Efficacy Of Sacral Neuromodulation Research Articles

Efficacy of sacral neuromodulation in the treatment of refractory overactive bladder and non-obstructive urinary retention –A preliminary report

Efficacy of sacral neuromodulation in the treatment of refractory overactive bladder and non-obstructive urinary retention –A preliminary report

Unsuccessful Progression of Sacral Neuromodulation From the Evaluation to the Implantation Stage: A Single-Center Experience.

IntroductionOver the years, sacral neuromodulation (SNM) has become an established and effective treatment for chronic urinary system retention and incontinence. The process of SNM is performed in two stages, the first is an evaluation phase and the second an implant phase. This study aimed to assess the rate of failure of progression from the evaluation to the implantation stage and the factors predicting the outcome of this commonplace procedure.Materials and methodsThis retrospective cross-sectional study took place at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. All the patients who underwent SNM implantation from January 1, 2016 to January 1, 2021 were included. Patients younger than 14 years and patients who had the SNM implantation in a different hospital and were only followed-up at KAMC were excluded. Patient-related information were extracted from the BESTCare system. Frequency and percentage were used for the categorical variables, and the mean, median, and standard deviation to display the continuous variables. Chi-square test and Mann-Whitney U test were used to test for the association of the categorical variables.ResultsAmong 28 patients, 46.4% (n=13) failed to progress from the evaluation phase to the implantation phase. Gender, age, having a co-morbidity, and SNM indication were not significant factors for predicting the outcome of the SNM evaluation phase.ConclusionThe observed failure rate was marginally higher than the ones detected in other studies. Although no significant association was detected between evaluation stage failure and the assigned predictors, the results need to be interpreted with caution due to the small population size. Larger multicenter studies need to be done in order to investigate the link between patient characteristics and the efficacy of SNM. Establishing a concrete evidence would further refine the targeted patient population and indications for SNM.

Efficacy of sacral neuromodulation and percutaneous tibial nerve stimulation in the treatment of chronic nonobstructive urinary retention: A systematic review.

The aim of this systematic review is to provide an updated report on the efficacy and complications of sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) in the treatment of chronic nonobstructive urinary retention (CNOUR), with a focus on the contemporary technique of SNM utilizing the percutaneous placement of tined leads. This systematic review was conducted with the use of PRISMA guidelines and registered with PROSPERO (CRD42020208052). A systematic literature search was conducted in Embase, PubMed, and Cochrane databases. Inclusion criteria include English language and human participants. Exclusion criteria include SNM studies involving less than 10 CNOUR patients, studies containing data obtained using open, surgical implantation of nontined leads, and studies that only reported the test phase success rate with no long-term efficacy data. The risk of bias assessment was conducted using the National Institutes of Health study quality assessment tool. A total of 16 papers studies were included (11 SNM and 5 PTNS) in this review. The success rate for SNM ranges between 42.5% and 100% (median = 79.2%) for the test stimulation phase and 65.5%-100% (median = 89.1%) in the long term. Most SNM studies reported revision and explantation rates of lesser than 20%. The success rate was much lower for PTNS, in the 50%-60% range and complications were minimal. SNM using the contemporary percutaneous tined lead implantation technique appears to be an effective treatment for CNOUR and is durable in the long term. Compared to SNM, PTNS appears less efficacious with less evidence supporting its use in CNOUR. Further prospective studies are required to define the role of PTNS in the treatment of CNOUR.

The Safety and Efficacy of Sacral Neuromodulation on Refractory Urgency Urinary and Fecal Incontinence in Iraqi Patients

Background: Urinary urgency incontinence is characterized by symptoms of involuntary loss of urine thatpreceded or accompanied by sudden desire to void. Fecal incontinence is defined as involuntary passage ofstool through the anus. It may vary from soiling to complete evacuation. This involuntary loss of feces, flatusor urge incontinence adversely affects quality of life.Objectives: To evaluate the efficacy and safety of sacral neuromodulation on these pathologies.Method: Following a detailed investigation, 21 patients with either urinary incontinence, or both urinaryand fecal, who did not respond to medical and behavioral treatment were offered the sacral neuromodulationtherapy and followed for at least 12 months post implant regarding response and development of complicationif any found.Results: In the period from November 2015 to May 2017. The unit of neurogenic bladder and neuromodulationin surgical subspecialty hospital, medical city complex had implanted 21 Patients with urinary incontinencewere using from (4-17) pads/day (mean of 10.5/day) presacral neuromodulation which were declinedsignificantly to (0-3) pads/day (mean of 2.2/day).From the eighteen patients who presented with fecal incontinence after the implantation of sacralneuromodulation interstim 11 permanent devices only four remained incontinent .and from the nine patientswho presented with erectile dysfunction only two remained impotent.Conclusion: The use of Sacral Neuromodulation in Iraqi patients with Urinary and Fecal Incontinence issafe and effective

The efficacy of sacral neuromodulation in the treatment of low anterior resection syndrome: a systematic review and meta-analysis.

