Outcome Of Sacral Nerve Stimulation Research Articles

Sacral nerve stimulation leads to long-term improvement in fecal incontinence and quality of life for children with functional and organic defecation disorders.

Our objective was to evaluate long-term outcomes of sacral nerve stimulation (SNS) for children with functional and organic defecation disorders. We performed a prospective study of children <21 years of age who started SNS treatment between 2012 and 2018. We recorded demographics, medical history, and diagnostic testing. We obtained measures of symptom severity and quality of life at baseline and follow up at 1, 6, 12, 24, 36, 48, and ≥60 months. Successful response was defined as bowel movements >2 times/week and fecal incontinence (FI) <1 time/week. Families were contacted to administer the Glasgow Children's Benefit Inventory and to evaluate patient satisfaction. We included 65 patients (59% female, median age at SNS 14 years, range 9-21) with median follow-up of 32 months. Thirty patients had functional constipation (FC), 15 had non-retentive FI (NRFI), and 16 had an anorectal malformation (ARM). The percentage with FI <1 time/week improved from 30% at baseline to 64% at 1 year (p < 0.001) and 77% at most recent follow-up (p < 0.001). Patients with FC, NRFI, and ARM had sustained improvement in FI (p = 0.02, p < 0.001, p = 0.02). Patients also reported fewer hard stools (p = 0.001). Bowel movement frequency did not improve after SNS. At most recent follow-up, 77% of patients with a functional disorder and 50% with an organic disorder had responded (p = 0.03). Nearly all families reported benefit. SNS led to sustained improvement in FI regardless of underlying etiology, but children with functional disorders were more likely to respond than those with organic disorders.

1130 Clinical Outcomes of Sacral Nerve Stimulation for Neuromodulation of the Lower Urinary Tract in a Tertiary Hospital

1130 Clinical Outcomes of Sacral Nerve Stimulation for Neuromodulation of the Lower Urinary Tract in a Tertiary Hospital

Long-term Outcomes of Sacral Nerve Stimulation in Pelvic Floor Dysfunctions.

PurposeThe aim of this study was to analyze the long-term outcomes of sacral nerve stimulation (SNS) in both idiopathic and neurogenic pelvic floor disorders in patients treated at a referral center.MethodsThis retrospective observational study analyzed the records of 106 patients tested at our department from December 1999 to January 2017. The efficacy variables evaluated were the Global Response Assessment (range, 0%–100%) and, according to the clinical indication, other specific variables such International Consultation on Incontinence QuestionnaireShort Form, number of catheterizations or pads/day, and the numerical pain scale. The safety variables analyzed were complications (pain, migration, infection), reinterventions and explants. Patients’ quality of life (QoL) and satisfaction with the procedure were evaluated through telephone interviews.ResultsThe clinical indications were overactive bladder (OAB) (n=36), urinary retention (UR) (n=37), bladder pain syndrome/interstitial cystitis (BPS/IC) (n=19), fecal incontinence (FI) (n=8), and double incontinence (DI) (n=6). The implant rates according to the clinical indication were as follows: OAB, 55.6%; UR, 56.8%; BPS/IC, 63.15%; FI, 87.5%; and DI, 66.7%. Clinical and/or statistically significant improvements in all efficacy variables were observed. Loss of therapeutic effect at 75 months of follow-up was observed in 34% of patients. Device-related pain appeared in 25 patients (39%); in 20 patients, it was resolved by reprogramming and 5 patients required device removal. An overall improvement in QoL and high levels of satisfaction with the procedure were observed. More than 90% of patients would recommend SNS to a friend or relative.ConclusionsSNS is a minimally invasive procedure that offers a real alternative to patients with refractory pelvic floor dysfunction. Its safety profile is very favorable and it provides a long-lasting improvement in symptoms and QoL.

