The effect of the number of active electrode poles during tined lead placement on long-term efficacy of sacral neuromodulation in patients with faecal incontinence.

AIM: There is an ongoing debate as to whether or not the efficacy of sacral neuromodulation (SNM) is optimized by maximizing the total number of active electrode poles (AEPs) during lead placement because there are more programming options. However, this is at the cost of increased operating time. The aims of this study were to establish if a higher number of AEPs improves SNM efficacy during the trial period and after permanent implantable pulse generator (IPG) placement and if there is there a correlation between number of AEPs and battery life of the first placed IPG. METHOD: This was a single centre retrospective cohort study of new patients with faecal incontinence who underwent SNM between 2000 and 2018. Exclusion criteria were sphincter defect > 30%, rectocele/enterocele Grade 3 or higher and incomplete records. RESULTS: In all, 288/456 (63%) patients (women 91%; mean age 58.5 ± 11.7 years) were eligible for analysis. The number of AEPs during lead placement was two (n = 42, 14.5%), three (n = 82, 28.5%) and four (n = 164, 57%). There was no association between the number of AEPs during tined lead placement and long-term efficacy. Neither the success rate of the trial phase nor the battery life after first placed IPG was influenced by the number of AEPs. CONCLUSION: In this study, the number of AEPs does not seem to influence long-term efficacy of SNM success rate during the trial phase or the battery life of the first placed IPG. However, we also suggest that at the very least there should be two AEPs at lead placement.

Long-term outcomes of a Malone antegrade continence enema (MACE) for the treatment of fecal incontinence or constipation in adults.

PURPOSE: The aim of the study was to assess the long-term outcome of a Malone antegrade continence enema (MACE) procedure for fecal incontinence or constipation in adults. METHODS: This retrospective single-center study assessed the long-term outcome and quality of life (QoL) of patients who underwent a MACE procedure between 2005 and 2014 at the Maastricht University Medical Centre. Success rate was quantified by using Malone's continence scale. Quality of life was assessed by validated questionnaires covering general quality of life (SF-36 and Karnofsky scale), current pain level (visual analog scale), fecal incontinence (Vaizey incontinence survey), or constipation (Cleveland Clinic Constipation Score). RESULTS: Based on patients' records, 22 out of 30 patients (73%; 95% CI 54-87%) were still using their MACE. Mean follow-up was 43 months (SD 25.9) since time of surgery. According to the Malone continence scale, the overall success rate was 37% (95% CI 20.0-53.3). Nine patients developed a postoperative complication. Eighteen out of 22 patients (13 with constipation and 5 with fecal incontinence) returned the QoL questionnaires (82% response rate). Long-term quality of life of patients with a MACE did not differ from the general Dutch population. CONCLUSIONS: In our cohort of patients with fecal incontinence or constipation, MACE resulted in a disappointed overall success rate of 37%. However, it may be indicated in patients who do not prefer more invasive surgical procedures or a definite stoma. The success and morbidity rate should be thoroughly discussed with the patients preoperatively.

Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis.

PURPOSE: The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. METHODS: This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, ß = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic. CONCLUSIONS: The results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov , identifier NCT02961582, on 12 October 2016.

Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults.

AIM: Sacral neuromodulation (SNM) is a minimally invasive therapy for functional constipation (FC) and is most often used to treat adults. Recent studies suggest that SNM may also beneficial in children. However, comparative data regarding preferred age of SNM for FC are lacking. Therefore, long-term results of SNM for FC were compared between children and adults. METHOD: All patients treated with SNM for FC between 2004 and 2015 were evaluated. Outcomes of children (age 10-18 years) were compared with those for adults (≥ 18 years). The primary end-point was a defaecation frequency of three or more times per week, which is consistent with the ROME-III criteria. Secondary outcomes were quality of life (QoL; SF-36) and the Cleveland Clinic Constipation Score. RESULTS: One hundred and eighty patients (45 children, 135 adults) were eligible for SNM. The mean age was 15.8 (children) and 41.4 years (adults). One hundred and twenty-six patients received permanent SNM (38 children, 88 adults). Mean follow-up was 47 months in both groups. Defaecation frequency increased in both groups after SNM compared with baseline. Defaecation frequency in adults was higher than in children. The increased defaecation frequency was maintained during the entire follow-up period in both groups. QoL of children was impaired compared with the Dutch population with regard to bodily pain, general health and vitality. Adults had worse QoL with regard to physical functioning, bodily pain, general health, vitality and social functioning compared with the Dutch population. QoL of children did not differ from adults. CONCLUSION: Sacral neuromodulation (SNM) should be considered in children (< 18 years) with FC. However, the indication of SNM for FC remains debatable considering the limited improvements and high costs.