Sacral neuromodulation (SNM) has become one of the main treatment options in patients with fecal incontinence. The aim of this study was to determine the efficacy of sacral neuromodulation in the treatment of low anterior resection syndrome (LARS). A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The search was conducted using the Pubmed, Embase, Ovid, and Cochrane databases, restricted to the English language and to articles published from 2000 to November 2018. A total of 434 articles on the efficacy of SNM in the treatment of LARS were retrieved, and 13 studies were included in the final analysis, with a total of 114 patients treated with SNM for LARS The overall success rate excluding study heterogeneity was 83.30% [95% CI (71.33-95.25%)]. Improvement in anal continence was seen in several clinical and functional parameters, including the Wexner Score [10.78 points, 95% CI (8.55-13.02), p < 0.0001], manometric maximum resting pressure [mean improvement of 6.37mm/Hg, 95% CI (2.67-10.07), p = 0.0007], maximum squeeze pressure [mean improvement of 17.99mm/Hg, 95% CI (17.42-18.56), p < 0.0001] and maximum tolerated volume [mean improvement of 22.74ml, 95% CI (10.65-34.83), p = 0.0002]. Quality of life questionnaires also demonstrated significant improvement in patients' quality of life, but were reported only in a small group of included patients. SNM significantly improves symptoms and quality of life in patients suffering from fecal incontinence following low anterior resection.

What uro-gynecologists should know about sacral neuromodulation (SNM) for the treatment of refractory overactive bladder.

To inform uro-gynecologists about the current standards and latest developments of sacral neuromodulation (SNM) in women with overactive bladder (OAB). Literature search in the PubMed database for articles published between 1988 and 2019 on SNM for OAB in women. In total, 361 articles were identified and 51 articles retrieved for the review. SNM shows an objective success rate of 70-80%, OAB cure rate of 17-47% and a subjective satisfaction rate of 80-90%. These benefits have to be weighed against an adverse event rate of approx. 40%. SNM is significantly more successful than switching to another antimuscarinic after failed antimuscarinic drug therapy. Efficacy of SNM is slightly lower compared to bladder wall injections with 200U botulinum toxin in the first months but efficacy of both treatments appears to be similar after 24months. MRI examinations of patients with a sacral neurostimulator should only be performed after radiologist consultation. Sacral neurostimulators in patients with another pacemaker system should only be implanted after interdisciplinary consultation. The sacral neuromodulator should be turned off during pregnancy and delivery. SNM for OAB in patients with concomitant female sexual dysfunction or fecal incontinence seems to be beneficial. SNM is a successful and recommended second-line treatment of OAB. Sacral neurostimulators should preferably be implanted in SNM-centers because complications and the frequency of revisions are significantly reduced with increasing experience of the surgeon.

Sacral neuromodulation in congenital lumbo-sacral and traumatic spinal cord defects with neurogenic lower urinary tract symptoms: a single-center experience in children and adolescents.

This study evaluated sacral neuromodulation's effectiveness for managing refractory neuropathic lower urinary tract dysfunction in children and adolescents. Twenty-five children and adolescents underwent peripheral nerve evaluation test phase of sacral neuromodulation at our center. Thirteen (seven boys and six girls) cases suffered from neuropathic lower urinary tract dysfunction refractory to the maximum medical treatment. The test was done with temporary wire in all patients. Patients with more than 50% improvement in symptoms were chosen for the second stage of implantation of quadripolar tined lead and implantable pulse generator. Bowel transit symptoms were recorded before and after the surgery. Eight patients (61.53%; five boys and three girls) had positive responses to the peripheral nerve evaluation test phase. They underwent implantation of permanent quadripolar tined lead and implantable pulse generator. The etiologies were lumbosacral myelomeningocele, occult spina bifida, partial sacral agenesis and incomplete spinal cord injury. Positive clinical response (> 50% improvement in symptoms) was achieved in seven (85%) at a mean follow-up of 14.25months. Three patients became capable to stop clean intermittent catheterization (P =0.125). The 24-h pad test decreased from 484 to 78g from before to after the surgery (P =0.043). This clinical study on a small sample size of children and adolescents demonstrates positive results in short-term follow-up. However, as the procedure is still not approved officially, multicenter studies with more patients can prove the safety and efficacy of sacral neuromodulation in long term among this special group of patients.

