Sacral neuromodulation and peripheral nerve stimulation in patients with anal incontinence: an overview of techniques, complications and troubleshooting.
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SUBMITTER: Zbar AP
PROVIDER: S-EPMC4020133 | biostudies-literature | 2014 May
REPOSITORIES: biostudies-literature
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Sacral neuromodulation and peripheral nerve stimulation in patients with anal incontinence: an overview of techniques, complications and troubleshooting.
Gastroenterology report 20140410 2
Sacral neuromodulation (SNM) therapy has revolutionized the management of many forms of anal incontinence, with an expanded use and a medium-term efficacy of 75% overall. This review discusses the technique of SNM therapy, along with its complications and troubleshooting and a discussion of the early data pertaining to peripheral posterior tibial nerve stimulation in incontinent patients. Future work needs to define the predictive factors for neurostimulatory success, along with the likely mecha ...[more]
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Project description:BACKGROUND: Some patients with faecal incontinence are not amenable to simple surgical sphincter repair, due to sphincter weakness in the absence of a structural defect. AIMS: To evaluate the efficacy and possible mode of action of short term stimulation of sacral nerves in patients with faecal incontinence and a structurally intact external anal sphincter. PATIENTS: Twelve patients with faecal incontinence for solid or liquid stool at least once per week. METHODS: A stimulating electrode was placed (percutaneously in 10 patients, operatively in two) into the S3 or S4 foramen. The electrode was left in situ for a minimum of one week with chronic stimulation. RESULTS: Evaluable results were obtained in nine patients, with early electrode displacement in the other three. Incontinence ceased in seven of nine patients and improved notably in one; one patient with previous imperforate anus and sacral agenesis had no symptomatic response. Stimulation seemed to enhance maximum squeeze pressure but did not alter resting pressure. The rectum became less sensitive to distension with no change in rectal compliance. Ambulatory studies showed a possible reduction in rectal contractile activity and diminished episodes of spontaneous anal relaxation. CONCLUSIONS: Short term sacral nerve stimulation notably decreases episodes of faecal incontinence. The effect may be mediated via facilitation of striated sphincter muscle function, and via neuromodulation of sacral reflexes which regulate rectal sensitivity and contractility, and anal motility.
| S-EPMC1727421 | biostudies-other
Project description:IntroductionFaecal incontinence (FI) is a common condition with a significant impact on quality of life (QoL). Neuromodulation treatments delivered by members of the multidisciplinary team including sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) are options for FI refractory to conservative management. The aim of this study was to assess whether a successful treatment with one neuromodulation modality corresponds with success in the other.MethodsA retrospective review of a prospectively managed neuromodulation database identified 15 patients who had undergone both PTNS and SNS. The definition of success of each treatment was a >50% improvement in any of The St. Mark's Incontinence Score, Manchester Health Questionnaire, or weekly faecal urgency or FI episodes.ResultsComplete data from 12 patients was available for assessment and PTNS was delivered as the first treatment in nine patients. Overall, seven patients (58%) had successful PTNS treatment, with 10 (83%) having a successful SNS trials. Of the seven patients who had successful PTNS treatment, six patients (85.4%) went on to have success with SNS. Of the five patients who failed PTNS, four (80%) went on to have SNS success. Five (71%) of those who had positive PTNS outcomes had permanent SNS implantation as their final treatment decision.ConclusionThis study suggests that there is no clear relationship between successful PTNS treatment and an SNS trial period which may be explained by differing mechanisms of action or the potential placebo effect of PTNS. Further work is required to investigate any association in larger studies to inform clinical practice.
| S-EPMC10864541 | biostudies-literature
Project description: Not available
| S-EPMC5534324 | biostudies-literature
Project description: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.
| S-EPMC6911169 | biostudies-literature
Project description:Sacral nerve stimulation or sacral neuromodulation involves the implantation of a stimulating electrode lead through the sacral foramina. In patients with anatomical sacral anomalies, it can constitute a challenging procedure due to a lack of common reference points present in the normal anatomy. In this study, we present an innovative application of additive manufacturing for the planning of sacral nerve stimulation techniques and related surgical procedures in complex cases, and we verify that the use of personalized patient models may help to manage the presence of sacral anomalies. The use of two alternative additive manufacturing technologies working with thermoplastic and thermoset polymers, including fused deposition modeling as low-cost alternative and laser stereolithography as industrial gold standard, is compared in terms of viability, precision and overall production costs. They pay special attention to fidelity in terms of the bone microstructure reconstruction, which is necessary for adequately planning electrode insertion. Advantages and limitations of the alternative approaches are discussed and ideas for future developments and for solving current challenges are presented.
