Concomitant Sacral Neuromodulation and Gynecologic Surgery: A Single-Institution Experience.

AIMS: Sacral Neuromodulation (SNM) is a safe and minimally invasive treatment for urinary and fecal pelvic floor disorders (PFDs). With a high prevalence of women reporting multiple PFDs, knowledge regarding concomitant surgery may inform optimal patient care. Our literature search did not identify any published data on this topic, thus we sought to report our experience with concomitant SNM and gynecologic surgery. Our primary objective was to identify the rate of adverse events among cases. Secondarily, we reviewed the anesthetics used to identify potential associations when performing combined surgery. MATERIALS AND METHODS: This was retrospective case series of women undergoing SNM at a single academic center from 2012 to 2018. Cases were identified using current procedural terminology codes for SNM and common gynecologic procedures. These electronic medical records were reviewed to identify cases that occurred concomitantly in addition to obtaining demographics, adverse events, type of anesthesia, and overnight hospital stay. Descriptive data analysis was performed with Excel. RESULTS: Of 200 identified cases of SNM, 15 (7.5%) were concomitantly performed with another procedure. Most concomitant surgeries occurred with insertion of implantable pulse generator. Three minor adverse events occurred: two urinary tract infections and one occurrence of urinary retention. Eight (53%) cases were performed under general anesthesia while seven (46%) received monitored sedation. CONCLUSIONS: No serious adverse events or anesthesia-related complications were identified in this series. While general anesthesia was used more often, it was in accordance with our standard practice for the gynecologic procedures. This study supports the safety of concomitant gynecologic and SNM surgery.

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.

Stimulation latency and comparison of cycling regimens in women using sacral neuromodulation.

AIMS: In this two-part study, we sought to define how long sacral neuromodulation users with overactive bladder should trial a new setting before attributing symptoms to that setting. Subsequently, we evaluated patient preferences of variable stimulation regimens. METHODS: In the initial phase of this prospective pilot study, participants' devices were turned off and later reactivated; time to symptom recurrence and resolution were recorded. In phase two, participants trialed four settings in a masked fashion with random order. After unmasking, participants chose their preferred setting and were followed 1 year. RESULTS: Twelve subjects completed phase one. With the device off, the mean time to symptom recurrence was 11.25 days. Mean time to symptom regression following reactivation was 6.42 days. Combined, the 90th percentile was 15 days for symptoms to reflect the device's new setting. Among 23 women completing part two, the most popular setting at the time of unmasking was a 1-hr on, 2-hr off cycled setting chosen by 7 (30%) participants. According to published estimates of battery longevity, 14 (61%) participants chose a more energy-conserving setting at the time of unmasking. The mean difference in estimated battery longevity between the chosen and baseline regimens was 14.5 months. These gains diminished in the following year with clinical changes in device settings by patients and providers. CONCLUSIONS: Sacral neuromodulation patients should allow a 2-week trial before attributing symptoms to a new setting. With additional information, many opt for energy-conserving settings. A 1-hr on, 2-hr off regimen warrants further study. Neurourol. Urodynam. 36:486-489, 2017. © 2016 Wiley Periodicals, Inc.

Cost profiles and budget impact of rechargeable versus non-rechargeable sacral neuromodulation devices in the treatment of overactive bladder syndrome.

OBJECTIVES: Sacral neuromodulation (SNM) is a guideline-recommended third-line treatment option for managing overactive bladder. Current SNM devices are not rechargeable, and require neurostimulator replacement every 3-6 years. Our study objective was to assess potential cost effects to payers of adopting a rechargeable SNM neurostimulator device. METHODS: We constructed a cost-consequence model to estimate the costs of long-term SNM-treatment with a rechargeable versus non-rechargeable device. Costs were considered from the payer perspective at 2015 reimbursement levels. Adverse events, therapy discontinuation, and programming rates were based on the latest published data. Neurostimulator longevity was assumed to be 4.4 and 10.0 years for non-rechargeable and rechargeable devices, respectively. A 15-year horizon was modeled, with costs discounted at 3% per year. Total budget impact to the United States healthcare system was estimated based on the computed per-patient cost findings. RESULTS: Over the 15-year horizon, per-patient cost of treatment with a non-rechargeable device was $64,111 versus $36,990 with a rechargeable device, resulting in estimated payer cost savings of $27,121. These cost savings were found to be robust across a wide range of scenarios. Longer analysis horizon, younger patient age, and longer rechargeable neurostimulator lifetime were associated with increased cost savings. Over a 15-year horizon, adoption of a rechargeable device strategy was projected to save the United States healthcare system up to $12 billion. CONCLUSIONS: At current reimbursement rates, our analysis suggests that rechargeable neurostimulator SNM technology for managing overactive bladder syndrome may deliver significant cost savings to payers over the course of treatment. Neurourol. Urodynam. 36:727-733, 2017. © 2016 Wiley Periodicals, Inc.