Cost-effectiveness of sacral neuromodulation for chronic refractory constipation in children and adolescents: a Markov model analysis.

AIM: This study aimed to assess the cost-effectiveness of sacral neuromodulation (SNM) compared with conservative treatment in children and adolescents with constipation refractory to conservative management. METHOD: A Markov probabilistic model was used, comparing costs and effectiveness of SNM and conservative treatment in children and adolescents aged 10-18 years with constipation refractory to conservative management. Input for the model regarding transition probabilities, utilities and healthcare costs was based on data from a cohort of patients treated in our centre. This cohort consisted of 30 female patients (mean age 16 years) with functional constipation refractory to conservative management. The mean duration of laxative use in this group was 5.9 years. All patients had a test SNM, followed by a permanent SNM in 27/30. Median follow-up was 22.1 months (range 12.2-36.8). The model was run to simulate a follow-up period of 3 years. RESULTS: The mean cumulative costs for the SNM group and the conservative treatment group were €17 789 (SD €2492) and €7574 (SD €4332) per patient, respectively. The mean quality adjusted life years (QALYs) in the SNM group was 1.74 (SD 0.19), compared with 0.86 (SD 0.14) in the conservatively managed group. The mean incremental cost-effectiveness ratio was €12 328 per QALY (SD €4788). Sensitivity analysis showed that the outcomes were robust to a wide range of model assumptions. CONCLUSION: Chronic constipation seriously affects the quality of life of children and adolescents. Preliminary evidence suggests that SNM can improve symptoms and quality of life at a reasonable cost.

Sacral nerve modulation for defaecation and micturition disorders in patients with spina bifida.

AIM: Sacral nerve modulation is a well accepted method for the treatment of defaecation disorders and voiding dysfunction. Results of sacral nerve modulation in patients with spinal cord lesions are not well assessed, but preliminary results look poor. Therefore, the purpose of this study was to assess the effectiveness of sacral nerve modulation for defaecation disorders and voiding dysfunction in patients with spina bifida. METHOD: Consecutive patients with spina bifida suffering from a myelomeningocele and combined faecal and urinary functional disorders that were eligible for peripheral nerve evaluation (PNE) were studied. A permanent sacral nerve modulation implantation was performed after successful PNE. RESULTS: Ten patients (four female) were included in this study with a median age of 26.4 (range 11.1-41.0) years. In two the PNE was not possible. The median faecal incontinence days (6.0 vs 3.5) and episodes (8.5 vs 3.5) per 21 days decreased significantly during the 3-week period of PNE (P = 0.033). Only 3/10 (30%) patients had a more than 50% improvement and proceeded to a permanent sacral nerve modulation implantation. In one patient it was not possible to perform the permanent implant. CONCLUSION: Preliminary results of sacral nerve modulation in a subgroup of spina bifida patients with combined faecal and urinary functional disorders look promising, but long-term results in larger patient groups need to be studied.

Sacral neuromodulation: long-term outcome and quality of life in patients with faecal incontinence.

AIM: Since 1994 sacral neuromodulation (SNM) has increasingly been used for the treatment of faecal incontinence, but no long-term data in a large group of patients have so far been published. We report long-term outcome and quality of life in the first 50 patients treated by permanent SNM for faecal incontinence. METHOD: We began to use SNM in 2000. Data from the first 50 patients with faecal incontinence who underwent permanent SNM are presented. Efficacy was assessed using a bowel diary and the Quality of Life score was assessed by the Faecal Incontinence Quality of Life questionnaire (FIQOL) and the standard short form health survey questionnaire (SF-36). RESULTS: Over a median follow up of 7.1 (5.6-8.7) years, forty-two (84%) patients had an improvement in continence of over 50%. Median incontinent episodes and days of incontinence per week decreased significantly during follow up (P<0.002). Improvement was seen in all four categories of the FIQOL scale and in some domains of the SF-36 QOL questionnaire. There were no statistically significant changes in the median resting and squeeze anal canal pressures. CONCLUSION: Initial improvement in continence with SNM was sustained in the majority of patients, with an overall success rate of 80% after a permanent implant at 7 years.