| S-EPMC7182873 | biostudies-literature
Project description:ImportanceWomen with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information.ObjectiveTo assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence.Design, setting, and participantsMulticenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence.InterventionsCystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189).Main outcomes and measuresPrimary 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.ResultsOf 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 relevanceAmong 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.
| S-EPMC5399419 | biostudies-literature
Project description:BackgroundSacral neuromodulation (SNM) is a common treatment for patients with urinary and faecal incontinence. A close contact of the tined lead electrode with the targeted nerve is likely to improve functional outcome. The aim of this study was to compare the position of the SNM lead in relation to the sacral nerve by comparing different implantation techniques.MethodsThis cadaver study was conducted at the Division of Anatomy of Vienna's Medical University in October 2020. We dissected 10 cadavers after bilateral SNM lead implantation (n = 20), using two different standardized implantation techniques. The cadavers were categorized as group A (n = 10), representing the conventional guided implantation group and group B (n = 10), where SNM implantation was conducted with the novel fluoroscopy-guided "H"-technique. The primary goal was to assess the distance between the sacral nerve and the lead placement.ResultsThe electrodes were inserted at a median angle of 58.5° (46-65°) in group A and 60° (50-65°) in group B, without reaching statistical significance. In 8 cadavers, the lead entered the S3 foramen successfully. The median distance of the lead to the nerve did not show a significant difference between both groups (E0: Group A: 0.0 mm vs. Group B: 0.0 mm, p = 0.969; E1: Group A: 0.0 mm vs. Group B: 0.5 mm p = 0.754; E2: Group A: 2.5 mm vs. Group B: 2.5 mm p = 1.000; E3: Group A: 3.5 mm vs. Group B: 4.0 mm p = 0.675). In 2 cases (20%) of the conventional group A, the lead was misplaced and located at the gluteal muscle. Perforation of the presacral fascia was observed in one lead placement in group A and in two placements in group B.ConclusionsBoth standardized implantation techniques may ensure close electrode proximity to the targeted nerve. Misplacement of the electrode was more often observed with the conventional implantation technique.
| S-EPMC9360091 | biostudies-literature
Project description: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.
| S-EPMC5433900 | biostudies-literature
Project description:Background/Aims:The aim of this study was to evaluate the sustainability of sacral neuromodulation (SNM) success in patients with fecal incontinence (FI) and/or constipation. Methods:This is a retrospective analysis of a prospective database of patients who received SNM therapy for FI and/or constipation between 2006 and 2015. Success rates, complications and reintervention rates were assessed after up to 10 years of follow-up. Results:Electrodes for test stimulation were implanted in 101 patients, of whom 79 (78.2%) received permanent stimulation. The mean follow-up was 4.4 ± 3.0 years. At the end of follow-up, 57 patients (72.2%) were still receiving SNM. The 5-year success rate for FI and isolated constipation was 88.2% (95% confidence interval [CI], 80.1-97.0%) and 31.2% (95% CI, 10.2-95.5%), respectively (P ? 0.001). In patients with FI, involuntary evacuations per week decreased ? 50% in 76.1% of patients (95% CI, 67.6-86.2%) after 5 years. A lead position at S3 was associated with an improved outcome (P = 0.04). Battery exchange was necessary in 23 patients (29.1%), with a median battery life of 6.2 years. Reinterventions due to complications were necessary in 24 patients (30.4%). For these patients, the 5-year success rate was 89.0% (95% CI, 75.3-100.0%) compared to 78.4% (95% CI, 67.2-91.4%) for patients without reintervention. Conclusions:SNM offers an effective sustainable treatment for FI. For constipation, lasting success of SNM is limited and is thus not recommended. Reinterventions are necessary but do not impede treatment success.
| S-EPMC6326196 | biostudies-literature
Project description: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.
| S-EPMC7204548 | biostudies-literature