Sacral nerve stimulation for the treatment of refractory voiding and bowel dysfunction.

Sacral nerve stimulation, sometimes referred to as a "pacemaker for the bladder and bowels" delivers nonpainful, electrical pulses to the sacral nerves to improve or restore function. A relatively simple procedure works via a complex mechanism to modulate the reflexes that influence the bladder, bowels, sphincters, and pelvic floor. Current approved indications include urinary urge incontinence, urgency-frequency, nonobstructive urinary retention, and fecal incontinence. The history, mechanism of action, evolution, and landmark literature for this treatment modality are reviewed.

Randomized prospective crossover study of interstim lead wire placement with curved versus straight stylet.

AIMS: To assess whether InterStim lead wire placement with the curved stylet achieves motor response at lower amplitudes compared to straight stylet use. METHODS: This was a prospective, randomized, crossover study of patients scheduled for InterStim lead wire placement. All patients underwent lead wire testing with both the curved and straight stylets. Patients were randomized to determine stylet order, and then crossed-over to the alternate. Intra-operatively, the amplitude achieving motor response at each electrode was recorded. The stylet with lowest overall amplitudes was used for final placement. Primary outcome measure was amplitude requirement in the two deepest (0 and 1) electrodes. Secondary outcomes included amplitudes at the number 2 and 3 electrodes, combined amplitudes, stylet order, and adverse outcomes. RESULTS: Forty-two patients were enrolled, 40 of whom were included in the final analysis. Mean age was 69 years (SD = 12.8) and mean BMI 27 (SD = 5.6). Indications for placement included: urge urinary incontinence (N = 26), urge/frequency (N = 25), non-obstructive urinary retention (N = 5), and fecal incontinence (N = 10). There were no significant differences between randomized groups. Regardless of order, the curved stylet achieved a motor response at lower amplitudes in the deepest electrodes (P < 0.001). Combined amplitudes of all electrodes were also significantly lower with the curved stylet (P < 0.001). Subsequently, 88% underwent final "optimal" placement with curved stylet (N = 35). CONCLUSIONS: The curved stylet for InterStim lead wire placement consistently achieved motor response at lower amplitudes. A brief intra-operative exchange of stylets represents a minor procedural alteration that could maximize Implantable Pulse Generator battery life and facilitate programming.

In vivo recovery of the injured anal sphincter after repair and injection of myogenic stem cells: an experimental model.

OBJECTIVE: This study aims to evaluate in vivo function of the external anal sphincter after transection and repair augmented with myogenic stem cells, and to establish normative electromyography parameters of the rodent external anal sphincter. DESIGN AND SETTING: Thirty-three Sprague-Dawley rodents underwent baseline needle electromyography of the external anal sphincter. Motor unit action potentials were obtained and normative parameters established. Animals were randomly assigned to a myogenic stem cell group (n = 24) or control group (n = 9). All underwent proctoepisiotomy. The control group underwent layered repair with phosphate-buffered saline injection to the external anal sphincter. The treatment group underwent identical repair with injection of myogenic stem cells 5.0 × 10. Baseline anal pressure recordings were collected and repeated 2 weeks postintervention, and electromyography was repeated at 2 and 4 weeks. Groups were compared across 3 time points with the use of repeated measures ANOVA. MAIN OUTCOME MEASURES: The primary outcomes measured were the functional recovery of rat anal sphincters after stem cell transplantation as assessed by objective electromyography and anal pressure measures. RESULTS: A mean of 17 motor unit action potentials were sampled per animal. At 2 weeks postrepair, there was a significant difference between control and transplant groups with respect to amplitude, duration, turns, and phases (p < 0.01 for each). No significant electromyography differences were seen at 4 weeks. Resting and peak anal pressures declined significantly at 2 weeks postinjury in the control but not in the stem cell group. LIMITATIONS: Use of a murine animal population limited the subjective feedback and wider applicability. CONCLUSIONS: In vivo functional studies show recovery of anal sphincter pressures and electromyography to preinjury levels by day 14 in the myogenic stem cell group but not controls. At 4 weeks, all electromyography parameters returned to baseline irrespective of group. Restoration of function may be accelerated by the transplantation of myogenic stem cells and associated trophic factors.

Natural orifice vaginal sacrocolpopexy (NOVaS): a cadaver feasibility study.

