively reviewed the files of patients who underwent staged neuromodulation for idiopathic nonobstructive urinary retention from 2004 to 2016 at our hospital. Patients who had a 50% improvement in symptoms after 1 week of stage 1 procedure were qualified for permanent device implantation. Patient data were assessed on efficacy and need for intermittent self-catheterization, complications, and operative revision rates. RESULTS: Twenty-seven female patients who underwent SNM therapy were analyzed. The mean age of the patients was 32.5 ± 10.8 years. The mean duration of urinary retention was 3.2 ± 1.7 years. All patients were doing intermittent self-catheterization, but few were able to void <100 ml. Twenty-four (88.8%) of the 27 patients demonstrated a >50% improvement in symptoms and underwent permanent device placement. At a median follow-up of 5.7 ± 3.2 years, 20 (83.3%) of the 24 patients demonstrated sustained improvement rates of >50%. Seventeen (70.83%) of 24 patients could void spontaneously with a mean residual urine of 28.1 ± 24.4 ml (P < 0.001). Three (12.5%) were voiding with significant mean decreasing number of catheterizations from 5.6 ± 2.4 to 1.4 ± 2.1 (P < 0.001). Four (16.6%) had their device explanted. Ten (41.6%) of the 24 patients underwent surgical revision. Most of the adverse events were managed by device reprograming. CONCLUSION: SNM is a highly effective and safe procedure in this subset of the female population with idiopathic refractory nonobstructive urinary retention.

Gastric Electrical Stimulation and Sacral Electrical Stimulation: A Long-Term Follow-Up Study of Dual-Device Treatment.

AIMS: The objective of this study was to investigate sacral electrical stimulation (SES) and gastric electrical stimulation (GES) by comparing upper and lower gastrointestinal (GI) and genitourinary (GU) symptoms and quality of life, before treatment and in the long term after treatment. We hypothesized that dual-device treatment would greatly improve upper and lower gastrointestinal and genitourinary symptoms, as well as quality of life. METHODS: Fifty-four patients who underwent dual-device treatment (GES and SES) were enrolled in this study. Patients who had surpassed 24 months since the second-device insertion were included. Patients were evaluated before and after both devices were implanted and given a symptom questionnaire regarding their upper GI, lower GI, and GU symptoms and their quality of life. RESULTS: With combined treatment, a statistically significant improvement was seen in upper GI, lower GI, and GU symptoms and quality of life. However, fecal incontinence and fecal urgency improvements did not reach statistical significance, likely due to the small sample size. CONCLUSION: The implantation of two stimulators appears to be safe and effective to improve patients' quality of life for those with upper GI symptoms, bowel problems, and bladder dysfunction.

Long term safety of sacral nerve modulation in medicare beneficiaries.

AIMS: Sacral nerve stimulation (SNS) is FDA approved as second-line therapy for both urinary and bowel control. However, there is limited evidence regarding long term safety. We determined adverse events associated with SNS among Medicare beneficiaries. METHODS: We used the 5% national random sample of Medicare claims for 2001-2011 to identify patients. Patients who underwent SNS implantation were identified with Current Procedure Terminology (CPT-4) codes. We determined safety of SNS using analysis of complication occurrences on day of surgery and during 5 years following initial procedure. SAS v9.3 statistical package was used. RESULTS: One thousand four hundred seventy-four patients underwent treatment with SNS in the 5% national sample of Medicare patients within the time period. Representative of real-world patients undergoing SNS surgery, comorbidities included hypertension (69.3%), diabetes (29.4%), chronic pulmonary disease (25.5%), hypothyroidism (25.2%), and depression (22.7%). Few complications occurred on day of surgery. At 90 days, 3.2% of patients had bowel complications, 2.0% urological, 9.4% infectious, and 1.5% stroke. Overall, bowel, neurological health event occurrences were consistent with prior year rates, while infectious events decreased. Of 206 patients who were followed for at least 5 years, 17.3% had devices removed and 11.3% replaced, with 26.1% having at least one of those, leaving 73.9% with original devices. CONCLUSIONS: Urological, infectious, and bowel complication occurrences were low after SNS among Medicare beneficiaries with multiple comorbidities. There were infrequent serious complications like hemorrhage and stroke postoperatively. Although SNS appears safe in this high-risk population, a comprehensive registry will ensure continuous safety.

Outcomes associated with Interstim therapy for medically refractory fecal incontinence.

BACKGROUND: Fecal incontinence is a common, socially debilitating disorder. Initial management involves dietary manipulation with bulking agents or antidiarrheal medications and pelvic floor biofeedback. For patients failing these modalities, traditional surgical approaches are morbid and of variable efficacy. Sacral nerve neuromodulation (Interstim, sacral nerve stimulation) was approved in May 2011 for management of medically refractory fecal incontinence. This report summarizes our experience with this treatment modality. METHODS: A prospectively maintained database from a colorectal specialty practice was reviewed from December 2011 to June 2013. Patient demographics, incontinence etiology, and medical treatment regimens were reviewed. Outcomes for Interstim placement and surgical morbidity were reviewed. RESULTS: A total of 330 patients were evaluated in the clinic for fecal incontinence during the study period. A total of 33 patients (10%) were offered Interstim therapy. The mean age was 63 (39 to 91) years, and 91% (30 of 33) were female. The etiology of the incontinence was obstetric (81%), rectal prolapse (11%), neurogenic (5%), and iatrogenic (3%). The entire group failed either supplemental fiber or antidiarrheal medications and 73% (24 of 33) failed pelvic floor biofeedback. The mean number of bowel accidents/2-week bowel diary before implant was 19 (9 to 52). After phase I implant, 88% (29 of 33) experienced a successful test phase and proceeded to phase II permanent implant. The mean number of bowel accidents/2-week diary postimplant was 3 (0 to 12). A trend toward less severe episodes of incontinence postimplant was observed. There were no complications associated with either the phase I or phase II implant. There were no phase II failures although 1 patient underwent device explant 9 months after phase II implant for chronic pain. CONCLUSIONS: Sacral nerve neuromodulation (Interstim, sacral nerve stimulation) is an effective and efficacious tool for management of medically refractory fecal incontinence that offers a less morbid surgical approach to this problem. Interstim should be considered the first-line surgical approach for medically refractory fecal incontinence.

Cost-effectiveness of novel therapies for overactive bladder.

Overactive bladder is a difficult to treat condition affecting a large proportion of adults resulting in considerable economic impact to society. First-line treatments such as behavioral therapy or antimuscarinic medication are frequently not effective in adequately controlling symptoms or have intolerable side effects. Patients subsequently require second-line therapy including, sacral neuromodulation through either posterior tibial nerve stimulation or sacral nerve stimulation or intra-detrusor injection of Onabotulinumtoxin-A. Mirabegron, a relatively new drug in a separate class, is also employed in the treatment of overactive bladder. The question of which novel therapy to initiate depends on several factors including patient preference, effectiveness and cost. The purpose of this review is to present and discuss the most recent studies pertaining to the cost-effectiveness of novel therapies for overactive bladder.