Outcome Of Sacral Nerve Stimulation Research Articles

Sacral Nerve Stimulation for Fecal Incontinence Related to External Sphincter Atrophy

Atrophy of the external anal sphincter, a pathologic muscle volume anomaly associated with fecal incontinence, has been shown to be a negative predictor of the outcome of surgery for defects of the external anal sphincter. It is unclear whether external anal sphincter atrophy also affects the outcome of sacral nerve stimulation for fecal incontinence. Our aim was to assess the effectiveness of sacral nerve stimulation in patients with fecal incontinence and external anal sphincter atrophy and to determine whether severity of atrophy and concomitant presence of a sphincter defect are negative predictors of outcome. This was a prospective observational study of treatment outcome. The study was conducted from November 2004 through November 2010 at a regional hospital in Italy. Consecutive patients with fecal incontinence and external anal sphincter atrophy were included. By means of MRI, patients were determined to have either moderate (<50%) or severe (≥ 50%) thinning of and/or replacement of sphincter muscle by fat. The concomitant presence of defects of the external anal sphincter was also detected by MRI. All patients underwent sacral nerve stimulation through a staged implantation procedure. The main outcome measures were improvement in the Cleveland Clinic Florida Fecal Incontinence Scale (Wexner score), number of episodes of incontinence per week, and the Fecal Incontinence Quality of Life Scale. A total of 28 patients underwent definitive implantation of the sacral nerve stimulation device. Wexner scores decreased from a median of 16 (range, 10-20) at baseline to 3 (range, 0-8) at 6-month follow-up (p < 0.001). Weekly incontinence episodes decreased from a mean (SD) of 14.7 (12.5) to 0.40 (0.82); p < 0.001. Improvement was significantly related to severity of fecal incontinence (r = 0.86; p < 0.001). Overall quality-of-life scores improved from a mean of 1.8 (0.6) to 3.8 (0.4);p < 0.001. Sacral nerve stimulation was effective in both moderate (n = 16) and severe (n = 12) atrophy and in patients with (n = 8) or without (n = 20) external anal sphincter defects. The study was limited by its observational nature and relatively small sample size. Sacral nerve stimulation can be effective in restoring continence and improving quality of life in patients with fecal incontinence related to atrophy of the external anal sphincter, regardless of the severity of atrophy. Moreover, the presence of EAS atrophy does not influence the success of the outcome of SNS in patients with a sphincter defect. These findings are consistent with the hypothesis that the effects of SNS are not achieved solely by its action on the anal sphincter complex.

Sacral nerve stimulation in patients with severe fecal incontinence after rectal resection

Oncologic resection of rectal cancer has been reported to be associated with a significant rate of fecal incontinence (FI). The risk is greater in patients with a resection less than 6–8 cm from the anal verge [1]. Sacral nerve stimulation (SNS) has been advocated as a safe and effective therapy for severe FI and shown to be associated with minimal morbidity [2]. In patients with FI after anterior resection (AR), SNS is has been used in few cases, with varying results [1, 3]. Between 2006 and 2009, four patients (one male, three female), with severe FI following neoadjuvant therapy and AR performed for rectal cancer, were treated in our hospital with SNS. The median age was 65.5 years (range 49–73 years). All patients had undergone chemoradiation before the operation. Total mesorectal excision and longitudinal coloplasty had been performed during the operation in all patients. The mean distance of the anastomosis from the anorectal ring was 5 cm (range 2–8 cm). The median history of FI following AR was 26.5 months (range 25–28 months). None presented tumor recurrence, local or distant. The incontinence status was classified according to the Wexner score [4]. All patients were treated with conservative treatment, including drugs, constipating diet and biofeedback physiotherapy for 2 years. Before surgery, in all patients, anorectal manometry and endoanal ultrasonography were performed (Table 1). The percutaneous test stimulation was performed under general anesthesia. The response of S2–S4 was tested on both sides. If contraction of the anal sphincters could be obtained by SNS, percutaneous electrodes (Medtronic 3050; Medtronic, Minneapolis, MN, USA) were implanted. The patients were subsequently tested by SNS for a 4-week period. Patients who became candidates for permanent implantation based on an improvement of their continence received the permanent stimulation generator (INTERSTIM II, 3058; Medtronic, Minneapolis, MN, USA) under general anesthesia. Differences were analyzed by the Wilcoxon test for paired data. All patients tested had contraction of the anal sphincters during the SNS 4-week test period. All patients had least a 50 % reduction in episodes of incontinence and were given a permanently implanted system. The Wexner score fell from a median score of 15.5 before SNS to 5.5 during permanent stimulation (p \ 0.005). There were no significant differences in sphincter pressures measured by anal manometry. The patients with associated urinary incontinence presented improvement in their symptoms. There was no cessation of clinical response during the follow-up, and no complications were observed. After colorectal or coloanal anastomoses at a lower location, about 30–60 % of patients develop anal dysfunction due to the loss of the rectum and internal sphincter. These patients develop clinical symptoms and signs, such as anterior resection syndrome, which includes stool frequency, urgency, fragmentation and soiling. These symptoms usually disappear approximately 1 year postoperatively [5]. Our results of SNS in patients with FI after P. Moya A. Arroyo A. Frangi F. Candela Polo R. Calpena Rico Department of Surgery, University General Hospital of Elche, Alicante, Spain

