Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

Strategies for Difficult Fluoroscopic Landmarking During Sacral Neuromodulation Lead Placement.

OBJECTIVES: Fluoroscopic guidance is a key tool used in combination with sensory and motor testing to ensure optimal sacral neuromodulation lead placement. The objectives of this video are to briefly review bony landmarks for fluoroscopic imaging and provide strategies to overcome common obstacles during fluoroscopic mapping for sacral neuromodulation lead placement. METHODS: Our video is divided into 2 parts. First, we review anatomic landmarks in anterior-posterior (AP) fluoroscopic imaging for identification of the sacrum and the medial edge of the bilateral sacral foramina. We then provide a series of nonideal fluoroscopic images, explaining the cause of the difficult interpretation and strategies to overcome these obstacles. In the second half, we similarly review the identification of S3 and optimal needle angle trajectory during lateral fluoroscopic imaging. We again provide a series of nonideal imaging examples to highlight strategies for needle placement in difficult cases. RESULTS: We provide an overview of normal fluoroscopic landmarks for both AP and lateral fluoroscopic imaging during sacral neuromodulation lead placement, along with a series of 6 nonideal examples. Strategies for overcoming barriers to identification of bony anatomy on fluoroscopy are provided in the context of these examples. CONCLUSION: While appropriate patient preparation and positioning are important to optimize fluoroscopic guidance during sacral neuromodulation lead placement, patient anatomy and other factors often obscure or distort expected anatomic landmarks. We demonstrate our approach to overcoming common fluoroscopic obstacles and provide strategies for improvement of operative efficiency. These strategies can be combined with other intraoperative information such as tactile feedback, additional fluoroscopic views, and intraoperative complex nerve mapping to help optimize sacral neuromodulation lead placement and improve operative efficiency.

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

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Sacral neuromodulation: troubleshooting needle placement.

INTRODUCTION AND HYPOTHESIS: The objective was to develop an instructional video that utilizes fluoroscopic images and anatomical landmarks to increase the surgeon's ability to troubleshoot optimal placement of the foramen needle and lead during a stage I sacral neuromodulation (SNM) procedure. METHODS: Eight different examples of suboptimal foramen needle placement with subsequent corrections during a SNM procedure were performed and recorded on a fresh female cadaver. RESULTS: Fluoroscopic images were obtained during the procedure, and illustrations of the posterior aspect of the sacrum highlighting the S3 foramina and nerve are shown for anatomical comparison. CONCLUSIONS: This video demonstrates how to efficiently identify and correct suboptimal foramen needle placement in order to obtain optimal lead placement during an SNM procedure. Understanding the relationship between the bony landmarks on fluoroscopy and the S3 nerve and foramen are important in order to understand how to correct a suboptimal foramen needle and thus achieve optimal lead placement.

Sacral neuromodulation: sacral anatomy and optimal lead placement.

INTRODUCTION AND HYPOSTHESIS: To develop an instructional video that correlates cadaveric anatomy with fluoroscopic images to assist in conceptualization of optimal placement of the foramen needle and lead to complete an efficient and successful sacral neuromodulation (SNM) procedure. METHODS: A SNM procedure was performed and recorded on a fresh female cadaver. Fluoroscopic images were obtained during the procedure to highlight the bony relationships to the S3 foramen and nerve. Dissection of the anterior and posterior sacrum was completed to highlight the tract of the S3 nerve. Techniques to increase the likelihood of optimal foramen needle and thus lead placement were highlighted. CONCLUSIONS: This video demonstrates how achieving optimal foramen needle placement within the S3 foramen is key to optimal lead placement. Understanding the relationship of the bony landmarks on fluoroscopy to the S3 nerve and foramen, seen in the cadaveric dissections, are important in understanding how to achieve optimal lead placement. This optimization should lead to decreased operating room time, maximization of programming options, and decreased amplitude requirements.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function.