Sacral nerve stimulation for the treatment of severe fecal incontinence: long-term quality of life and functional outcomes

The aim is to determine whether good functional and quality of life results of sacral nerve stimulation (SNS) in patients with severe fecal incontinence are maintained in the long-term. Consecutive cohort of patients with severe fecal incontinence not responding to conservative (drugs and/or biofeedback) or surgical (sphincteroplasty) treatment, undergoing SNS between 2002 and 2013. Patients with a definitive implant were individually assessed in consultation throughout the follow-up, until January 2016. Defeca-tory function was assessed by Wexner score and stool diary, and perceived quality of life by FIQL and EQ-5D question-naires. Acute percutaneous nerve evaluation (PNE) was performed on 93 patients; a temporary electrode was implanted in 91 (79.1% women, mean age 62.5 years), obtaining a good functional response in 64. A permanent implant was per-formed in 61 patients, with a mean follow-up of 78.1 months (SD: 35.4; range 1-161); at the end of the study 42 patients remained in follow-up. A significant decrease was observed in the number of days per week with an incontinent episode, from 4.98 (SD 2.1) to 1.25 (SD 1.7), and in Wexner score from 16.88 (SD 2.74) to 6.95 (SD 3.54). Specific FIQL and generic EQ-5D questionnaires showed a significant improvement in quality of life. Long-term functional and quality of life outcomes of SNS for the treatment of severe faecal incontinence is maintained, with individual follow-ups that reach 10 years.

Long-term outcome of sacral nerve stimulation for faecal incontinence.

Sacral nerve stimulation (SNS) is a minimally invasive treatment for faecal incontinence (FI). We report our experience of patients who have undergone SNS for FI with a minimum of 5 years' follow-up. This is a single centre prospective observational study with the aim to assess the long-term function of SNS. All patients implanted with SNS were identified from our prospective database. The date of implantation, first and last clinic follow-up, surgical complications and St Mark's incontinence scores were abstracted and analysed. From 1996 to 2014, 381 patients were considered for SNS. Of these, 256 patients met the study inclusion criteria. Median age at implantation was 52years (range 18-81). The ratio of women to men was 205:51. Indications were urge FI (25%), passive FI (17.9%) and mixed FI (57%). The median of the incontinence score at baseline was 19/24 and this improved to 7/24 at the 6-month follow-up. Of the total cohort, 235 patients received a medium-term follow-up (median 110months, range 12-270) with a median continence score of 10/24 which was also confirmed at the telephone long-term follow-up on 185 patients (132months, range 60-276). This study demonstrates that SNS is an effective treatment in the long term. SNS results in an improvement of validated scores for approximately 60% of patients; however, there is a significant reduction of efficacy over time due to underlying causes.

Comparison of long-term outcome of sacral nerve stimulation for constipation and faecal incontinence with focus on explantation rate, additional visits, and patient satisfaction

The aim of the present study was to compare sacral nerve stimulation (SNS) for constipation (SNS-C) with SNS for idiopathic faecal incontinence (SNS-IFI) regarding explantation rate, additional visits, and improvement of patient satisfaction 5years after implantation. From our prospective database (launched in 2009), we extracted all SNS-C patients 5years post-implantation, and the SNS-IFI patients implanted just before and just after each SNS-C patient. We retrospectively evaluated the explantation rate, number of additional visits, and patient satisfaction using a visual analogue scale (VAS). We hypothesized that compared with those in the SNS-IFI group: (1) the explantation rate would be higher in SNS-C patients, (2) the number of additional visits would be higher in SNS-C patients, and (3) in patients with an active implant at 5years, the improvement in VAS would be the same. We included 40 SNS-C patients and 80 SNS-IFI patients. In the SNS-C group 7/40(17.5%), patients were explanted, compared to 10/80(12.5%) patients in the SNS-IFI group (p = 0.56). The mean number of additional visits in the SNS-C group was 3.5 (95% CI 2.8-4.1)) and 3.0 (95% CI 2.6-3.6)) in the SNS-IFI group (p = 0.38). Additional visits due to loss of efficacy were significantly higher in the SNS-C patients (p = 0.03). The reduction in VAS score (delta VAS) at 5years was 37.1 (95% CI 20.9-53.3) in the SNS-C group, and 46.0 (95% CI 37.9-54.0) in the SNS-IFI group (p = 0.27). No significant difference was found regarding explantation rate, number of additional visits, or improvement of VAS at 5years after SNS implantation between SNS-C patients and SNS-IFI patients.