INTRODUCTION AND HYPOTHESIS: The primary objective was to determine the feasibility of a vaginal approach to sacrocolpopexy using a cadaver model. Secondary objectives were to measure the distance from the vaginal introitus to the sacrum and distances of the sacral fixation elements to other vital structures. METHODS: Fourteen fresh-frozen cadavers were used. Specialized instruments were developed to optimize visualization and facilitate performance of the procedure. RESULTS: Five cadavers had a transperineal approach (an approach found unfeasible), and eight of the remaining nine had complete or partial completion of the transvaginal approach. The mean distance from the introitus to the promontory was 14.6 cm (12-16.5 cm). The mean distance from the sacral fixation elements to the aorta was 5.2 cm; common iliac artery, 3.5 cm; internal iliac artery, 3.25 cm; middle sacral artery, 1.75 cm, and ureters, 3.5 cm. The position of the sacral fixation elements was consistently at the level of S1-2. CONCLUSION: Vaginal sacrocolpopexy is feasible in a cadaver model.

Neuromodulation and the role of electrodiagnostic techniques.

Electrodiagnostic techniques have been utilized in surgery since the early 1960s. These techniques have been primarily used in neurosurgery; however, with the introduction of neuromodulation for voiding dysfunction, these techniques have now found their way into the field of female pelvic medicine. This article will review techniques applicable to evaluate pelvic floor function as it relates to neuromodulation. It will also review the literature describing how these techniques are used to help determine appropriate candidates as well as improve surgical outcomes. A PubMed search was conducted using the terms neuromodulation, Interstim, electrodiagnosis, electrodiagnostic techniques, electromyography with limits to the pelvic floor, and voiding dysfunction. Eight articles and three abstracts were found that directly related to the use of electrodiagnostic techniques as they apply to neuromodulation. Electrodiagnostic techniques may play a role in helping predict appropriate candidates for neuromodulation as well as improve surgical outcomes.

Effects of the incontinence dish pessary on urethral support and urodynamic parameters.

OBJECTIVE: To evaluate the effects of the incontinence dish pessary (IDP) on urethral mobility and urodynamics. STUDY DESIGN: Prospective study of women with symptoms of stress incontinence. Q-tip test was performed recording the resting and straining angles with and without an IDP. Changes in resting and straining angles were calculated. Those with evidence of urodynamic stress incontinence had urodynamics with the IDP. Paired t-test was used to compare the difference in Q-tip angles with and without the pessary. RESULTS: Mean Q-tip straining angle without and with the pessary, respectively, was 57.8 (+19.5) and 34.4 (+29.7). Mean change was 23.5 (+18.5) P < .00001. Maximum urethral closure pressure (MUCP) was significantly increased by 19.7 cm H(2)0 P < .001. Overall, 60% of the subjects did not leak with the IDP. CONCLUSION: The IDP eliminates >60% of USI. The mechanism of action may be a combination of improved UVJ support and increased MUCP.

Reconstructive pelvic surgery and plastic surgery: safety and efficacy of combined surgery.

OBJECTIVE: The purpose of this study was to address the safety of combining aesthetic and pelvic floor reconstructive procedures. STUDY DESIGN: Fifty-four subjects were included in a case-control study; 18 patients undergoing combined pelvic and plastic reconstructive surgery, age and procedure matched to 18 pelvic surgery and 18 plastic surgery only controls. Chi-square, t test, and Kruskal-Wallis analysis were used to compare the estimated blood loss (EBL), body mass index (BMI), hospital days, operative times, and complications between the groups. RESULTS: No differences were seen with regards to age, BMI, or EBL. There was, however, a significant increase in minor complications and hospital stay after combined procedures relative to the pelvic surgery control group but not the aesthetic control group. Operative times were only greater during combined procedures relative to isolated pelvic floor procedures. CONCLUSION: Combining pelvic and aesthetic procedures may increase complications, operative times, and length of hospital stay when compared to pelvic reconstructive surgery alone.

Sacral Nerve Stimulation as a Therapy for Patients With Refractory Voiding and Bowel Dysfunction.

Sacral nerve stimulation delivers nonpainful electrical pulses to the sacral nerves that modulate the reflexes that control the bladder, bowels, and pelvic floor musculature. This relatively simple procedure was generated to improve and restore function in patients with a variety of pelvic floor disorders. Currently this therapy is approved for use in patients with urgency urinary incontinence, urinary urgency-frequency, nonobstructive urinary retention, and fecal incontinence. This review includes the history of this treatment modality, explains the mechanism of action, and describes the procedure for implantation of this device. Additionally, advancements in this treatment over the past two decades and landmark literature to date regarding sacral nerve stimulation are reviewed. Current literature regarding off-label uses of this treatment modality for a variety of pelvic floor disorders is also discussed.

