Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial

OBJECTIVES: To compare the effectiveness of sacral root neuromodulation with that of conservative management in ameliorating symptoms of refractory urinary urge incontinence and enhancing quality of life, to assess the objective response to neuromodulation as revealed by urodynamic testing, and to delineate the long-term outcomes of neuromodulation. METHODS: Forty-four patients with refractory urge incontinence were randomized to undergo neuromodulation with an implantable impulse generator (n = 21) or to continue their prior conservative management (n = 23). At 6 months the control group was eligible for crossover to implant. Patient evaluation included voiding diaries, quality of life questionnaires, urodynamic testing, and documentation of adverse events. Long-term follow-up evaluations were conducted at 6-month intervals up to 36 months. RESULTS: At 6 months mean leakage episodes, leakage severity and pad usage in the implant group were significantly lower by 88% (p < 0.0005), 24% (p = 0.047) and 90% (p < 0.0005), respectively, than the corresponding control group mean values. Improvements in leakage episodes and pad usage of >/=90% were attained by 75 and 85% of the implant group, respectively, but none of the control group. One third of implant patients, but none of the control patients, achieved >/=50% improvement in leakage severity. Over half of the implant patients (56%) were completely dry compared with 1 control patient (4%). Implant patients, but not control patients, exhibited significant improvement with respect to two quality of life measures. Neuromodulation resulted in increases of 220% (p < 0.0005) and 39% (p = 0.013), respectively, in urodynamically assessed bladder volume at first contraction and maximum fill. At 36 months the actuarial rate of treatment failure was 32.4% (95% CI, 17.0-56.0%). Adverse events most frequently involved pain at the implant site, and the incidence of serious complications was low. CONCLUSIONS: Neuromodulation is markedly more effective than conservative management in alleviating symptoms of refractory urge incontinence. Quality of life and urodynamic function are also improved by neuromodulation. The effects of neuromodulation are long-lasting, and associated morbidity is low.     

Sacral neuromodulation for refractory detrusor overactivity in women with an artificial urinary sphincter

PURPOSE: We assessed the efficacy of sacral neuromodulation as an alternative therapeutic option in women with an artificial urinary sphincter (AUS) who had de novo irritative urinary symptoms (urgency/frequency) refractory to conventional treatment. MATERIALS AND METHODS: Between 1984 and 2002 we implanted an AUS in 350 women and detrusor overactivity developed in 14. Six of the 14 patients responding positively to a percutaneous nerve evaluation test (greater than 50% subjective/objective improvement) were implanted with an S3 neuromodulator within 42.8 weeks (range 21 to 106) of AUS implantation. Followup included analysis of the voiding diary, a pad test and urodynamic assessment. RESULTS: After 30.5 months followup (range 14 to 40) 1 patient was dry, 4 were improved and treatment failed in 1. At 12 months mean voiding frequency daily had decreased from 17 (range 12 to 23) to 8 (range 4 to 12) and the mean number of leakages episodes daily had decreased from 14.7 (range 8.5 to 17) to 6 (range 4 to 10). Mean voided volume had increased from 121.7 (range 90 to 170) to 180 ml (range 120 to 225), mean first desire to void volume had increased from 117 (range 88 to 190) to 183 ml (range 130 to 275) and mean functional bladder capacity had increased from 325 (range 200 to 530) to 372 ml (range 250 to 580). Uninhibited bladder contractions had resolved in 4 of 5 patients. CONCLUSIONS: In women who already have an AUS with urge incontinence sacral neuromodulation can help resolve symptoms. Because this therapy does not compromise the potential for future treatment, it appears to be an alternative option in these patients. It can postpone or avoid more mutilating surgery and self-catheterization.     