Sacral Nerve Stimulation in Parkinson's Disease Patients With Overactive Bladder Symptoms

ObjectiveTo assess the efficacy, safety, and outcomes of sacral nerve stimulation (SNS) for Parkinson's disease (PD) patients with overactive bladder symptoms. MethodsWe retrospectively reviewed PD patients who underwent Stage I SNS. Demographics, urodynamic data, and baseline voiding function were analyzed. Efficacy and safety of treatment were determined by rate of progression to Stage II, explantation, and surgical revision. Long-term outcomes were assessed using voiding diaries and/or clinic notes. ResultsSixty percent (9/15) experienced ≥50% improvement in urinary parameters and proceeded to Stage II. There was no significant difference in age, body mass index, comorbidities, PD disease duration, or levodopa equivalent daily dose between successful and nonsuccessful Stage I patients. However, 100% of female patients experienced Stage I success compared to 44% of male PD patients (P = .04). Individuals with >12-month follow-up experienced an average reduction of 6 voids/day. No patients required revision or explantation of their device at latest clinic follow-up (22.2 ± 7.8 months). Higher maximal urethral closure pressures, detrusor pressure at maximum flow rate (PdetQmax), post-void residual volume, and mean bladder outlet obstruction index were observed in the Stage I trial failures. ConclusionAt our institution, PD patients have a similar rate of progression to Stage II compared to the general population. SNS is an effective therapy that should be considered among the treatment options for PD patients with overactive bladder symptoms. Urodynamic parameters associated with obstruction may be predictive of SNS failure in PD patients and may help guide patient selection, however further studies are needed.

Costs and outcomes of sacral nerve stimulation for faecal incontinence in New Zealand: a 10-year observational study.

Faecal incontinence is a debilitating condition that affects more than 10% of New Zealanders. In well-selected cohorts, sacral nerve stimulation (SNS) offers a therapeutic option for patients refractory to conservative and other surgical treatments. The aim of this study was to define the clinical efficacy, rate of reinterventions and explants and healthcare costs associated with SNS in the New Zealand setting. Clinical records of all consecutive patients undergoing SNS at Auckland District Health Board between 2008 and 2019 were retrospectively reviewed and paired with the results of a postal survey to 100 patients who had retained the implant at August 2019. Over the 10-year period, 142 patients underwent stage 1 SNS, of which 126 (88.7%) progressed to a permanent implant and 108 (76.1%) had retained the implant at a median follow-up of 41.2 months. SNS therapy significantly reduced weekly faecal incontinence episodes (P < 0.001), medication use (P < 0.001) and pad use (P = 0.01) at median 41.2 months. Complications were common, with infections in 9.2%, lead fractures in 4.9% and component migrations in 12.7%. The probability of retaining the same battery at 6.3 years was >90%. In total, reintervetion was necessary in 41.5% of the cohort. SNS therapy was expensive, costing >NZ$30 000 for implantation, increasing to >NZ$46 000 if a further reintervention was required. SNS is an effective long-term therapy for faecal incontinence. However, it is expensive and associated with a high rate of reinterventions and explants.

Outcomes of Sacral Nerve Stimulation for Treatment of Refractory Overactive Bladder Among Octogenarians

Sacral nerve stimulation (SNS) is an effective treatment for refractory overactive bladder (OAB). However, advanced age is often cited as a reason to avoid SNS in the elderly. This study evaluates the safety and efficacy of SNS for refractory OAB among our octogenarian population. A retrospective review from a single institution was performed on all SNS lead placements from December 1998 to June 2017 for refractory OAB. Octogenarians were characterized as 80 years of age or older at the time of Stage I. Efficacy and safety were determined by the rate of progression to Stage II, subsequent need for multimodal therapy, and rate of surgical revision and explantation. All patients were followed for a minimum of 12 months. Of 374 patients in this study, 37 (9.9%) were octogenarians. There was no difference in gender, race, smoking history, or prior OAB treatment regimens between cohorts. The rate of progression to Stage II was 56.8% for octogenarians compared to 60.5% for nonoctogenarians (p = 0.66). The rate of surgical revision, explantation, and need for multimodal therapy did not differ between groups. Subgroup analysis of octogenarians did not reveal any significant differences between successful and nonsuccessful Stage I patients. The safety and efficacy of SNS was similar between cohorts. This result suggests that SNS is a safe and effective therapy that should be considered among the treatment options for refractory OAB in octogenarian patients. Further studies are needed to determine predictive factors of Stage I success in elderly patients.