Sacral neuromodulation blocks pudendal inhibition of reflex bladder activity in cats: insight into the efficacy of sacral neuromodulation in Fowler's syndrome.

This study tested the hypothesis that sacral neuromodulation, i.e., electrical stimulation of afferent axons in sacral spinal root, can block pudendal afferent inhibition of the micturition reflex. In α-chloralose-anesthetized cats, pudendal nerve stimulation (PNS) at 3-5 Hz was used to inhibit bladder reflex activity while the sacral S1 or S2 dorsal root was stimulated at 15-30 Hz to mimic sacral neuromodulation and to block the bladder inhibition induced by PNS. The intensity threshold (T) for PNS or S1/S2 dorsal root stimulation (DRS) to induce muscle twitch of anal sphincter or toe was determined. PNS at 1.5-2T intensity inhibited the micturition reflex by significantly ( P < 0.01) increasing bladder capacity to 150-170% of control capacity. S1 DRS alone at 1-1.5T intensity did not inhibit bladder activity but completely blocked PNS inhibition and restored bladder capacity to control level. At higher intensity (1.5-2T), S1 DRS alone inhibited the micturition reflex and significantly increased bladder capacity to 135.8 ± 6.6% of control capacity. However, the same higher intensity S1 DRS applied simultaneously with PNS, suppressed PNS inhibition and significantly ( P < 0.01) reduced bladder capacity to 126.8 ± 9.7% of control capacity. S2 DRS at both low (1T) and high (1.5-2T) intensity failed to significantly reduce PNS inhibition. PNS and S1 DRS did not change the amplitude and duration of micturition reflex contractions, but S2 DRS at 1.5-2T intensity doubled the duration of the contractions and increased bladder capacity. These results are important for understanding the mechanisms underlying sacral neuromodulation of nonobstructive urinary retention in Fowler's syndrome.

Neuromodulation in the Treatment of Voiding Dysfunction and Fecal Incontinence in Male and Female Cancer Survivors

Sacral neuromodulation (SNM) is a widely accepted and minimally invasive treatment for several urologic lower urinary tract pathologies and bowel dysfunction. Treatment for pelvic malignancies is associated with significant rates of urinary, sexual, and fecal dysfunction. The authors sought to determine the role SNM should play in the management of voiding and fecal dysfunction in the male and female cancer survivor patient. There is a lack of studies looking at SNM in the cancer survivor population, particularly in the setting of radiation cystitis or proctitis. Regardless, the authors feel there is a role for SNM in this population. Further studies are needed to further delineate this role and the efficacy of SNM in this challenge to treat patient population. Voiding dysfunction in the cancer survivor population including urinary urgency, frequency, and urge incontinence is very common. Similarly, fecal incontinence occurs not infrequently and is a major source of patient distress. There is great evidence for SNM via InterStim in urinary urgency, urge incontinence, non-obstructive retention, and fecal incontinence. Studies are lacking, however, in the cancer survivor population. They are non-existent in the postradiation patient population. SNM is a good treatment option for urinary urgency, urge incontinence, non-obstructive urinary retention, and fecal incontinence. More studies are needed in the cancer survivor population, particularly following radiation therapy. Regardless, the authors feel there is a role in the cancer survivor for SNM.

Long-term outcome of sacral neuromodulation in patients with idiopathic nonobstructive urinary retention: Single-center experience.