Long-Term Outcomes of Sacral Nerve Stimulation for Fecal Incontinence

In patients with fecal incontinence who do not benefit from medical or behavioral treatments sacral nerve stimulation is now considered a first-line procedure. Although the efficacy of treatment appears to be sustained in the short and medium term, the long-term results of therapy are relatively unknown. We report the results of chronic sacral nerve stimulation in patients who have had more than 8 years of therapy. All patients who underwent sacral nerve stimulation for fecal incontinence from 1996 to 2002 were followed up prospectively. Data were collected prospectively by the use of bowel habit diaries and St Mark's continence scores. Treatment success was defined as >50% reduction in episodes of fecal incontinence with sacral nerve stimulation in comparison with baseline symptoms. Between January 1996 and December 2002, 25 patients (male/female 2:23; median age, 54 years (range, 35-68 years) underwent temporary sacral nerve stimulation. Twenty-three (92%) patients had a greater than 50% improvement in their ability to defer defecation during the trial phase and were considered suitable for chronic stimulation. Over a median follow-up of 114 months (range, 96-164 months), full continence was maintained in 12 (48%) of the 23 patients who received a neurostimulator implant. Two patients lost efficacy at 48 and 60 months after permanent implant for unknown reasons and had the device removed. Three patients died at 3, 8, and 9 years after permanent implant because of unrelated comorbidities. Nine patients required a change of battery at a mean (SD) of 87 (13.5) months. Sacral nerve stimulation can maintain a persistent clinical benefit in the long term for the majority of patients. Some patients will experience deterioration in their symptoms over time, for reasons yet unknown.

Urethral Instability Appears To Be a Valuable Urodynamic Parameter for Predicting the Outcome of Sacral Nerve Stimulation

Urethral Instability Appears To Be a Valuable Urodynamic Parameter for Predicting the Outcome of Sacral Nerve Stimulation