Sacral neuromodulation for treatment of lower urinary tract dysfunction

Despite initial reservations, sacral neuromodulation has begun to develop as a new therapeutic tool for the treatment of lower urinary tract dysfunction. It bridges the gap between conservative treatment options and highly invasive procedures, such as urinary diversion. At present, there are no clinical variables that can reliably predict the efficacy of neuromodulation in an individual patient. All patients, regardless of indication, must therefore undergo a test stimulation before they can be offered chronic sacral neuromodulation with an implanted system. Evaluations in various clinical trials have confirmed that sacral neuromodulation, based on unilateral sacral foramen electrode implantation, has statistically significant therapeutic effects compared to controls, in patients with urge syndromes and failure to empty. The patients most likely to benefit from this treatment are those with detrusor hyperactivity or detrusor hypo-activity. Those with pain syndromes are less likely to respond and to benefit from treatment. Acute and subchronic sacral neuromodulation are associated with very low rates of complications. Complications of chronic sacral neuromodulation are caused either by surgery-related morbidity or hardware problems. Conservative treatment options should be exhausted before neuromodulation is considered. This rule has two purposes: First, it postpones surgery, with its potential morbidity, for as long as possible; second, the long-term efficacy of neuromodulation is still unclear and may be limited in some patients. A fully exploited conservative therapy, in combination with subsequent sacral neuromodulation, may therefore be the optimum way to pursue therapeutic options of relatively low invasiveness.     

Sacral neuromodulation for combined faecal and urinary incontinence following obstetric anal sphincter injury

Aim

The aim of this study was to investigate the efficacy of sacral neuromodulation (SNM) in the treatment of faecal incontinence and concomitant urinary incontinence in women with a history of obstetric anal sphincter injury (OASIS).

Method

In this prospective study, consecutive women with faecal incontinence following OASIS accepted for SNM were screened for concomitant urinary incontinence. The primary outcome was the change in urinary incontinence score on the International Consultation on Incontinence Questionnaire for Urinary Incontinence, Short Form (ICIQ‐UI‐SF), between baseline and 12 months. Secondary outcomes included the change in St Mark's score, sexual function and quality of life, change in grade of urinary incontinence and disappearance of urgency.

Results

From March 2012 to September 2014, 39 women with combined faecal incontinence and urinary incontinence received SNM. Thirty‐seven women were available for analysis after 12 months. The mean reduction in the ICIQ‐UI‐SF score between the baseline and 12 months was 5.8 (95% CI 3.7–8.0, P < 0.001). ICIQ‐UI‐SF was reduced in 29 (78%) women, urinary incontinence resolved in 13/37 (35%, 95% CI 20%–50%) patients, and urgency disappeared in 14/33 (42%, 95% CI 26%–59%). The mean reduction in the St Mark's score was 10.6 (95% CI 8.6–12.7, P < 0.001). Disease‐specific quality of life, Euroqual 5‐dimension visual analogue scale (EQ‐5D VAS) and several areas of sexual function changed significantly for the better.

Conclusion

More than three‐quarters of the women with combined faecal and urinary incontinence following OASIS reported a successful outcome with reduction in ICIQ‐UI‐SF at 12 months after SNM.     

Sacral neuromodulation stimulation in fecal incontinence

Fecal incontinence (FI) is a common problem treated by many different interventions. No treatment is optimal. Based on its success for urinary incontinence, sacral nerve stimulation (SNS) has been used successfully outside the United States for FI. In direct comparison with standard medical treatment or the artificial bowel sphincter, SNS overall appeared superior. Currently, SNS is awaiting FDA approval in the United States.     

Sacral neuromodulation for lower urinary tract dysfunction

Objectives

To review the technique, indications, results and working mechanisms of sacral neuromodulation (SNM) for lower urinary tract dysfunction.

Methods

The available literature on SNM for lower urinary tract dysfunction was searched. Based on the information available in the literature and also based on personal experience, the urological indications, technique, mechanisms of action and results of SNM are presented and discussed.

Results

SNM for lower urinary tract dysfunction involves stimulation of the 3rd sacral nerve with an electrode implanted in the sacral foramen and connected to a pulse generator. The technique is accepted by the FDA since 1997. Currently, SNM for lower urinary tract dysfunction has been successfully used in about 26,000 patients with various forms of lower urinary tract dysfunction, including urgency, frequency and urgency incontinence as well as non-obstructive urinary retention. The actual procedure of SNM consists of a minimal invasive technique and is effective in about 70% of the patients who have been implanted with a permanent system. Also, in pelvic pain, interesting results have been described. SNM modulates the micturition reflexes at different levels in the central nervous system.