Objective:The objective of this study was to determine the safety and efficacy of sacral neuromodulation (SNM) in patients with idiopathic nonobstructive urinary retention.Materials and Methods:We retrospectively reviewed the files of patients who underwent staged neuromodulation for idiopathic nonobstructive urinary retention from 2004 to 2016 at our hospital. Patients who had a 50% improvement in symptoms after 1 week of stage 1 procedure were qualified for permanent device implantation. Patient data were assessed on efficacy and need for intermittent self-catheterization, complications, and operative revision rates.Results:Twenty-seven female patients who underwent SNM therapy were analyzed. The mean age of the patients was 32.5 ± 10.8 years. The mean duration of urinary retention was 3.2 ± 1.7 years. All patients were doing intermittent self-catheterization, but few were able to void <100 ml. Twenty-four (88.8%) of the 27 patients demonstrated a >50% improvement in symptoms and underwent permanent device placement. At a median follow-up of 5.7 ± 3.2 years, 20 (83.3%) of the 24 patients demonstrated sustained improvement rates of >50%. Seventeen (70.83%) of 24 patients could void spontaneously with a mean residual urine of 28.1 ± 24.4 ml (P < 0.001). Three (12.5%) were voiding with significant mean decreasing number of catheterizations from 5.6 ± 2.4 to 1.4 ± 2.1 (P < 0.001). Four (16.6%) had their device explanted. Ten (41.6%) of the 24 patients underwent surgical revision. Most of the adverse events were managed by device reprograming.Conclusion:SNM is a highly effective and safe procedure in this subset of the female population with idiopathic refractory nonobstructive urinary retention.

Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder

This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included. Subjects with successful test stimulation received an SNM implant. Therapeutic success (≥50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects. Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1 ± 2.7 leaks/day, UF subjects had 12.6 ± 4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2 ± 2.7 leaks/day; UF subjects had a mean reduction of 5.1 ± 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant. This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications.

Sacral neuromodulation in the treatment of intractable constipation

To assess the efficacy of sacral neuromodulation (SNM) in patients with intractable constipation. A total of 7 patients with intractable constipation were treated with pereutaneous test stimulation of the S3 nerve root and were assessed by sacral never stimulation system in our department from January 2013 to January 2014. Four of these 7 patients received operation for constipation before. The efficacy was assessed by bowel habit diary, clinic constipation scores, subjective questionnaire and clinical signs. The constipation symptoms were improved significantly in all the 7 patients. The frequency and volume of defecation per week were increased obviously, and the average urine was increased. Six patients underwent permanent implantation of the SNS system. After a median 4 months follow-up, the defecation frequency increased from 0.6 ± 0.5 to 8.0 ± 2.5 per week (P<0.01), and the defecation time decreased from (22.9 ± 11.5) to (3.7 ± 0.8) min (P<0.01). The Cleveland clinic constipation score decreased from 24.6 ± 4.2 to 9.0 ± 0.9 (P<0.01), and the visual analogue scale(VAS) score increased from 8.1 ± 0.9 to 82.5 ± 5.2 (P<0.01). SNM is a clinically efficacious, minimally invasive and safe new technique, which offers an alternative treatment for the patients with intractable constipation resistant to conservative treatment, especially for the patients refractory to traditional operations.

Effects of stimulation frequency and intensity in sacral neuromodulation on anorectal inputs to the somatosensory cortex in an experimental model.

Although sacral neuromodulation (SNM) is an established treatment for faecal incontinence, stimulation parameters have been derived empirically and only one frequency (14 Hz) is employed clinically. The aim of this study was to test a range of stimulation frequencies to establish an optimal frequency of SNM for maximum augmentation of anal canal cortical evoked potentials (EPs) in an animal model. In female Wistar rats, anal canal EPs were recorded over the primary somatosensory cortex using a flexible multielectrode array, and the effect of SNM was studied. SNM was applied at 0·1-100 Hz and a frequency response curve plotted. The data were fitted to a quadratic equation. The magnitude of potentiation of anal canal EPs caused by SNM depended significantly on stimulation frequency (P < 0·001). The frequency-potentiation relationship was parabolic in form, with a clear optimum at 2 Hz. The SNM must be applied for at least 3 min. The theoretical maximal potentiation predicted by the model was not found to be statistically different to actual data recorded (P = 0·514-0·814). The response depended on stimulation amplitude in an 'all-or-nothing' fashion. EPs were augmented when the SNM intensity was 0·5 times the motor threshold to tail twitch or greater, but values below this intensity failed to affect the EPs. The effect of SNM in this animal model is governed principally by frequency, with an optimum of 2 Hz. If animal data can be translated to humans, optimization of SNM frequency may offer a clinically relevant improvement in the efficacy of SNM. Surgical relevance Sacral neuromodulation (SNM) for faecal incontinence currently employs stimulation parameters that have been derived empirically and may not be optimal. This study used an animal model of SNM and focused on its acute effect on anal canal cortical evoked potentials (EPs). It was found that SNM potentiated EPs, with a clear optimum at a frequency of 2 Hz. If this finding is applicable to the mechanism of action of human SNM, this suggests that there may be a clinically relevant improvement by reducing stimulus frequency from its typical value of 14 Hz to 2 Hz.