Long-term Efficacy and Safety of Sacral Nerve Stimulation for Fecal Incontinence

Sacral nerve stimulation is effective in the treatment of urinary incontinence and is currently under Food and Drug Administration review in the United States for fecal incontinence. Previous reports have focused primarily on short-term results of sacral nerve stimulation for fecal incontinence. The present study reports the long-term effectiveness and safety of sacral nerve stimulation for fecal incontinence in a large prospective multicenter study. Patients with fecal incontinent episodes more than twice per week were offered participation in this multicentered prospective trial. Patients showing ≥ 50% improvement during test stimulation were offered chronic implantation of the InterStim Therapy system (Medtronic; Minneapolis, MN). The aims of the current report were to provide 3-year follow-up data on patients from that study who underwent sacral nerve stimulation and were monitored under the rigors of an Food and Drug Administration-approved investigational protocol. One hundred thirty-three patients underwent test stimulation with a 90% success rate, of whom 120 (110 females) with a mean age of 60.5 years and a mean duration of fecal incontinence of 7 years received chronic implantation. Mean length of follow-up was 3.1 (range, 0.2-6.1) years, with 83 patients completing all or part of the 3-year follow-up assessment. At 3 years follow-up, 86% of patients (P < .0001) reported ≥ 50% reduction in the number of incontinent episodes per week compared with baseline and the number of incontinent episodes per week decreased from a mean of 9.4 at baseline to 1.7. Perfect continence was achieved in 40% of subjects. The therapy also improved the fecal incontinence severity index. Sacral nerve stimulation had a positive impact on the quality of life, as evidenced by significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument at 12, 24, and 36 months of follow-up. The most common device- or therapy-related adverse events through the mean 36 months of follow-up included implant site pain (28%), paresthesia (15%), change in the sensation of stimulation (12%), and infection (10%). There were no reported unanticipated adverse device effects associated with sacral nerve stimulation therapy. Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with fecal incontinence. These data support long-term safety and effectiveness to 36 months.

Sacral Nerve Stimulation for Fecal Incontinence: Long-term Outcomes

Numerous studies advocate the short-term benefits of sacral nerve stimulation for fecal incontinence, but there has been a paucity of studies on longer-term outcomes. The objective of this study was to report the long-term outcome of sacral nerve stimulation performed for fecal incontinence at a single institution. Between January 2004 and May 2007, 53 patients underwent definitive sacral nerve stimulation for fecal incontinence at our institution. Prospectively recorded baseline information, including Wexner incontinence scores and standard short-form (SF-12) health survey scores, were compared with scores at follow-up. Forty-one patients were available for long-term follow-up with a mean duration of 51 months. The median Wexner score decreased from a baseline of 11.5 (range, 3.0-18.0) to 8.0 (range, 0.0-18.0) at follow-up. The mean difference in Wexner score was 2.7 (P < .001). There was no statistically significant change in SF-12 physical scores, but a small but highly significant change occurred in SF-12 mental scores. The median SF-12 mental domain score was 49.5 (range, 15.0-62.1) at baseline, and 57.0 (range, 20.0-64.0) at follow-up, with a mean difference of 4.5 (P = .006). Subgroup analysis performed comparing patients with or without prior intersphincteric silicon biomaterial implants demonstrated a mean difference in Wexner score of -3.5 (no implant) vs 0.0 (previous implant), with P < .09 (not statistically significant). Sacral nerve stimulation results in a statistically significant improvement in fecal incontinence scores in the long term.

Sacral nerve stimulation for faecal incontinence: patient selection, service provision and operative technique

Faecal incontinence is estimated to affect between 2 and 3% of Western adult populations. In recent years sacral nerve stimulation has become an important treatment modality, often as the first-line surgical therapy. The aim of this article was to review the current evidence regarding patient selection and surgical technique and to evaluate the logistics of providing a neurostimulation service. A Medline search was performed including the keywords and/or MeSH headings of sacral nerve stimulation, neuromodulation, artificial pacemaker, faecal incontinence, patient selection, predictive factors and anal canal. Further studies were identified by cross-referencing from relevant articles and by appraisal of recent peer-reviewed conference abstracts and proceedings. Despite the success of sacral nerve stimulation for several pathophysiological causes of incontinence, case selection is of paramount importance. Sacral nerve stimulation should not be offered outside a multidisciplinary pelvic floor unit. Temporary evaluation using diary cards can lead to false positive and negative results. Adherence to a meticulous surgical technique, using low amplitude stimulation to guide lead placement, provides optimal clinical outcome. The short-term outcome of sacral nerve stimulation is dependent on patient factors and operative technique. Despite this, specific preoperative predictive factors of treatment success have yet to be identified.