Sacral nerve neuromodulation in patients with cardiac pacemakers.

OBJECTIVE: The objective of the study was to describe our experience using sacral nerve neuromodulation for urinary urgency, frequency, and urge incontinence in patients with cardiac pacemakers. STUDY DESIGN: The study was a case series of 3 patients with cardiac pacemakers who underwent sacral nerve stimulation for refractory urgency, frequency, and urge incontinence. RESULTS: Each patient underwent placement of an InterStim lead wire in the S3 foramen. Intraoperative cardiac monitoring revealed no evidence of cross-interference, even at maximum stimulation. Postoperative telemetry for 24 hours did not reveal any interference from the sacral nerve stimulator. All patients had a greater than 50% reduction in incontinence episodes during their test trial and underwent placement of the InterStim implantable pulse generator (IPG). Intraoperative and postoperative IPG programming was done with cardiac monitoring; no interaction was detectable. CONCLUSION: Sacral nerve stimulation appears to be safe in the presence of a cardiac pacemaker.

Sacral nerve neuromodulation in patients with underlying neurologic disease.

OBJECTIVE: Sacral nerve neuromodulation (SNS) is an effective treatment for lower urinary tract dysfunction. Many underlying neurologic processes affect lower urinary tract function. We present results of SNS in patients with underlying neurologic dysfunction. STUDY DESIGN: This is a retrospective case series of 33 patients with neurologic disease and lower urinary tract dysfunction who underwent an InterStim stimulation procedure. Results were evaluated by pre- and postoperative voiding diaries. Success was defined as greater than 50% improvement. RESULTS: Twenty-eight of 33 patients (85%) underwent implantation: 13 of 16 (81%) multiple sclerosis, 4 of 6 (67%) Parkinson disease, and 11 of 11 (100%) other neurologic disorders. Incontinence episodes per 24 hours decreased 68%, number of voids per 24 hours decreased 43%, nocturia decreased 70%, and there was a 58% reduction in intermittent self-catheterization per 24 hours. Ninety-three percent reported overall satisfaction. CONCLUSION: Sacral nerve neuromodulation is an effective treatment for lower urinary tract dysfunction in patients with underlying neurologic disease.

Use of composite grafts in abdominal sacrocolpopexy.

OBJECTIVE: : The ideal graft material for pelvic reconstructive surgery remains undetermined. The purpose of this study was to present data on novel composite biologic/synthetic grafts during use in abdominal sacrocolpopexy. METHODS: : A case series of 90 patients undergoing abdominal sacrocolpopexy with composite biologic/synthetic grafts was conducted. The primary outcome was graft erosion. Assuming a 3% risk of reoperation for mesh erosion, the number needed to treat with a composite graft in order to avoid erosion risk from a synthetic-only graft was calculated. The cost of a composite graft was compared to reoperation costs for mesh erosion of a synthetic-only graft. RESULTS: : Zero patients (N = 90) undergoing abdominal sacrocolpopexy with a composite biologic/synthetic graft experienced graft erosion. Based on existing data, thirty-three patients would need to be treated with a composite graft to avoid one mesh erosion from a synthetic-only graft. If a $500 composite graft is used, the cost of reoperation performed abdominally is higher. CONCLUSIONS: : This study introduces a novel biologic/synthetic composite graft that offers the advantage of low erosion risk during use in abdominal sacrocolpopexy. Combined grafts may also be cost-effective. Future research should focus on exploring the role of these durable, yet low erosion risk grafts to potentially promote improved safety for our patients and cost savings for society.

Lynx midurethral sling system: a 1-year prospective study on efficacy and safety.

The objective of this study is to determine the outcomes for the Lynx midurethral sling system in the treatment of urodynamic stress incontinence (USI). Prospective study of 118 subjects who underwent a Lynx midurethral sling procedure for USI. Subjects were considered cured if they were subjectively dry by history and objectively dry by standing stress test. Intraoperative and postoperative complications were documented. Complete information was available on 102 (86%) subjects at 1 year. Ninety-two patients were considered cured, and ten were failures. There were four intraoperative bladder perforations and five (4.2%) erosions. Two patients developed urinary retention with one resolving at 31 days and the other undergoing subsequent takedown at 6 months. Both remain dry at 12 months. The Lynx midurethral sling system shows high subjective and objective success rates for the treatment of USI at 1 year with low rates of intraoperative and postoperative complications.