Conclusions

Sacral neuromodulation is a safe and effective therapy for various forms of lower urinary tract dysfunction, including urgency, frequency and urgency incontinence as well as non-obstructive urinary retention. It should be the first choice after failure of maximal conservative therapy.     

Sacral neuromodulation for constipation and fecal incontinence in children

Sacral neuromodulation has become an established treatment option for adults with fecal incontinence, but has only been applied to children with defecatory disorders over the past decade. Unlike in adults, the primary cause of fecal incontinence in children is poorly controlled constipation. There is growing evidence that sacral neuromodulation can be effective in the treatment of children with both constipation and fecal incontinence refractory to conventional treatment, and sacral nerve stimulation appears to be a promising treatment for a population of children with limited treatment options and debilitating symptoms. However, both experience with this treatment modality and the quality of evidence for its use remain limited. Given the relatively high complication rate associated with sacral nerve stimulation, further research is needed before more widespread acceptance of this treatment in the management of children with refractory constipation and fecal incontinence.     

Sacral nerve stimulation for neuromodulation of the lower urinary tract

Patients with symptoms of overactive bladder syndrome or non-obstructive urinary retention, refractory to conservative therapy, can nowadays be treated minimally invasively with sacral nerve stimulation (SNS). The use of electric currents to treat urological pathology has a long history but SNS therapy only received FDA approval in 1997. The mechanisms of action are still not known so there are different theories explaining the modulation effect. Recent studies have shown a central modulation effect. Predictive factors which can help to identify the perfect candidates are not known. Over the years the technique of SNS has become less invasive and because of two stage implantation test results have proven to be more reliable. The clinical results for this therapy have proven to be safe and effective and with the technical improvements over the years the re-operation and complication rates have decreased significantly. The clinical results have led to expanding indications because of positive effects in other symptoms. In the field of urology this has resulted in the use of SNS therapy for interstitial cystitis, neurogenic lower urinary dysfunction, and pediatric voiding dysfunction. In the field of gastro-intestinal pathology, SNS therapy is used to treat faecal incontinence and constipation.     

Sacral neuromodulation for the treatment of bladder dysfunction

S3 nerve root neuromodulation is becoming an accepted therapy for individuals afflicted with lower urinary tract symptoms, such as idiopathic urinary urge incontinence, frequency, urgency, and urinary retention, who fail current standard therapies. This patient population is difficult to treat, and this therapy offers an option that can restore quality of life to these individuals. While the precise pathophysiologic mechanisms underlying these voiding symptoms is unknown based on the physiology of bladder function, it is logical to conclude that they relate to some aberration of the neuromuscular apparatus of the bladder and/or its outlet (the urethra). These pathophysiologic defects are not overtly manifested outside the lower urinary tract because these patients routinely do not have any apparent neurologic deficits. The fact that S3 neuromodulation can clinically improve these lower urinary tract symptoms would support the notion that the neural regulation of the bladder is somehow altered in these patients. This paper presents a review of the current knowledge regarding sacral neuromodulation in treatment of non-neurogenic voiding dysfunction.     

Sacral neuromodulation for urinary retention after pelvic plexus injury

Injury to the pelvic plexus with resultant urinary retention is a known complication of colectomy. We describe a case of urinary retention after colectomy successfully treated with the insertion of a pelvic neuromodulator.     

Sacral neuromodulation for urinary retention in a kidney-transplant patient

Bladder outlet obstruction can negatively affect renal function in the kidney transplant population. Functional obstruction represents a clinical challenge as conventional treatments are either ineffective or not recommended. Sacral neuromodulation was successfully used in functional voiding dysfunction in a kidney transplant patient. This is the first case to be reported in the literature.     

Sacral neuromodulation: an effective treatment for lower urinary tract symptoms in multiple sclerosis

Introduction and hypothesis

Most subjects with multiple sclerosis (MS) suffer from lower urinary tract symptoms (LUTS). Detrusor overactivity, detrusor hypocontractility and detrusor–sphincter dyssynergia are the most common bladder dysfunctions. Management is not straightforward due to the progressive course of the disease. Sacral neuromodulation (SNM) has received increasing attention among new effective treatments for bladder disorders associated with MS. The aim of this study was to review the published literature on the role of SNM in the treatment of LUTS in patients with MS.