BACKGROUND: Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA or sacral neuromodulation. Little data exists on the comparative effects of treatment of refractory urgency urinary incontinence on other pelvic floor complaints, such as bowel and sexual function. OBJECTIVE: The objective of this study was to compare the impact of these treatments on fecal incontinence and sexual symptoms. METHODS: This was a planned supplemental analysis of a randomized trial in women with refractory urgency urinary incontinence treated with onabotulinumtoxinA (n = 190) or sacral neuromodulation (n = 174). Fecal incontinence and sexual symptoms were assessed at baseline and at 6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark's (Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The PISQ-IR allows measurement of sexual symptoms in both sexually active and non-sexually active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures mixed model to estimate change in all parameters from baseline while adjusting for the baseline score. A subgroup analysis of women with clinically significant bowel symptoms was conducted based on baseline Vaizey score of ≥12. RESULTS: At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms and were not different between onabotulinumtoxinA and sacral neuromodulation groups (7.6 ± 5.3 vs 6.6 ± 4.9, P = .07). The proportion of sexually active women (56% vs 63%, P = .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P = .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA and sacral neuromodulation groups at baseline. There was no difference between women treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6 months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9, 95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2, P = .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7 vs 2.2, 95% confidence interval 0.7 to 3.7, P = .99). There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months. Similar findings were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA = 33 and sacral neuromodulation = 22) with clinically significant fecal incontinence at baseline (Vaizey score ≥12), there was a clinically meaningful improvement in symptoms in both groups from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6, 95% confidence interval -8.5 to -2.6, P = .8). CONCLUSION: There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.

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.

Multiple Reflex Pathways Contribute to Bladder Activation by Intraurethral Stimulation in Persons With Spinal Cord Injury.

OBJECTIVE: To measure the urodynamic effects of electrical co-stimulation of 2 individual sites in the proximal and distal urethra in persons with spinal cord injury (SCI). This work was motivated by preclinical findings that selective co-stimulation of the cranial urethral sensory nerve and the dorsal genital nerve, which innervate the proximal and distal portions of the urethra, respectively, increased reflex bladder activation and voiding efficiency. MATERIALS AND METHODS: Electrical co-stimulation of urethral afferents was conducted in persons with chronic SCI during urodynamics. The effects of different frequencies of intraurethral stimulation at multiple urethral locations on bladder pressure and pelvic floor electromyographic activity were measured. RESULTS: Electromyographic activity indicated that multiple reflex pathways were recruited through stimulation that contributed to bladder activation. The size of reflex bladder contractions evoked by stimulation was dependent on stimulation location or reflex activated and stimulation frequency. CONCLUSION: Pudendal nerve afferents are a promising target to restore lost bladder control, as stimulation with different frequencies may be used to treat urinary incontinence and increase continent volumes or to generate stimulation-evoked bladder contractions for on-demand voiding. This work identified that co-stimulation of multiple afferent reflex pathways can enhance activation of spinal circuits and may enable improved bladder emptying in SCI when stimulation of a single pathway is not sufficient.

Urinary Biomarkers in Women with Refractory Urgency Urinary Incontinence Randomized to Sacral Neuromodulation versus OnabotulinumtoxinA Compared to Controls.

PURPOSE: We measured urinary biomarker levels in women with refractory urgency urinary incontinence and controls at baseline and 6 months after treatment with sacral neuromodulation or intradetrusor injection of onabotulinumtoxinA. We also assessed the association of baseline biomarkers with posttreatment urgency urinary incontinence episodes and overactive bladder symptom bother outcomes. MATERIALS AND METHODS: First morning urine samples were collected from consented trial participants and age matched women without urgency urinary incontinence. Biomarkers reflecting general inflammation, neuroinflammation, afferent neurotransmitters and tissue remodeling were measured using standardized enzyme-linked immunosorbent assay and activity assays as appropriate. Symptom bother was assessed by the overactive bladder questionnaire and urgency urinary incontinence episodes were determined by bladder diary. Linear models were used to examine differences in mean biomarker levels and the change in urgency urinary incontinence episodes and symptom bother between baseline and 6 months. Modest evidence of a potential association was represented by p ≤0.01 and p ≤0.004 represented moderate evidence of an association with outcomes. RESULTS: Baseline biomarker levels differed little between cases and controls except tropoelastin (p = 0.001) and N-terminal telopeptide collagen type 1 (p <0.001). Changes in biomarker levels 6 months after intervention included decreases in collagenase (p <0.001) in both treatment groups and increases in interleukin-8 (p = 0.002) and matrix metalloprotease-9 (p <0.001) in the onabotulinumtoxinA group. Higher baseline calcitonin gene-related peptide across both treatments (p = 0.007) and nerve growth factor in the onabotulinumtoxinA arm (p = 0.007) were associated with less reduction in overactive bladder symptom bother. CONCLUSIONS: Refractory urgency urinary incontinence is a complex condition. These data suggest that matrix remodeling and neuropeptide mediation may be involved in its pathophysiological mechanisms and response to treatment.

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

Posterior tibial nerve stimulation for the treatment of fecal incontinence: a systematic evidence review.