Efficacy of Sacral Neuromodulation on Urological Diseases: A Multicentric Research Project

Sacral neuromodulation has been used as a safe, effective treatment option for patients with lower urinary tract dysfunction (LUTD). Several clinical studies demonstrated its positive effects on refractory urge incontinence, non-osbstructive urinary retention, urgency frequency syndrome, as well as on other non- urological disorders, such as fecal incontinence and chronic constipation. The aim of this research project was to evaluate the efficacy and safety of sacral neuromodulation on the management of LUTD refractory to the standardized first line treatment options. We retrospectively collected and evaluated data from patients undergoing sacral neuromodulations between September 2001 and November 2010 in 4 Urological Centres of North-East Italy. The patients were affected by Overactive Bladder Syndrome (OAB), Urinary Retention (UR), Fecal Incontinence (FI), Constipation (CO), Chronic Pelvic Pain (CPP). All the patients were evaluated with voiding diaries, before and after implantation.Patients included in the present evaluation were followed up in a network of 4 Italian urological centres, which participate to in the Italian Clinical Service project - a national urological database and medical care project aiming at describing and improving the use of implantable urological devices in the Italian clinical practice. Continuous normally distributed variables were reported as the mean value ± standard deviation (SD). Continuous non-normally distributed variables were presented as the median values and an interquartile range (IQR). The t-test and Wilcoxon test were used to compare continuous variables, as appropriate. A two-sided p <0.05 was considered statistically significant. Overall, 157 patients underwent implantation of sacral neuromodulator during the period under review. Eighty-three out of 157 (53%) patients complained of OAB; 52 (33%) of UR; 5 (3%) of faecal incontinence; 4 (2%) of chronic constipation; 12 (8%) of CPP. The median follow- up was 11 months (IQR 1 - 91 months). In patients treated for OAB, we documented a statistically significant reduction in the mean number of: incontinence episodes/die, pads/die, daily micturitions, nocturnal micturitions and global micturitions. In patients treated for UR, we observed a statistically significant reduction in the mean post- voiding residual volume and in the number of self catheterization. Interpretation of results: It is difficult to translate into quantifiable data the subjective perception of improvement of the symptoms expressed by the patients, as they are frequently subjective perceptions, not always numeric data. This subjective perception makes it difficult to the clinician to evaluate the real outcomes of this procedure, and makes it difficult to achieve a complete follow-up. This multicenter research project confirmed the midterm safety and effectiveness of sacral neuromodulation in the treatment of refractory overactive bladder syndrome and urinary retention, showing high cure rates and low complication rates.

Efficacy of sacral neuromodulation in treating chronic pain related to painful bladder syndrome/interstitial cystitis in adults

Objective:The objective of this review is to evaluate the efficacy and safety of sacral neuromodulation in treating chronic pelvic pain related to Painful bladder syndrome/Interstitial-cystitis.Design:The databases searched were MEDLINE and EMBASE [1950- Nov 2011]. Additional searches were performed on the Cochrane Database of Systematic reviews (CDSR), Scopus, CINAHL, BIOSIS, The Cochrane controlled trials register, the science citation index, TRIP DATABASE.Results:Overall 70.8% or 170/244 patients were successful at the trial stage. The only randomized controlled trial reported a decrease in Visual analogue pain scores of 49% (7.9 to 4.0) for sacral nerve stimulation [SNS] and 29%(4.5 to 3.2) for pudendal nerve stimulation [PNS] at 6 months follow up. Nine observational studies reported a decrease in pain scores/decrease in pain medications at long term follow up following permanent sacral neuromodulation. One study showed an 80% improvement in Global response assessment score.Conclusion:The results from the randomised controlled trial and case series/case reports demonstrate a reduction of pain symptoms of Painful bladder syndrome following sacral neuromodulation

Efficacy of sacral neuromodulation in treatment of bladder pain syndrome: Long‐term follow‐up