The effect of sacral nerve stimulation on uterine activity: a pilot study.

INTRODUCTION: Sacral nerve stimulation (SNS) is a treatment for consecutive therapy resistant faecal incontinence or constipation. Little is known about the effects of SNS on uterocervical function. Therefore, it is advised to turn off the stimulator during pregnancy or to wait with permanent implantation of the stimulator until family completion. Diagnostic ultrasound provides an, non-invasive, opportunity to study various aspects of uterine activity. The purpose of this pilot study was to assess the influence of SNS on endometrial waves of the nonpregnant uterus by ultrasound recordings. METHOD: Six patients with an implanted SNS were included. Ultrasound recordings were performed with the stimulator turned off and in three stimulation frequencies. Uterine activity is described as wave frequency and wave direction. RESULTS: All three premenopausal patients showed endometrial activity with the stimulator turned off. This activity was maintained with the stimulator turned on in two patients, but disappeared in one patient. All three postmenopausal patients had no endometrial activity with the stimulator turned off. In one patient there was activity with the stimulator turned on at a frequency of 21 Hz. CONCLUSION: We have shown some effect of SNS on uterine activity. In premenopausal women we discovered that SNS seems to exhibit no effect or an inhibitory effect rather than an excitatory effect on uterine activity. Based on the preliminary results of this study, we can not recommend any guidelines for SNS usage during conception and pregnancy. A larger study in premenopausal women with SNS is needed to investigate the significance of these changes.

Sacral nerve modulation and other treatments in patients with faecal incontinence after unsuccessful pelvic floor rehabilitation: a prospective study.

OBJECTIVES: Sacral nerve modulation (SNM) is a minimally invasive technique for the treatment of faecal incontinence. This study investigates the results of SNM after negative outcome of a standardized pelvic floor rehabilitation (PFR) programme for the treatment of faecal incontinence. METHOD: A prospective cohort study was performed between December 2001 and August 2007. Consecutive patients who visited the outpatient department for faecal incontinence were included in a multicentre study and treated with standardized PFR. Those with an unsuccessful result who were eligible for SNM were included in the present study. Failures at test stimulation or SNM received another treatment. Clinical outcome, Vaizey scores and Hirschsprung's disease/anorectal malformation quality-of-life (EQ-5D and HAQL) were assessed during follow-up in patients with SNM and in patients with other treatments (OT). Adverse events (AE) were documented. RESULTS: Thirty-five patients (mean age 59.7 years; 31 females) were included. Twenty-one had a successful test stimulation and 19 patients proceeded to a SNM implant. Incontinence episodes per week decreased significantly from 11.1 +/- 11.7 to 1.9 +/- 2.6 during test stimulation (P < 0.0001) and SNM over 24.1 months follow-up. The overall success rate was 49% (17/35). The patients with unsuccessful test stimulation or SNM received OT. The Vaizey score improved in both SNM (18.2 +/- 3.5 vs 13.7 +/- 4.8; P = 0.004) and other treatment (18.2 +/- 3.5 vs 13.9 +/- 6.9; P = 0.019). The HAQL scale improved significantly during SNM in all subscales (P < 0.005), but not in the other treatment group. Eight AE occurred during test stimulation (23%) and six AE after permanent implantation (26%). CONCLUSION: Sacral nerve modulation improves disease specific quality of life significantly compared with other treatment.

Factors associated with percutaneous nerve evaluation and permanent sacral nerve modulation outcome in patients with fecal incontinence.

PURPOSE: Sacral nerve modulation is an established treatment for fecal incontinence. Little is known about predictive factors for successful percutaneous nerve evaluation (or test stimulation) and permanent sacral nerve modulation outcome. The purpose of this retrospective study was to discover predictive factors associated with temporary and permanent stimulation. METHODS: We analyzed data from test stimulations performed in patients with fecal incontinence from March 2000 until May 2007. Successful outcome was defined as >50% improvement of incontinence episodes in three weeks. Patients with a successful test stimulation were eligible for permanent sacral nerve modulation implantation. All patients who subsequently had permanent sacral nerve modulation were analyzed. Logistic regression was used to determine the predictive power of baseline demographics and diagnostic variables. RESULTS: Test stimulations were performed in 245 patients (226 females; mean age, 56.6 (standard deviation, 12.8) years). Our analysis showed that older age (P = 0.014), external anal sphincter defects (P = 0.005), and repeated procedures after initial failure (P = 0.001) were significantly related to failure. One hundred seventy-three patients (70.6%) were eligible for permanent sacral nerve modulation implantation. The analysis showed no significant predictive factors related to permanent sacral nerve modulation. CONCLUSION: Three predictive factors were negatively associated with the outcome of test stimulation: older age, repeated procedures, and a defect in the external anal sphincter. These factors may indicate lower chances of success for test stimulation but do not exclude patients from sacral nerve modulation treatment. Although assessed in a selected patient group, no factors were predictive of the outcome of permanent stimulation.