IMPORTANCE AND OBJECTIVES: Posterior tibial nerve stimulation (PTNS) is a potential emerging therapy for fecal incontinence (FI). The aim of this study was to systematically review the literature regarding the efficacy of PTNS as a treatment of FI. EVIDENCE ACQUISITION: We searched MEDLINE/PubMed, EMBASE, and Cochrane databases from inception through November 2013. We included English-language full-text articles reporting outcomes for FI with either percutaneous PTNS or transcutaneous techniques (transcutaneous electrical nerve stimulation). We used the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system to assess study quality. RESULTS: Our search yielded 1154 citations; 129 abstracts and 17 articles were included for full-text review. There were 13 case series and 4 randomized controlled trials. Fifteen studies were of low quality, none were of fair quality, and 2 studies were of good quality based on the Grades of Recommendation, Assessment, Development, and Evaluation system. In total, 745 subjects were studied, and of those, 90% were women and 10% were men. Studies involved percutaneous PTNS in 57% (428/745) of the subjects, transcutaneous electrical nerve stimulation in 30% (223/745), and sham technique in 13% (94/745). Therapy frequency, maintenance therapy, and follow-up time varied across studies. Eleven studies assessed FI episodes and bowel movement deferment time; all but 1 showed statistical improvement after therapy. Ten of the 11 studies that used the Cleveland Clinic Florida Fecal Incontinence score reported statistically significantly improved scores after treatment. CONCLUSIONS AND RELEVANCE: Multiple low-quality studies show improvement in FI after PTNS. High-quality studies with comparison groups and clinically meaningful outcome measures would further establish the utility of PTNS for FI.

Electrical stimulation for the treatment of lower urinary tract dysfunction after spinal cord injury.

Electrical stimulation for bladder control is an alternative to traditional methods of treating neurogenic lower urinary tract dysfunction (NLUTD) resulting from spinal cord injury (SCI). In this review, we systematically discuss the neurophysiology of bladder dysfunction following SCI and the applications of electrical stimulation for bladder control following SCI, spanning from historic clinical approaches to recent pre-clinical studies that offer promising new strategies that may improve the feasibility and success of electrical stimulation therapy in patients with SCI. Electrical stimulation provides a unique opportunity to control bladder function by exploiting neural control mechanisms. Our understanding of the applications and limitations of electrical stimulation for bladder control has improved due to many pre-clinical studies performed in animals and translational clinical studies. Techniques that have emerged as possible opportunities to control bladder function include pudendal nerve stimulation and novel methods of stimulation, such as high frequency nerve block. Further development of novel applications of electrical stimulation will drive progress towards effective therapy for SCI. The optimal solution for restoration of bladder control may encompass a combination of efficient, targeted electrical stimulation, possibly at multiple locations, and pharmacological treatment to enhance symptom control.

Impact of staged InterStim implantation on the postoperative activities of daily living and pain.

OBJECTIVES: To evaluate the short-term effects of staged InterStim implantation on activities of daily living (ADL) and pain. METHODS: This prospective study assessed women undergoing staged InterStim implantation. The Older Americans Resources and Services Program Multidimensional Functional Assessment Questionnaire asked participants about their ability to complete activities without help or what help they needed following stage I lead placement and stage II neurostimulator implantation. Narcotic use and a visual analog scale (VAS) for pain were recorded daily. RESULTS: Thirty-eight women underwent stage I with 33 (86.8%) progressing to stage II. On stage I postoperative day (POD) 2, more women required help shopping compared with baseline (40 vs 17%, p < 0.004). The median pain score increased on Stage I POD1 (P < 0.001) and the use of narcotics increased on POD1 and 2 compared with baseline (50% vs 14%, p = 0.001). The same trends were seen following stage II. CONCLUSIONS: Staged InterStim implantation has minimal impact on ADL, pain or narcotic requirements.

Does obesity impact the success of an InterStim test phase for the treatment of refractory urge urinary incontinence in female patients?

OBJECTIVES: Some providers believe obesity may be a relative contraindication for InterStim; however, the relationship between obesity and treatment outcome has not been evaluated. Our objectives were to compare the test phase (stage 1) success and complications of obese versus nonobese women undergoing a 2-stage InterStim procedure for refractory urge urinary incontinence (UUI). METHODS: We conducted a retrospective cohort study of obese and nonobese women who underwent stage 1 InterStim for refractory UUI. We compared the stage 1 success, defined as undergoing stage 2 generator implantation after demonstrating improvement of 50% or greater during test phase and intraoperative and postoperative complications within 1 year between obese and nonobese cohorts. RESULTS: Of 149 subjects, 80 (53.7%) were obese (body mass index, 37.3±5.87 kg/mg), and 69 (46.3%) were nonobese (body mass index, 25.6±2.82 kg/m). The overall stage 1 success was 81%. No statistically significant difference existed in stage 1 success between obese and nonobese cohorts (83% vs 78%, P=0.52). In a logistic regression model controlling for obesity, age, preoperative incontinence episodes per 24 hours, psychiatric diagnoses, arthritis, and diabetes mellitus, age per decade was the only variable significantly associated with stage 1 InterStim success (odds ratio, 0.61; 95% confidence interval, 0.39-0.96). Complications were also similar between cohorts (obese 20% vs nonobese 13%, P=0.26). CONCLUSIONS: In women undergoing staged InterStim therapy, stage 1 success and complications were similar between obese versus nonobese women. These data suggest that obesity should not be considered a limiting factor when determining whether a patient is a candidate for InterStim therapy for treatment of refractory UUI.