This study was sought to evaluate the efficacy and durability of sacral neuromodulation in the treatment of bladder pain syndrome (BPS) patients. A retrospective chart review was performed of patients who had unilateral sacral nerve stimulator (InterStim®) for refractory BPS between June 2002 and December 2004. Patients were qualified for permanent implantation by showing ≥ 50% improvement in their bladder pain and voiding symptoms 1-week post-percutaneous nerve evaluation (PNE). Voiding diary was completed at pre-implantation, 1 year, and on the last visit. Urinary distress inventory short form was completed pre-implantation and on the last visit. Bladder pain was evaluated by visual analogue scale. Primary outcome was improvement in bladder pain. Differences among groups were compared by one-way ANOVA and t-test. Statistical significance was set at P ≤ 0.05. Twenty-one female patients diagnosed with BPS had PNE; 11 patients (52%) showed ≥ 50% improvement in their bladder pain and voiding symptoms and they consider candidates for permanent implantation (Table I), while 10 patients (48%) failed to show 50% improvement in their voiding symptoms or bladder pain (Table II). In those 11 patients who underwent permanent implantation, the average patient's age was 44.3 ± 8.9 years; average time since diagnosis was 3 ± 0.8 years; the average follow- up was 71.5 ± 9.3 months (Table III). There was significant improvement in the bladder pain and voiding parameters at 1-year follow-up, which was maintained at 5-year follow-up. There was continuous improvement in urgency (1.2 ± 0.68) at 1-year follow-up, and (0.98 ± 0.72) at the last visit. Average voided volume was also continuously improved from 242 ± 62.7 ml at 1-year follow-up to 276 ± 64.7 ml on the last visit. Sacral neuromodulation as part of multimodal treatment provides an effective long-term treatment option for sub-group of refractory BPS.

The long‐term efficacy of sacral neuromodulation in the management of intractable cases of bladder pain syndrome: 14 years of experience in one centre

Study Type--Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? Bladder pain syndrome (BPS) is a chronic debilitating disease. A recently done survey estimates the prevalence of the BPS symptoms among adult females in the U.S. to be 7%. Conservative management is the first line of therapy but at least 10% of the patients show poor response. Sacral neuromodulation is a minimal invasive technique with good long-term outcomes in these patients. It should be considered before any invasive surgical intervention is planned. However, the revision rate is high and patients need lifelong follow-up. • To evaluate the long-term success and tolerability of sacral neuromodulation (SNM) in the control of the symptoms of bladder pain syndrome (BPS). • This was a retrospective study of all patients with BPS who underwent peripheral nerve evaluation and then SNM in our department of urology by a single surgeon from 1994 till 2008. The global response assessment scale was used to evaluate the outcome of the SNM. • A total of 78 patients fulfilled the International Consultation on Incontinence clinical criteria for BPS and showed cystoscopic evidence of glomerulation or ulcer as recommended by the European Society for the Study of Interstitial Cystitis/Painful Bladder Syndrome. All patients failed conservative management before considering SNM. • Permanent SNM implant was performed in patients who showed at least 50% improvement in their symptoms with a temporary peripheral nerve evaluation test. Median follow up was 61.5 months (SD ± 27.7). Good long-term success of the SNM was seen in 72% of the patients. • Presence of urgency was a positive predictor of the long-term success of the implant. The explantation rate was 28%. The commonest reason for explantation was poor outcome (54% of the failed patients). The revision rate was 50%. • The most common indication for revision was lack of stimulation sensation and worsening of symptoms. The average durability of the pulse generator battery was 93 months. • SNM is an effective treatment to control the symptoms of BPS. It should be considered before any major invasive surgical intervention if conservative measures have failed. It is a minimally invasive, safe procedure with good long-term outcome. However, the revision rate is high and patients require lifelong follow-up.