Outcomes of treatment of faecal incontinence with sacral nerve stimulation – a Finnish multicentre study

The aim of this multicentre study is to report the results of sacral nerve stimulation (SNS) treatment for faecal incontinence (FI) in Finland and determine factors that could influence SNS treatment outcomes. This is a national multicentre study, involving all patients tested for SNS implantation in Finland from 1999 to 2017. Data were collected retrospectively from electronic patient archives and analysed for possible effects on treatment outcome. Of the 432 patients with FI tested for SNS, 365 were women. Three hundred and thirteen (72.5%) of the tested patients advanced to permanent implantation of a stimulator. A successful final treatment outcome, with subjective alleviation of FI, was reported by 59.3% of the patients at the end of follow-up (mean 2.4 years, range 8 days to 13.3 years). Patients with obstetric sphincter injury and idiopathic FI had more permanent stimulator implantations than patients with iatrogenic injury (P = 0.012). Male patients had significantly worse test phase outcomes than female patients (P < 0.001). Age did not influence treatment outcome (P = 0.446) CONCLUSION: Subjective final success of SNS treatment for FI was achieved in 59.3% of patients at a mean of 2.4 years. Gender and the aetiology of FI influenced the test phase and final treatment outcome of SNS treatment.

The functional outcome of sacral nerve stimulation for faecal incontinence can be improved by using lead model 3889 and a standardized implantation technique.

Sacral nerve stimulation has been recognized as an effective treatment option for faecal incontinence when conservative therapy has failed. Refinement of the procedural technique and the use of a curved stylet may improve the functional outcome. Our aim was to explore the relationship between lead model, functional outcome, stimulation amplitude and the need for extra visits during the first year of follow-up. Patient data from May 2009 to February 2017, which were prospectively collected in a local database, were extracted and analysed for differences between lead model and improvement in incontinence scores, stimulation amplitude and the need for additional visits during the first year of follow-up. A foramen lead model 3093(straight stylet) was used in 134 patients and lead model 3889(curved stylet) was used in 40 patients. There were no differences in baseline characteristics or incontinence scores. Comparing results between the two lead models we found that the improvement (delta value) in the Wexner score at 6months' follow-up (P=0.05) and the St Mark's score at 12months' follow-up (P=0.02) was greater in patients implanted with lead model 3889(curved stylet) compared with patients implanted with lead model 3093(straight stylet). Patients implanted with lead model 3889 (curved stylet) were less likely to have to alter the stimulation amplitude or pole configuration during the first year of follow-up (P=0.04). No difference was found for stimulation amplitude (P=0.170) or the need for additional visits (P=0.663). Lead model 3889 (curved stylet) improves functional results compared with lead model 3093 (straight stylet) during the first year of follow-up. Lead model 3889 (curved stylet) reduces the need for reprogramming but has no influence on stimulation amplitude or the number of additional visits required.

Surgery for constipation: systematic review and practice recommendations: Results V: Sacral Nerve Stimulation.

To assess the outcomes of sacral nerve stimulation in adults with chronic constipation. Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. Seven articles were identified, providing data on outcomes in 375 patients. Length of procedures and length of stay was not reported. Data on harms were inconsistently reported and heterogeneous, making estimates of harm tentative and imprecise. Morbidity rates ranged between 13 and 34%, with overall device removal rate between 8 and 23%. Although inconsistently reported, pooled treatment success was typically 57-87% for patients receiving permanent implants, although there was significant variation between studies. Patient selection was inconsistently documented. No conclusions could be drawn regarding particular phenotypes that responded favourably or unfavourably to sacral nerve stimulation. Evidence supporting sacral nerve stimulation is derived from poor quality studies. Three methodologically robust trials are have reported since this review and all have all urged greater caution.

Long-term results following sacral nerve stimulation for chronic constipation.

The long-term outcome of sacral nerve stimulation (SNS) for chronic functional constipation was assessed. Patients who received a definitive SNS implant for chronic functional constipation only (according to the Rome III criteria) and were followed up for at least 3years were included in this study. Slow transit constipation (STC) was distinguished from obstructed defaecation (OD) and mixed/undetermined constipation (MU). Constipation features, Cleveland Clinic Constipation score (CCCS) and SF-36 questionnaire data were collected; physiological tests were performed. Forty-two out of 61 patients suitable for SNS received a definitive implant (14 for STC, 15 for OD, 13 for MU). Following SNS device implantation (mean follow-up 51±15months), the baseline CCCS (17±6) dropped to 9±6 (P<0.001) and 47% of patients had an improvement in the CCCS of more than 50%. Such improvement was more significant in patients with OD. Anal pressures did not change, while threshold and urgency rectal sensation significantly decreased, in particular in patients with OD. All aspects of patients' health status (SF-36) improved significantly following SNS; this was more marked in patients with OD. Data from this study suggest that the clinical efficacy of SNS can be prolonged in constipated patients, but in both the preliminary diagnostic assessment and pathophysiological interpretation every effort should be made to select patients for SNS. Although SNS showed efficacy in a low percentage of patients with STC, patients with OD were more responsive.