Methods

A literature search was carried out up to December 2014, using relevant search terms in MEDLINE and EMBASE databases. The ClinicalTrials.gov and Controlled-trials.com online trial registries and the abstracts from international scientific meetings were searched for English-language studies containing relevant search terms. Relevant reviews and trials and prospective studies were analysed by two independent reviewers.

Results

Two prospective studies and four retrospective studies were included. Overall, MS patients represented small series (4 to 25 subjects). The longest follow-up was 7 years and the evaluation of the treatment outcomes was not homogeneous among the studies. The definition of objective cure was often unclear. The subjective cure rate was 45 %, patients’ reported satisfaction was 85 % and all the results were stable over time.

Conclusions

SNM seems to be a safe and effective treatment for LUTS in MS patients. Further and larger studies as well as randomized controlled trials are needed to confirm its clinical role in patients with MS.

     

Urodynamic evaluation of sacral neuromodulation for urge urinary incontinence

OBJECTIVE

To evaluate the urodynamic data before and 6 months after implantation of sacral neuromodulation (SNM, an established treatment for voiding dysfunction, including refractory urge urinary incontinence, UI) and to assess the correlation between the urodynamic data and clinical efficacy in patients with UI.

PATIENTS AND METHODS

In all, 111 patients with a >50% reduction in UI symptoms during a percutaneous nerve evaluation test qualified for surgical implantation of SNM. Patients were categorized in two subgroups, i.e. those with UI with or without confirmed detrusor overactivity (DO) at baseline. At the 6‐month follow‐up all patients had a second urodynamic investigation, with the stimulator switched on.

RESULTS

At baseline, there was urodynamically confirmed DO in 67 patients, while 44 showed no DO. A review of filling cystometry variables showed a statistically significant improvement in bladder volumes at first sensation of filling (FSF) and at maximum fill volume (MFV) before voiding for both UI subgroups, compared with baseline. In 51% of the patients with UI and DO at baseline, the DO resolved during the follow‐up. However, those patients were no more clinically successful than those who still had DO (P = 0.73). At the 6‐month follow‐up, 55 of 84 implanted patients showed clinical benefit, having a ≥50% improvement in primary voiding diary variables. Patients with UI but no DO had a higher rate of clinical success (73%) than patients with UI and DO (61%), but the difference was not statistically significant.

CONCLUSION

These urodynamic results show a statistically significant improvement in FSF and MFV in patients with UI with or with no DO after SNM. Although there was a urodynamic and clinical improvement in both groups, patients with UI but no DO are at least as successful as patients with UI and DO. Therefore in patients with UI, DO should not be a prerequisite selection criterion for using SNM.     

骶神经调节术治疗顽固性便秘疗效观察

目的：观察骶神经调节术（SNM）治疗顽固性便秘的临床效果。方法第四军医大学西京消化病医院消化外科于2013年1月至2014年1月期间,采用骶神经调节测试系统经皮穿刺,刺激第3骶神经根,治疗7例复杂便秘患者,其中4例患者既往进行过至少1次的便秘手术。通过排粪日记、Cleveland便秘评分及视觉模拟评分（VAS）进行疗效评价。结果7例患者在接受体外临时测试治疗后,便秘症状均明显改善。其中6例接受永久性骶神经调节器植入术,围手术期未见并发症。术后随访中位时间4（2～12）月,6例患者的每周排粪次数由治疗前（0．6±0．5）次／周,增加到（8．0±2．5）次／周（P＜0．01）;排粪时间从（22．9±11．5） min减少到（3．7±0．8） min（P＜0．01）;Cleveland便秘评分从（24．6±4．2）分下降到（9．0±0．9）分（P＜0．01）;VAS评分从（8．1±0．9）分增加到（82．5±5．2）分（P＜0．01）。结论 SNM是治疗顽固性便秘的一种微创而安全有效的新方法。