Update on the treatment of overactive bladder

As overactive bladder (OAB) is a prevalent and chronic medical condition that greatly impacts an individual's quality of life, novel therapeutic options are always welcome. Recent evidence suggests that newer antimuscarinic agents are not only superior to placebo, but may also have a role in treating OAB symptoms in children and men with lower urinary tract symptom. Dose escalation for trospium and fesoterodine has shown to be both efficacious and safe. Adverse events typically exceed those of placebo but infrequently lead to cessation of therapy. Long-term outcomes of sacral nerve stimulation for refractory OAB have been recently reported. Although the overall satisfaction with this therapy is high, more than 50% may experience chronic pain; however, this adverse event also does not frequently lead to device removal. Percutaneous tibial nerve stimulation continues to display superiority to sham treatment and benefits similar to antimuscarinic therapy may be observed. This therapy is well tolerated and durable outcomes have been seen at 12 months of follow-up. Recent evidence suggests that a dose of 100 U per botulinum neurotoxin type A injection may optimally balance symptom improvement and incidence of voiding difficulty. Treatment modalities for OAB continue to evolve and the abundance of options can only benefit the individuals with this condition.

Long term outcomes of sacral nerve stimulation for faecal incontinence

IntroductionIn patients with faecal incontinence (FI) who fail to benefit from medical or behavioural treatments sacral nerve stimulation (SNS) is now considered a first-line procedure.1 While the efficacy of treatment...

Sacral nerve stimulation in the elderly

Sacral neuromodulation has become a widely accepted form of therapy in the overall spectrum of treatment options for urinary urgency and frequency, urge urinary incontinence, and some forms of nonobstructive urinary retention. Voiding dysfunction is very common in geriatric patients, and urgency and urge urinary incontinence are among the most prevalent forms of urinary problems in this population. Despite the fact that many different treatment options are available for these conditions, successful treatment of voiding problems in the elderly is often quite challenging. This may be exacerbated by underlying comorbidities which preclude or limit the utility of some therapies including medications. Published literature on the use and clinical outcomes of sacral nerve stimulation in older adults was reviewed and summarized. Available clinical studies examining the use of sacral neuromodulation in geriatric patients are reviewed and placed in the context of the overall treatment of voiding dysfunction in the elderly population. Sacral neuromodulation may represent a viable, minimally invasive treatment option for some older adults.

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Sacral Nerve Stimulation for Refractory Overactive Bladder in the Elderly Population

We determined the long-term outcome of sacral nerve stimulation for refractory overactive bladder in the elderly population. We performed a prospective longitudinal study to better characterize the outcome of sacral nerve stimulation in female patients 70 years old or older with refractory overactive bladder. Demographic and perioperative data were recorded. Patients were followed postoperatively for evidence of successful stage conversion, device durability and efficacy, and postoperative complications. Patients were retrospectively compared to a cohort of female patients younger than 70 years with refractory overactive bladder. Statistical analysis was performed. Between July 2001 and February 2008, 19 elderly female patients with refractory overactive bladder underwent stage 1 lead placement. Of the patients 17 (90%) who reported greater than 50% improvement in symptoms based on a 1-week followup voiding log underwent implantable pulse generator placement. No intraoperative or immediate postoperative complications were noted. At a mean followup of 48.5 months 11 patients (65%) had a functional implantable pulse generator with greater than 50% objective improvement over baseline. Compared to matched patients younger than 70 years elderly patients had a similar conversion rate and adverse events but were significantly more likely to undergo device removal (p = 0.018). Based on our experience elderly patients have a high conversion rate, few adverse events, and a high level of device efficacy and durability with sacral nerve stimulation. Although more mature multicenter data are needed, it appears that sacral nerve stimulation in geriatric patients is safe and efficacious, and should be judiciously offered to those with refractory voiding symptoms.

Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence

Sacral nerve stimulation is a safe and effective procedure for fecal incontinence. We investigated whether its efficacy is maintained long term. Sixty patients with fecal incontinence underwent permanent sacral nerve stimulation. Patients' data were prospectively recorded in the national registry of the Italian Group of sacral nerve stimulation. The severity of fecal incontinence was evaluated by the Wexner score, and data were collected in a bowel function diary. Quality of life was evaluated by the Italian version of the Medical Outcomes Survey Short Form (SF-36) questionnaire. Fifty-two patients were available for long-term follow-up lasting at least 5 years. Compared with baseline, the Wexner score decreased significantly after definitive implantation (from 15 +/- 4 to 5 +/- 5, P < 0.001). At least 50 percent improvement in continence was achieved in 74 percent of the patients, and at least 70 percent improvement (median value) was achieved in 50 percent. The mean number of solid/liquid incontinence episodes decreased significantly from 0.5 (+/-0.5) to 0.1 (+/-0.3) per day (P = 0.004). Quality of life improved in all domains. The overall mean improvement in SF-36 scores was 39.8 percent. Both mean resting and squeeze anal pressures increased significantly, and maximum volume tolerated decreased significantly. Sacral nerve stimulation maintains its efficacy long term, not only in regard to control of symptoms but also regarding quality of life.

Urethral Instability and Sacral Nerve Stimulation—A Better Parameter to Predict Efficacy?

Urodynamic parameters that predict the outcome of sacral nerve stimulation are difficult to define. We studied the predictive value of urethral instability and other urodynamic parameters on the efficacy of sacral nerve stimulation. Patients with refractory voiding disorders were implanted with a neurostimulator after responding with more than 50% improvement in main symptoms after percutaneous nerve evaluation. Filling cystometry was performed with 3 urethral sensors and 1 bladder sensor at baseline and 6 months after implantation. Urethral pressure variations more than 15 cm H(2)O were considered pathological and defined as urethral instability. Clinical efficacy was evaluated by voiding diary data and defined as successful when greater than 50% improvement was observed. A total of 19 female patients enrolled in the study. At baseline detrusor overactivity was observed in 9 patients, while 18 showed urethral instability. Sacral nerve stimulation therapy was successful in 13 patients (68%). The number of pads used per day and the severity of leakage decreased significantly. Of the 13 successfully treated patients 12 showed urethral instability at baseline. Detrusor overactivity was present in 4 successfully treated patients. Urethral instability disappeared in 7 of the 13 successfully treated patients and detrusor overactivity disappeared in only 1 of these patients. In this study urethral instability appeared to be a valuable urodynamic parameter for predicting the outcome of sacral nerve stimulation.

The Presence of Fowler’s Syndrome Predicts Successful Long-Term Outcome of Sacral Nerve Stimulation in Women with Urinary Retention

ObjectivesSacral nerve stimulation (SNS) is an effective treatment for women with urinary retention. Some women present specific electromyography abnormalities of the external urethral sphincter (Fowler’s syndrome). The aim of this study was to evaluate whether Fowler’s syndrome and psychologic preimplant screening could be predictive factors for long-term success of SNS in women with urinary retention. MethodsAll patients underwent electrophysiologic and urodynamic studies and voiding charts. A validated psychologic screening questionnaire was used. Women with successful temporary stimulation, received a definitive implant (Interstim Medtronic). They were followed prospectively every 6 months. Failure was defined as recurrent retention needing intermittent or permanent catheterisation. ResultsSixty-two women were implanted, 30 with Fowler’s syndrome, 32 with idiopathic retention. In those with Fowler’s syndrome, 26.6% screened positive for somatisation, as did 43.8% in the idiopathic group (not significant [ns]). Screening for depression was positive in 30% and 18.8%, respectively (ns). There was no correlation with outcome. Twenty-eight patients failed: 9 with Fowler’s syndromes, 19 without (p=0.04). Kaplan-Meier analysis showed that patients with Fowler’s syndrome benefitted significantly longer from SNS (log-rank test, p=0.005). ConclusionsThe presence of Fowler’s syndrome is a positive predictive factor for SNS in female urinary retention. Idiopathic urinary retention patients can benefit as well, but the success might be less predictable. Preimplant psychologic screening, using the Patient Health Questionnaire, does not correlate with long-term outcome of SNS in this population.

