A Supervised 3 Weeks Test Phase in Sacral Neuromodulation with a 1-Year Followup.

PURPOSE: We sought to determine whether prolonged interventional test phase increases cumulative success rate and compared success rates between early responders (ie within 1 week) and those in need for reprogramming (due to lack of efficacy) of sacral neuromodulation after 1-year followup. MATERIALS AND METHODS: In a single tertiary center prospective study (August 2015 to November 2018) 90 patients refractory to first line treatment were eligible for sacral neuromodulation, including 48 overactive bladder wet (53%), 8 overactive bladder dry (9%) and 34 nonobstructive urinary retention (38%). Patients were evaluated at weekly intervals during test phase and those not successful were reprogrammed. This could be repeated after the second week. Primary outcome was success rate after 3-week test phase and after 1-year followup. Statistical analysis was done by nonparametric tests for numeric (Mann-Whitney U) and categorical (chi2) data. RESULTS: After 3 weeks of test period 56 patients (62%) were considered successful. Prolonged interventional testing increased cumulative success. A 1-year followup showed no significant difference in success rate between early responders and those in need for reprogramming (chi2, p=0.562). There was no difference in age (Mann-Whitney U, p=0.222), sex (chi2, p=0.952) or indication (chi2, p= 0.975). CONCLUSIONS: A 3-week test phase with close followup increases cumulative success rate. During this supervised 3-week test phase 42% of the initial nonresponders after the first week became successful candidates after reprogramming. Patients who required this additional programming did equally as well as those without need for reprogramming. A supervised 3-week test phase is therefore strongly recommended.

Long-term outcomes of sacral neuromodulation for lower urinary tract dysfunction: A 23-year experience.

AIMS: To evaluate the long-term outcomes of sacral neuromodulation (SNM), and patient characteristics that may predict long-term success or complications. METHODS: A single-center retrospective cohort study was performed of all patients who underwent SNM testing and implantation. Outcome results, resolution of symptoms, and device removal were reported. Multivariable logistic regression was used to identify predictors of success. Cox proportional hazards model was used to identify predictors for device removal. RESULTS: Four hundred and thrity four patients underwent SNM test phase of which 241 (median age 48.0 years, 91.7% [221/241] female) had device implantation and were followed up for median [range] time of 4.0 (3 months-20.5 years) years. Multivariable logistic regression showed that male gender (odds ratio: 0.314; 95% confidence interval: 0.164-0.601, p = .0005) was independently associated with decreased peripheral nerve evaluation success. At final follow-up for patients who originally had device implantation, median (interquartile range) percent of symptoms resolution of all patients was 60.0% (0%-90%) and 69.3% (167/241) had SNM successful outcomes. Cox proportional hazards model showed no difference for time to SNM device removal with respect to patient age, gender, or diagnosis. 69.3% (167/241) patients had at least 1 surgical re-intervention. The most common reason at first surgical re-intervention was lead change only (26.3%, 44/167). CONCLUSION: SNM is a minimally invasive procedure with good long-term success rates. There is a high revision rate but overall, SNM has a good safety profile and excellent long-term outcomes.

Neural pathway of bellows response during SNM treatment revisited: Conclusive evidence for direct efferent motor response.

BACKGROUND: In sacral neuromodulation (SNM) patients, it is thought the bellows response elicited upon sacral spinal nerve stimulation is reflex-mediated. Therefore the mechanism of action of SNM is considered to be at the spinal or supraspinal level. These ideas need to be challenged. OBJECTIVE: To identify the neural pathway of the bellows response upon sacral spinal nerve stimulation. DESIGN, SETTING, AND PARTICIPANTS: Single tertiary center, prospective study (December 2017-June 2019) including 29 patients with overactive bladder refractory to first-line treatment. INTERVENTION: Recording of the pelvic floor muscle response (PFMR) using a camcorder and electromyography (EMG) (intravaginal probe and concentric needles) upon increasing stimulation during lead or implantable pulse generator placement. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The lowest stimulation intensity needed to elicit a visual PFMR and electrical PFMR was determined. Electrical PFMRs were subdivided according to their latency. OUTCOME: the association between visual and electrical PFMRs. Statistical analyses were performed using the weighted kappa coefficient. RESULTS: Three different electrical PFMRs could be identified by surface and needle EMG, corresponding with a direct efferent motor response (R1), oligosynaptic (R2), and polysynaptic (R3) afferent reflex response. Only the R1 electrical PFMR was perfectly associated with the visual PFMR (κ = 0.900). CONCLUSIONS: The visual PFMRs upon sacral spinal nerve stimulation are direct efferent motor responses. A reopening of the discussion on the mechanism of action of SNM is possibly justified.