Can sensory and/or motor reactions during percutaneous nerve evaluation predict outcome of sacral nerve modulation?

PURPOSE: A major advantage of sacral nerve modulation in the treatment of fecal incontinence is the ability to determine the likely treatment outcome before implantation by means of a percutaneous nerve evaluation and a test stimulation period. This study evaluated the predictive value of both sensory and motor responses during percutaneous nerve evaluation for determining the outcome of subchronic test stimulation and permanent stimulation. METHODS: All percutaneous nerve evaluation procedures performed between 2000 and 2007 were analyzed. Two hundred eight procedures (194 females; mean age, 56.7 years) were included in this study. Correct needle placement was confirmed by typical S-3 sensory and/or motor responses. The sensory and motor responses during the procedure were analyzed in relation to the outcomes of the test stimulation and permanent stimulation. RESULTS: In all, 72.6% of patients had a successful subchronic test stimulation. A total of 13.9% had no motor response. There was no significant difference in outcome between the group with only sensory responses and the group with both sensory and motor responses (P = 0.89; odds ratio, 1.01; 95% confidence interval, 0.42-2.43). Correlation with permanent implantation showed no significant difference between both groups in outcome (P = 0.53; odds ratio, 0.48; 95% confidence interval, 0.17-1.41). CONCLUSION: Positive motor responses during percutaneous nerve evaluation are highly predictive of a successful outcome of subchronic test stimulation and permanent sacral nerve modulation. Sensory responses also have the same predictive value. For this reason, percutaneous nerve evaluation preferably should be performed in awake patients under local anesthesia to avoid missing those who may benefit from permanent stimulation but who do not have a motor response during the procedure.

Is a morphologically intact anal sphincter necessary for success with sacral nerve modulation in patients with faecal incontinence?

OBJECTIVE: Sacral nerve modulation (SNM) for the treatment of faecal incontinence was originally performed in patients with an intact anal sphincter or after repair of a sphincter defect. There is evidence that SNM can be performed in patients with faecal incontinence and an anal sphincter defect. METHOD: Two groups of patients were analysed retrospectively to determine whether SNM is as effective in patients with faecal incontinence associated with an anal sphincter defect as in those with a morphologically intact anal sphincter following anal repair (AR). Patients in group A had had an AR resulting in an intact anal sphincter ring. Group B included patients with a sphincter defect which was not primarily repaired. Both groups underwent SNM. All patients had undergone a test stimulation percutaneous nerve evaluation (PNE) followed by a subchronic test over 3 weeks. If the PNE was successful, a permanent SNM electrode was implanted. Follow-up visits for the successfully permanent implanted patients were scheduled at 1, 3, 6 and 12 months and annually thereafter. RESULTS: Group A consisted of 20 (19 women) patients. Eighteen (90%) had a positive subchronic test stimulation. Twelve patients had a successful SNM implant during middle-term follow-up. Group B consisted of 20 women. The size of the defect in the anal sphincter varied between 17% and 33% of the anal circumference. Fourteen (70%) had a positive subchronic test stimulation. Twelve patients had a successful SNM implant during middle-term follow-up. In both groups, the mean number of incontinence episodes decreased significantly with SNM (test vs baseline: P = 0.0001, P = 0.0002). There was no significant difference in resting and squeeze pressures during SNM in group A, but in group B squeeze pressure had increased significantly at 24 months. Comparison of patient characteristics and outcome between groups A and B revealed no statistical differences. CONCLUSION: A morphologically intact anal sphincter is not a prerequisite for success in the treatment of faecal incontinence with SNM. An anal sphincter defect of <33% of the circumference can be effectively treated primarily with SNM without repair.