Sacral Neuromodulation for Nonobstructive Urinary Retention

: The objective of this study is to systematically review the literature regarding the efficacy of sacral neuromodulation (InterStim) for treatment of nonobstructive urinary retention. : Eligible studies were selected through an electronic literature search of PubMed, Cochrane Collaboration, EMBASE, Web of Science and Scopus databases from January 1980 to August 2008. Two investigators independently reviewed all studies to assess methodological quality and inclusion criteria. Eligible studies evaluated sacral neuromodulation using implanted generators with permanent lead placement for treating nonobstructive urinary retention. The primary outcomes assessed were the change in pre- and postoperative postvoid residual and voided volume. Exclusion criteria were neurogenic etiology (ie, spinal cord injury) for urinary retention and non-English studies. The lead authors of all selected studies were contacted to identify ongoing or unpublished research, as was Medtronic, Inc. (Minneapolis, MN). Data were extracted from the selected studies and analyzed using RevMan 5 (Review Manager, Cochrane Collaboration, 2008). The mean difference with a 95% confidence interval was the effect of interest. : A total of 14 articles met all inclusion criteria for the systematic review. This included one randomized control trial (RCT) and 13 observational studies. Outcome data was available from a total of 7 studies and used in the final analysis. After implantation, the mean difference in postvoid residual decreased 236 mL (95% CI: 219-253, P < 0.00001) and voided volume increased by 299 mL (95% CI: 280-318, P < 0.00001). The randomized control trial alone (n = 51) showed a mean decrease in postvoid residual volume in the implanted group compared with control of 270 mL (95% CI: 180-360, P < 0.00001) and a mean increase in voided volume of 104 mL (95% CI: 55-152, P < 0.0002). : Based on the available literature, sacral neuromodulation is an effective therapy for treatment of nonobstructive urinary retention.

Is Sacral Neuromodulation for Fecal Incontinence Worthwhile in Patients With Associated Pelvic Floor Injury?

It has been shown that vaginal delivery may result in pelvic floor injury. Until now it is unknown whether this type of injury plays a role in the etiology of fecal incontinence and whether it affects the outcome of treatment. The aim of the present study was to assess the prevalence of pelvic floor injury in patients with fecal incontinence who were eligible for sacral neuromodulation and to determine whether sacral neuromodulation is worthwhile in patients with pelvic floor injury. All women with fecal incontinence who were eligible for sacral neuromodulation in the past were invited to participate in the present study. With transperineal ultrasound, which has been developed recently, pelvic floor integrity was examined in 46 of the 66 patients (70%). Follow-up was obtained from a standardized questionnaire. Pelvic floor injury was found in 29 of the 46 participants (63%). No differences regarding the efficacy of sacral neuromodulation were found between patients with and those without pelvic floor injury. Successful test stimulation was obtained in 86% of the patients with pelvic floor injury and in 71% of the patients without pelvic type injury. After implantation of a definitive pulse generator, a successful outcome was found in 84% of the patients with pelvic floor injury and in 75% of the patients with an intact pelvic floor. Pelvic floor injury is present in the majority of incontinent patients who were eligible for sacral neuromodulation. This type of injury seems to have no detrimental effect on the treatment outcome.

Results of Sacral Neuromodulation Therapy for Urinary Voiding Dysfunction: Outcomes of a Prospective, Worldwide Clinical Study

This 5-year, prospective, multicenter trial evaluated the long-term safety and efficacy of sacral neuromodulation in patients with refractory urge incontinence, urgency frequency and retention. A total of 17 centers worldwide enrolled 163 patients (87% female). Following test stimulation 11 patients declined implantation and 152 underwent implantation using InterStim. Of those treated with implantation 96 (63.2%) had urge incontinence, 25 (16.4%) had urgency frequency and 31 (20.4%) had retention. Voiding diaries were collected annually for 5 years. Clinical success was defined as 50% or greater improvement from baseline in primary voiding diary variable(s). Data for all implanted cases were reported. For patients with urge incontinence mean leaking episodes per day decreased from 9.6 +/- 6.0 to 3.9 +/- 4.0 at 5 years. For patients with urgency frequency mean voids per day decreased from 19.3 +/- 7.0 to 14.8 +/- 7.6, and mean volume voided per void increased from 92.3 +/- 52.8 to 165.2 +/- 147.7 ml. For patients with retention the mean volume per catheterization decreased from 379.9 +/- 183.8 to 109.2 +/- 184.3 ml, and the mean number of catheterizations decreased from 5.3 +/- 2.8 to 1.9 +/- 2.8. All changes were statistically significant (p <0.001). No life threatening or irreversible adverse events occurred. In 102 patients 279 device or therapy related adverse events were observed. At 5 years after implantation 68% of patients with urge incontinence, 56% with urgency frequency and 71% with retention had successful outcomes. This long-term study demonstrates that InterStim therapy is safe and effective for restoring voiding in appropriately selected cases refractory to other forms of treatment.