Refractory overactive bladder patients who chose sacral neuromodulation therapy after failed OnabotulinumtoxinA treatment: A systematic review and meta-analysis.

OBJECTIVE: To systematically review outcomes in patients with refractory overactive bladder (OAB) patients who underwent sacral neuromodulation therapy (SNM) therapy after unsuccessful onabotulinumtoxinA (BTX) therapy, and to compare outcomes with those who SNM as initial therapy. METHODS: A systematic search of Cochrane Library, Pubmed and Embase databases from July 2002 to November 2019, to analyze randomized controlled trials and retrospective studies of SNM therapy after failed initial BTX therapy. Two reviewers independently screened the studies and extracted data. A quality assessment of the included literature was conducted using Newcastle-Ottawa Scale (NOS), and Stata 12.0 software was used to conduct a meta-analysis of the collected data. RESULTS: A total of seven studies involving 319 patients were finally included. The success rate in refractory OAB patients who used SNM therapy after failed BTX therapy was 58.5%, 95% CI (0.47-0.70). There was no significant difference between refractory OAB patients who chose SNM as replacement therapy after failed BTX therapy and those who used SNM therapy as first choice [RR = 0.96, 95%CI (0.72-1.26), P = 0.735]. CONCLUSION: OAB patients for whom an initial choice of BTX therapy ends in failure or dissatisfaction may consider switching to SNM therapy. There is no difference in outcomes between these patients and those whose first choice was SNM therapy.

Rehabilitation strategies for low anterior resection syndrome. A systematic review.

OBJECTIVE: To summarize the evidence in the literature about rehabilitative treatments that reduce low anterior resection syndrome (LARS) symptoms in patients who underwent surgery for colorectal cancer. METHODS: We have search in PubMed, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health and Scopus databases. Studies selected were limited to those including only patient undergone low rectal resection with sphincter preservation and with pre-post assessment with a LARS score. Five articles fit the criteria. RESULTS: The percutaneous tibial nerve stimulation demonstrated moderate results and sacral nerve stimulation was found to be the best treatment with greater symptom improvement. Only one study considered sexual and urinary problems in the outcomes assessment. CONCLUSIONS: In clinical practice patients should evaluate with the LARS and other score for evaluation of urinary and sexual problems. Future research must be implemented with higher quality studies to identify the least invasive and most effective treatment/s.

Comparing the Efficacy of OnabotulinumtoxinA, Sacral Neuromodulation, and Peripheral Tibial Nerve Stimulation as Third Line Treatment for the Management of Overactive Bladder Symptoms in Adults: Systematic Review and Network Meta-Analysis.

The American Urological Association guidelines for the management of non-neurogenic overactive bladder (OAB) recommend the use of OnabotulinumtoxinA, sacral neuromodulation (SNM), and peripheral tibial nerve stimulation (PTNS) as third line treatment options with no treatment hierarchy. The current study used network meta-analysis to compare the efficacy of these three modalities for managing adult OAB syndrome. We performed systematic literature searches of several databases from January 1995 to September 2019 with language restricted to English. All randomized control trials that compared any dose of OnabotulinumtoxinA, SNM, and PTNS with each other or a placebo for the management of adult OAB were included in the study. Overall, 17 randomized control trials, with a follow up of 3-6 months in the predominance of trials (range 1.5-24 months), were included for analysis. For each trial outcome, the results were reported as an average number of episodes of the outcome at baseline. Compared with the placebo, all three treatments were more efficacious for the selected outcome parameters. OnabotulinumtoxinA resulted in a higher number of complications, including urinary tract infection and urine retention. Compared with OnabotulinumtoxinA and PTNS, SNM resulted in the greatest reduction in urinary incontinence episodes and voiding frequency. However, comparison of their long-term efficacy was lacking. Further studies on the long-term effectiveness of the three treatment options, with standardized questionnaires and parameters are warranted.