Sacral Neuromodulation in Women With Idiopathic Detrusor Overactivity Incontinence: Decreased Overactivity but Unchanged Bladder Contraction Strength and Urethral Resistance During Voiding

We evaluated the effect of sacral (S3) nerve neuromodulation on voiding in women with idiopathic detrusor overactivity incontinence. Urodynamic measurements in all patients implanted in 1990 to 2003 were reconsidered. Patients were included if these measurements, which were done at baseline and after 6 months, could be analyzed completely and reliably. Maximum detrusor pressure, amplitude of the highest involuntary detrusor contraction and end fill volume were used as parameters characterizing the degree of detrusor overactivity. Urethral resistance and bladder contraction strength during voiding were characterized by the bladder outlet obstruction index, the urethral resistance factor, average pressure, the slope of the low pressure side of the pressure flow plot, the bladder contractility index and the bladder contraction strength parameter. A total of 33 women were included. Detrusor overactivity parameters were significantly improved at followup. In addition, the supine position of the patient during filling in followup measurements proved less provocative with respect to overactivity than the standing position in the majority of measurements at baseline. Consequently bladder volumes at which voiding was initiated were considerably higher at followup. Changes in the parameters characterizing urethral resistance and bladder contraction strength during voiding were not unambiguous. However, exactly those parameters that appeared volume independent in a previous study were not significantly different. Our study confirmed the depressant effect of sacral (S3) nerve neuromodulation on detrusor overactivity. No effect on urethral resistance and bladder contraction strength during voiding could be demonstrated using volume independent parameters.

Long-term results of sacral neuromodulation for women with urinary retention.

OBJECTIVE ; To review the long-term results of sacral nerve stimulation in the treatment of women with Fowler's syndrome, over a 6-year period at one tertiary referral centre. Between 1996 and 2002, 26 women with urinary retention were treated by implanting a sacral nerve stimulator. Their case records were reviewed for follow-up, complications and revision procedures, and the most recent uroflowmetry results. There were 20 patients (77%) still voiding spontaneously at the time of review (with two having deactivated their stimulator because of pregnancy). Fourteen patients (54%) required revision surgery, and the most common complications included loss of efficacy, implant-related discomfort and leg pain. The mean postvoid residual volume was 75 mL and mean maximum flow rate 20.8 mL/s. In young women with retention, for whom there is still no alternative to lifelong self-catheterization, sacral neuromodulation is effective for up to 5 years after implantation. However, there was a significant complication rate, in line with other reports, which may be improved by new technical developments.

QUALITY OF LIFE ASSESSMENT IN PATIENTS WHO UNDERGO SACRAL NEUROMODULATION IMPLANTATION FOR URGE INCONTINENCE: AN ADDITIONAL TOOL FOR EVALUATING OUTCOME

We investigated the impact of sacral neuromodulation on quality of life and assessed the importance of quality of life for determining the success of sacral neuromodulation in patients with detrusor hyperactivity, including instability and hyperreflexia. We also compared it with parameters documented in a voiding diary. From May 1998 to December 2000, 82 female and 31 male patients 17 to 79 years old (mean age 51.1) with urge incontinence (63), urgency/frequency (5), voiding disturbance (41) and pelvic pain (4) resistant to conservative treatment were enrolled in a national prospective registry after showing a positive response to percutaneous nerve evaluation testing. Of the patients 47 who were 32 to 79 years old (mean age 59.2) with urge incontinence due to detrusor instability and 16 who were 27 to 51 years old (mean age 51.5) with hyperreflexia were asked to complete a validated self-reporting incontinence domain specific quality of life questionnaire before, and 3, 6, 9, 12, 18, 24 and 36 months after implantation. Compared with baseline the quality of life index significantly improved at each followup, which strongly correlated with the decrease in the number of incontinence episodes. Evaluating quality of life may be an additional useful tool for assessing the results of sacral neuromodulation for urge incontinence. Our study confirms that sacral neuromodulation is effective therapy for urge incontinence that can have a positive effect on patient quality of life.