Long-term outcomes of sacral nerve stimulation for faecal incontinence (Br J Surg 2015; 102: 407-415).

Long-term outcomes of sacral nerve stimulation for faecal incontinence (Br J Surg 2015; 102: 407-415).

Outcome of Sacral Nerve Stimulation for Fecal Incontinence at 5 Years

This study aimed to evaluate the outcome of sacral nerve stimulation (SNS) for fecal incontinence at 5 years after implantation and to identify predictors of sustained efficacy. There is a lack of knowledge about the long-term outcome of SNS for fecal incontinence. Prospectively collected data from patients who underwent implantation of an SNS device between 2001 and 2006 were reviewed. One hundred and one patients were available for outcome evaluation at 5 years. Sixty of 101 patients [42.6% on intention-to-treat (ITT) and 55.6% per protocol (PP)] reported a favorable outcome, 41 patients (ITT 29.1%; PP 38.0%) reported an unfavorable outcome, of whom 24 patients (ITT 17.0%; PP 22.2%) had their device explanted or permanently switched off before 5 years. Wexner incontinence scores improved significantly from a baseline median of 16 (range 6-20) to a median of 6 (range 0-20) at 3 months (P < 0.0001), and the improvement compared with baseline was maintained throughout the 5-year follow-ups (P < 0.0001).Age was a negative predictive factor [odds ratio (OR): 0.96 each year increase, 95% confidence interval (CI): 0.92-0.99; P = 0.016]. Positive predictors included improvement of urge incontinence episodes during percutaneous nerve evaluation (OR: 10.8; 95% CI: 1.72-132; P = 0.036), improvement of incontinence scores at 6 months from baseline (OR: 6.29; 95% CI: 1.33-34.3; P = 0.025), particularly improvement of incontinence scores from 3 to 6 months (OR: 41.5; 95% CI: 3.51-811; P = 0.007). Overall, 521 reportable events were recorded from 94 patients (93.1%). On an ITT analysis, 42.6% of patients reported favorable outcomes at 60 months. Patient's age, improvement of urge incontinence during PNE, and sustained efficacy during the first 6 months after implantation are some of the predictors identified.

Outcome of Sacral Nerve Stimulation for Fecal Incontinence in Patients Refractory to Percutaneous Tibial Nerve Stimulation

Percutaneous tibial nerve stimulation and sacral nerve stimulation are both second-line treatments for fecal incontinence, but the comparative efficacy of the 2 therapies is unknown. In our institution, patients with refractory fecal incontinence are generally treated with percutaneous tibial nerve stimulation before being considered for sacral nerve stimulation. The aim of this study was to assess the outcome associated with this treatment algorithm in order to guide future management strategies. All patients with fecal incontinence treated over a 3-year period with tibial nerve stimulation before receiving sacral nerve stimulation were identified from a prospectively recorded database. Demographics and pretreatment anorectal physiological data were available for all patients. This study was conducted at an academic colorectal unit in a tertiary center. Twenty patients (17 female:3 male, median age 55 (33-79) years) were identified to be refractory to percutaneous tibial nerve stimulation. Clinical outcome data were collected prospectively before and after treatment, including 1) Cleveland Clinic Florida-Fecal Incontinence scores and 2) number of incontinence episodes per week. The mean (±SD) pretreatment incontinence score (11.7 ± 3.5) did not differ from the mean incontinence score after 12 sessions of tibial nerve stimulation (10.9 ± 3.6, p = 0.42). All patients were subsequently counseled for sacral nerve stimulation, and 68.4% of them reported a significant therapeutic benefit with an improved incontinence score (7.7 ± 4.1, p = 0.014). This was a nonrandomized study with a relatively small number of patients Sacral nerve stimulation appears to be an effective treatment for patients who do not gain an adequate therapeutic benefit from percutaneous tibial nerve stimulation and, thus, should be routinely considered for this patient cohort.

Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence

Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed. Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.