[Sacral neuromodulation in under- and overactive detrusor-quo vadis? : Principles and developments]. / Sakrale Neuromodulation bei unter- und überaktivem Detrusor ­ quo vadis? : Prinzipien und Entwicklungen.

BACKGROUND: Sacral neuromodulation (SNM) has been used in the treatment of refractory overactive bladder syndrome, nonobstructive urinary retention and faecal incontinence for almost 40 years now. It is not to be confused with the sacral anterior root stimulation which is exclusively used for bladder dysfunction due to spinal paraplegia. MECHANISM OF ACTION: The principles of SNM are yet to be fully understood. Nevertheless, there is proof of modulating the activity of several micturition-associated, afferent neurons in the spine, brainstem and cerebrum. Thus, premature detrusor contractions are suppressed, the desire to void is delayed and detrusor-sphincter coordination improves. TECHNIQUES OF IMPLANTATION AND STIMULATION: Motor reactions are an important indicator of correct electrode placement. The implantation procedure consists of two stages with an initial trial phase to determine the best possible treatment response through an external generator before implanting the whole stimulating device. Yearly check-up examinations are recommended; wireless adjustments allow for long-lasting symptom reduction. INDICATION AND OUTCOME: Success rates in the treatment of the refractory overactive bladder syndrome and the non-obstructive urinary retention lie above 70% and can still be perceived as sufficient after 5 years of ongoing SNM therapy. There is also profound evidence of SNM being an effective option for patients with faecal incontinence or chronic obstipation. CONTRAINDICATIONS AND RISKS: Children, pregnant women and patients in need of frequent MRI examinations are usually not eligible for SNM therapy. Infection of the implant, technical failure (including lead displacement and battery depletion) and pain in the implantation site are important adverse effects which might require surgical revision. CONCLUSIONS: The indications for SNM in the German health care system can be expected to be expanded upon the chronic pelvic pain syndrome, erectile dysfunction and additional gastrointestinal conditions. Technical progress will continue to improve the risk-benefit ratio of SNM.

First-in-human implantation of a mid-field powered neurostimulator at the sacral nerve: Results from an acute study.

INTRODUCTION: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. MATERIALS AND METHODS: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. RESULTS: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. CONCLUSIONS: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.

Repeatability of tools to assist in the follow up and troubleshooting of sacral neuromodulation patients using the sensory response.

PURPOSE: Sacral neuromodulation (SNM) is an established minimally invasive therapy for functional disorders of the pelvic organs in which electrodes are stimulated in proximity of the sacral spinal nerves. Reprogramming of the electrodes is regularly required and is based on the sensory response. This study assesses the repeatability of a pelvic chart and grading system to enable a more objective assessment of the sensory response upon electrode stimulation. MATERIAL AND METHODS: In 26 SNM patients, with OAB or NOUR, assessment of the sensory response was done using the sensory threshold (ST) and a pelvic chart with 1 cm2 coordinates, each coordinate corresponding with a dermatome and location of sensation (LoS). A grading system was developed based upon the ST and LoS. Repeatability of ST was assessed using a two-way mixed effects, absolute agreement, single rater/measurement intraclass correlation coefficient (ICC), and displayed using a correlation and Bland Altman plot. Repeatability of dermatomes, LoS, and grading system was assessed using kappa correlation coefficient. RESULTS: On average, 1.55 ± 0.85 coordinates were used to point out the area where the stimulation was perceived. The mean amount of coordinates between the area pointed at during the first and second measurement was 0.47 ± 0.74. ST showed excellent repeatability (ICC 0.93, 95%CI 0.90-0.94, P < 0.001). Dermatomes, LoS and grading system showed a substantial to almost perfect agreement (κ = 0.740-0.833, P < 0.001). CONCLUSIONS: The pelvic chart and grading system, using the sensory response upon electrode stimulation, are repeatable tools and can be used to assist in follow up and troubleshooting of SNM patients.