The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review.

INTRODUCTION AND HYPOTHESIS: Posterior tibial nerve stimulation (PTNS) is a percutaneous method of peripheral, sacral neuromodulation. Its current use is limited; however, published data suggest PTNS may be an effective treatment for overactive bladder (OAB). METHODS: We systematically reviewed the literature on PTNS for treatment of idiopathic OAB in women from January 2000 to August 2010 published in English in MEDLINE/PubMed, Embase, and Cochrane databases. We included randomized controlled trials or observational studies reporting objective outcome measures with the use of either the Urgent PC or Stoller Afferent Nerve Stimulator (SANS) for PTNS. Studies were considered "good quality" if results from objective measures were provided for ≥20 women, results distinguished between type of OAB symptom, and data were reported separately for female subjects. RESULTS: Of the 136 identified articles, 17 met inclusion criteria for data abstraction; 4 of the 17 studies met our criteria for good quality and reported success rates of 54-93 %. Recurrent limitations in the literature were pooling of results for male and female subjects and lack of differentiation in the data on specific symptoms of OAB treated. Short-term follow-up and infrequent use of a control arm were also noted shortcomings of reviewed studies. CONCLUSIONS: Limited high quality data exist on PTNS for OAB in women. Although initial studies have demonstrated promise, more comprehensive evaluation of PTNS is needed to support its universal use for the treatment of OAB in women.

Lead migration after sacral neuromodulation: surgical revision in fascial versus tined anchoring systems.

INTRODUCTION AND HYPOTHESIS: Our objective was to compare risk of surgical revision after sacral neuromodulator lead migration based on the type of anchoring system. METHODS: We performed a retrospective cohort study of patients receiving sacral neuromodulation over 7 years. We compared surgical revision due to loss of efficacy accompanied by radiographic lead migration in fascial-anchored versus tined leads. RESULTS: Of 112 patients, 28 (25%) underwent fascial anchoring, and 84 (75%) received tined leads. Within 2 years of implantation, lead migration occurred in 26% of fascial and 10% of tined anchoring systems (RR, 2.25 (95% confidence interval, 0.85-5.93)). Patients with fascial anchors were followed for a longer period of time. Therefore, Kaplan-Meier curves were compared showing no difference in risk of lead migration (p = 0.09). Four of eight (50%) lead migrations in tined leads occurred within the first 3 months after implantation. CONCLUSIONS: Two years after sacral neuromodulator implantation, lead migration is similar between fascial-anchored and tined leads.

Efficacy and adverse events of sacral nerve stimulation for overactive bladder: A systematic review.

AIMS: To systematically review the literature regarding efficacy and adverse events of sacral nerve stimulation (SNS) via the InterStim device for treatment of women with refractory overactive bladder (OAB). METHODS: We searched MEDLINE, Embase, Web of Science, and the Cochrane Collaboration databases from 1980 to September 2008. All English studies reporting on efficacy or adverse events of SNS for the treatment of refractory OAB were considered. Only studies where 30 or more women received the complete therapy (implanted lead and generator) were included. The quality of the studies (good, fair, or poor) was assessed based on predefined criteria. RESULTS: Seven studies were designated "good" regarding efficacy of SNS for OAB. Multiple authors reported results from the same cohort of patients. In this instance, the highest quality study was chosen, leaving three independent studies regarding efficacy. In these studies, incontinent episodes per day and pad usage significantly improved after SNS therapy. Six studies were designated "good" regarding adverse events. Using tined leads, surgical revision rates ranged from 3% to 16%. Six percent of patients were explanted due to lack of efficacy and 5-11% of patients were explanted due to infection. CONCLUSIONS: Based on observational data, SNS appears effective for treatment of OAB in women. Adverse event rates with tined leads are lower than previously published estimates using non-tined leads. High-quality studies are needed to confirm our findings and to provide additional data regarding reprogramming, quality of life, and efficacy when compared to other therapies.