Sacral nerve stimulation during pregnancy in patients with severe fecal incontinence

In recent years, sacral nerve stimulation (SNS) has been established as an effective treatment of fecal incontinence (FI) [1]. However, although this pathology affects predominantly women, sometimes those of childbearing age, its effect on the pregnancy is not known. A 28-year-old female, with severe FI following obstetric anal sphincter injury, was treated in our hospital with SNS after unsuccessful previous external anal sphincter repair. The incontinence status classified according to the Wexner score [2] was 19/20 before SNS treatment. A quadripolar electrode (Medtronic Model 3889) was placed under local anesthesia at the right S3 foramen based on the best sensory and motor response during the peripheral neural evaluation and connected via a percutaneous extension kit (Medtronic Model 3550-05) to an external test stimulation (Medtronic Model 3625). After 3 weeks of temporary stimulation, the number of incontinence episodes or days with incontinence decreased by over 50 % and the patient received the permanent stimulation generator (INTERSTIM II, Medtronic Model 3058) subcutaneously placed in a pocket created in the ipsilateral gluteal area. The Wexner score decreased to 0/20 after placement of the permanent stimulation generator. Three years later, the patient became pregnant, and against medical advice, she kept the stimulator activated for FI symptom control during the pregnancy. SNS did not seem to have any adverse effect during pregnancy. The patient had an uncomplicated pregnancy and a fullterm baby boy was delivered via vacuum extraction. After vaginal delivery, the functional results of SNS suddenly worsened. The patient developed passive fecal incontinence and her Wexner score was 16/20. After the amplitude and polarity stimulation were changed, the patient’s symptoms did not improve. An X-ray showed that the electrode was broken and displaced (Fig. 1). A new electrode was successfully implanted under local anesthesia. The patient recovered physiological continence and her Wexner score decreased to 0/20. There was no cessation of clinical response during the follow-up and no complications were observed. The safety of SNS in pregnancy has not been well established and pregnancy still is an exclusion criterion for SNS therapy. It is important to know that there are very few reports of this treatment in the pregnancy. To the best of our knowledge, we report the first case of use of SNS as treatment of FI in pregnancy, with a healthy newborn but with sacral electrode migration during vaginal delivery. Nanninga et al. [3] communicated the use of SNS to reduce bladder hyperreflexia and incontinence in a pregnant woman with myelodysplasia. They did not observe any adverse effects on the woman or during childbirth. El-Khawand et al. [4] reported the case of a 25-year-old woman who had SNS for severe interstitial cystitis and bladder pain syndrome. The woman kept the stimulator activated for symptom control during two pregnancies. Her first child was later diagnosed with chronic motor tic disorder, and the second had a pilonidal sinus at birth. In addition, the efficacy of SNS decreased after each pregnancy. Govaert et al. [5] showed some effect of SNS on uterine activity. In three premenopausal women, SNS seems to P. Moya J.-M. Navarro A. Arroyo A. Lopez J. Ruiz-Tovar R. Calpena Department of Surgery, University General Hospital of Elche, Alicante, Spain

Functional Outcome of Sacral Nerve Stimulation in Patients With Severe Constipation

Sacral nerve stimulation has been reported as an effective treatment for constipation. This study aimed to evaluate the therapeutic efficacy of permanent sacral nerve stimulation on the treatment of idiopathic constipation resistant to medical and behavioral management over a median follow-up period of 25.6 (range, 6-96) months. A retrospective review of a prospectively maintained institutional review board-approved database was performed. The study was performed at 2 tertiary-care European institutions with expertise in sacral nerve stimulation. Patients were considered eligible if they had had symptoms for at least 1 year and if conservative treatment had failed. Patients were tested by percutaneous nerve evaluation before the procedure. If this evaluation was successful, patients underwent sacral nerve therapy with an implanted device. Patients were evaluated by means of a bowel function diary and the Wexner constipation score. A total of 48 consecutive patients (39 females, median age 50.0 years (range, 17-79 years) entered the study. Twenty-three patients were implanted with a permanent stimulator. On an intention-to-treat basis, only 14 of 48 patients (29.2%) met the definition of a successful outcome at the latest follow-up period (median, 25.6 (range, 6-96) months). The mean Wexner score decreased from 20.2 (SD 3.6) at baseline to 5.8 (SD 4.1) at the latest follow-up examination (p < 0.001). However, 6 of 14 patients (42.8%) were still using laxatives and/or enemas at the last follow-up. The study was limited by the pragmatic approach necessary to evaluate the results in routine clinical practice. This study shows that sacral nerve stimulation has limited efficacy on an intention-to-treat basis as a routinely recommended therapy for intractable idiopathic constipation.

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.