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Introduction and hypothesis: To confirm the performance and safety of the rechargeable sacral neuromodulation system (InterStim™ Micro) through 2-year follow-up, we report results from the fecal incontinence (FI) cohort through 6-month follow-up.Methods: Eligible patients were enrolled following successful therapy evaluation and implant. Participants completed bowel diaries and questionnaires at baseline, 3, and 6 months post-implant. The primary objective was improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline. Safety was evaluated by collection of reportable adverse events (AE).Results: Of 53 patients implanted, 90.6% were female and the mean (± SD) age was 58 ± 11 years. There was a statistically significant improvement in CCIS at 3 months vs baseline, with a mean change of -4 ± 3.7 (p < 0.001, n = 52). This improvement was maintained at 6 months, with a mean change of -4.0 ± 3.58 (n = 52). The mean change in Fecal Incontinence Quality of Life (FIQoL) at 3 months was 3.2 ± 2.8 (n = 52) and 3.6 ± 2.9 (n = 53) at 6 months. On the Patient Global Impression of Improvement (PGI-I), 94% (n = 52) and 90.6% (n = 53) of participants reported their condition was better at 3- and 6-month follow-up compared to baseline, respectively. The incidence of device-, procedure-, or therapy-related AEs in enrolled participants was 18.9% (10/53); among these was one serious related AE. There were no unanticipated adverse device effects.Conclusions: The primary objective of the FI cohort was met, with statistically significant improvement in CCIS and patient-reported outcomes. These data confirm clinical performance and safety through 6 months post-implant.Clinical trial registration: NCT04506866.

Introduction and hypothesisDescribe a novel technique for retrieval of the Interstim lead in part based on techniques used in massage therapy.MethodsRetrospective 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.ResultsSixty 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.ConclusionsLead 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.

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.

Purpose of Review The purpose of this review is to evaluate the evidence regarding the efficacy and safety of implantable sacral neuromodulation (SNM) in pediatric patients with voiding dysfunction. The aim is to address the lack of substantial supporting data for SNM use in pediatric populations and provide insights into its potential as a treatment option. Recent Findings Recent research indicates that SNM can be an effective treatment for pediatric voiding dysfunction when conventional therapies fail. A systematic review of eight studies published between 2008 and 2021, involving 427 pediatric patients, revealed promising outcomes. These included a 68% improvement rate in urinary symptoms, with 39% experiencing complete resolution. Urodynamic improvements were also noted, with reductions in detrusor pressure, uninhibited detrusor contractions, and postvoid residual volume. However, complications such as lead issues, device migration or erosion, pain, and IPG replacement were observed in a notable percentage of cases, necessitating reoperation in some instances. Summary In conclusion, implantable SNM emerges as a potentially effective treatment for pediatric voiding dysfunction, improving urinary symptoms and quality of life. However, the presence of complications underscores the importance of careful risk-benefit assessment for individual patients. Further research is warranted to address varying success rates and complications, emphasizing the need for improved trial quality in this field. The findings of this review highlight the potential impact of SNM in pediatric populations and underscore the need for continued investigation and refinement of this therapeutic approach.

To detect possible effects of magnetic resonance imaging (MRI) scans on the function of an InterStim Twin sacral nerve stimulation (SNS) device and on patient's health. There is no authorization for MRI scans in InterStim Twin SNS at all. 10 patients with Interstim Twin sacral nerve stimulator implants underwent a singular MRI scan. Before the MRI was performed, the SNS device function was evaluated and the device was deactivated be the implanting urologist. A continuous monitoring took place during MRI procedure. Micturition-time chart pre- and post MRI procedures were conducted. After the MRI session was completed, the implanted device was examined once more and reactivated, function then was evaluated. A total of 10 patients required MRI examinations in 8 different body regions. No patient reported pain or discomfort during and after the MRI scan. After reactivation of the InterStim Twin device following the MRI, impedances and stimulation amplitude, micturition frequency, urgency, and incontinence episodes remained stable. No significant differences between pre- and post MRI were found (p>0.05). This is the first report of patients successfully undergoing a MRI scan despite a previously implanted Interstim Twin sacral nerve stimulator. No negative effect of SNS function or negative side effects for the patients were observed.

Neuromodulation is an important treatment modality for a variety of pelvic floor disorders. Percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) are currently the two approved methods for delivering this therapy. Percutaneous tibial nerve stimulation is a minimally invasive office-based procedure that has shown efficacy in the treatment of overactive bladder, fecal incontinence, and pelvic pain. It has the advantage of minimal side effects but is limited by the need for patients to make weekly office visits to receive the series of treatments. Sacral neuromodulation uses an implanted device that stimulates the S3 nerve root and can improve symptoms of overactive bladder, non-obstructive urinary retention, fecal incontinence, and pelvic pain. This paper will review the most recent literature regarding this topic and discuss their advantages and limitations and recent innovations in their use.

Introduction and hypothesisThe 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.MethodsWe 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.ResultsOne 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.ConclusionsSurgeons 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.

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.

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. 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. 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. 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.