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.

AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.

[Sacral neuromodulation: Indications and technical aspects]. / Neuromodulation des racines sacrées : indications et modalités thérapeutiques.

Sacral neuromodulation is a second line therapy, especially indicated in overactive bladder. The initial assessment includes a complete clinical examination with a frequency-volume chart. The cystoscopy and urodynamics are optional. There are two steps in the implantation of a sacral neuromodulation: first, the implantation of the electrode to test if the device is efficient and corrects the urinary disorder. Two, the implantation of the neuromodulation itself. During the follow-up, the role of the nurse is crucial in explaining to the patients how the device works. Post-operative follow-up is based on the frequency-volume chart and the feeling of the patient's back. It also includes the surveillance of the postoperative scares.

Women Undergoing Third Line Overactive Bladder Treatment Demonstrate Elevated Thermal Temporal Summation.

PURPOSE: We sought to determine whether women with overactive bladder who required third line therapy would demonstrate greater central sensitization, indexed by temporal summation to heat pain stimuli, than those with overactive bladder. MATERIALS AND METHODS: We recruited 39 women with overactive bladder from the urology clinic who were planning to undergo interventional therapy for medication refractory overactive bladder with onabotulinumtoxinA bladder injection or sacral neuromodulation. We also recruited 55 women with overactive bladder who were newly seen at our urology clinic or who responded to advertisements for study participation. Participants underwent quantitative sensory testing using a thermal temporal summation protocol. The primary study outcome was the degree of temporal summation as reflected in the magnitude of positive slope of the line fit to the series of 10 stimuli at a 49C target temperature. We compared the degree of temporal summation between the study groups using linear regression. RESULTS: Women in the group undergoing third line therapy showed significantly higher standardized temporal summation slopes than those in the nontreatment group (ß = 1.57, 95% CI 0.18-2.96, t = 2.25, p = 0.027). On exploratory analyses a history of incontinence surgery or hysterectomy was associated with significantly greater temporal summation. CONCLUSIONS: In this study the degree of temporal summation was elevated in women undergoing third line overactive bladder therapy compared to women with overactive bladder who were not undergoing that therapy. These findings suggest there may be pathophysiological differences, specifically in afferent nerve function and processing, in some women with overactive bladder.

Improving clinical outcomes for women with overactive bladder or urinary retention symptoms: a comparison of motor response voltages (1-9 V) during Stage 1 sacral neuromodulation.

OBJECTIVE: To assess whether the utilisation of a motor response of <3 V during Stage 1 sacral neuromodulation (SNM) results in better clinical outcomes compared to >4 V in patients with overactive bladder (OAB) or urinary retention symptoms. PATIENTS AND METHODS: An observational, retrospective, double cohort review was conducted of 339 female patients who had experienced medically recalcitrant OAB or urinary retention symptoms. Between September 2001 and September 2014, both cohorts underwent successful Stage 1 to Stage 2 SNM placement. Group A, included 174 women with a motor response at ≤3 V; and Group B, evaluated 110 women with a motor response at ≥4 V for medically recalcitrant OAB. Group C, compared 33 women with a motor response at ≤3 V; and Group D, documented 22 women with a motor response at ≥4 V for non-obstructive urinary retention. Patients completed 3-day voiding diaries, the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Patient Global Impression of Improvement Questionnaire. RESULTS: The mean (sd) follow-up was 116.3 (30.3) months in Group A and 112 (34.6) months in Group B (P < 0.354); 150.5 (20.4) months in Group C and 145.8 (17.2) months in Group D (P < 0.38). Successful conversion of Stage 1 to Stage 2 showed statistically significant improvement for both <3-V groups (Groups A and C). Group A had a 93.5% (174/186) conversion rate vs 72.3% (110/152) in Group B for OAB symptoms (P < 0.001). Group C had a 94% (34/36) conversion rate vs 70% (21/30) in Group D (P < 0.017). Defined as a ≥50% reduction in frequency, urgency, urgency incontinence and nocturia, and UDI-6 and IIQ-7 scores, the success rate for Group A was 82.1% (143/174) and for Group B was 63% (69/110) (P < 0.001). The mean battery life improved in both <3-V cohorts (P < 0.001). Annual reprogramming sessions were reduced in Group A and Group C (P < 0.001). Subset analysis of variance showed no statistical improvement in most patient outcomes when 1-V subjects were compared to 2- and 3-V cohorts. However, 32% of 1-V patients (P < 0.001) noted the onset of severe pelvic/perirectal pain and big toe plantar flexion movement with small increments in voltage (0.1-0.2 V) during reprogramming. Only 7% of 2-V and 1% of 3-V patients experienced this complication. CONCLUSIONS: Significant improvement was noted (up to 40%) in most clinical voiding parameters in the <3-V patients for both OAB and urinary retention. While <3 V will still statistically improve patient outcomes, a voltage <2 V may elicit self-reprogramming pain with severe bellows and plantar flexion movement, which may discourage patients from therapy adjustments. We recommend randomised, controlled trials to confirm these results.

Specific Changes in Brain Activity during Urgency in Women with Overactive Bladder after Successful Sacral Neuromodulation: A Functional Magnetic Resonance Imaging Study.

PURPOSE: The mechanism of sacral neuromodulation is poorly understood. We compared brain activity during urgency before and after sacral neuromodulation in women with overactive bladder and according to the response to treatment. MATERIALS AND METHODS: Women with refractory overactive bladder who elected sacral neuromodulation were invited to undergo functional magnetic resonance imaging before and after treatment. During imaging the bladder was filled until urgency was experienced. Regions of interest were identified a priori and brain activity in these regions of interest was compared before and after treatment as well as according to the treatment response. Whole brain exploratory analysis with an uncorrected voxel level threshold of p <0.001 was also performed to identify additional brain regions which changed after sacral neuromodulation. RESULTS: Of the 12 women who underwent a pretreatment functional magnetic resonance imaging examination 7 were successfully treated with sacral neuromodulation and underwent a posttreatment examination. After sacral neuromodulation brain activity decreased in the left anterior cingulate cortex, the bilateral insula, the left dorsolateral prefrontal cortex and the bilateral orbitofrontal cortex (each p <0.05). No new brain regions showed increased activity after sacral neuromodulation. Pretreatment brain activity levels in the bilateral anterior cingulate cortex, the right insula, the bilateral dorsolateral prefrontal cortex, the right orbitofrontal cortex, the right supplementary motor area and the right sensorimotor cortex were higher in women who underwent successful treatment (each p <0.05). CONCLUSIONS: Brain activity during urgency changes after successful sacral neuromodulation. Sacral neuromodulation may be more effective in women with higher levels of pretreatment brain activity during urgency.

Effectiveness of sacral nerve stimulation in fecal incontinence after multimodal oncologic treatment for pelvic malignancies: a multicenter study with 2-year follow-up.

BACKGROUND: To assess whether sacral nerve stimulation (SNS) is an effective treatment for severe fecal incontinence (FI) after radiotherapy (RT)/chemoRT (CRT) in combination with pelvic surgery. METHODS: A multicenter study was conducted on patients with FI that developed after multimodal therapy for pelvic tumors and was refractory to non-operative management, who were treated with SNS between November 2009 and November 2012. Data were prospectively collected and retrospectively analyzed. Cleveland Clinic FI score (CCFIS), FI episodes per week, FI Quality of Life (FIQoL), anorectal manometry and pudendal nerve terminal motor latency were evaluated before and after SNS. RESULTS: Eleven patients (seven females, mean age 67.3 ± 4.8 years) were evaluated in the study period. Multimodal treatments included surgery and CRT (four rectal, two cervical and one prostate cancers), surgery and RT (one cervical and two endometrial cancers) and CRT (one anal cancer). The mean radiation dose was 5.3 Gy, and mean interval between the end of RT and onset of FI was 43.7 ± 23 months. Before SNS, the mean CCFIS and the mean number of FI episodes per week were 15.7 ± 2.8 and 12.3 ± 4.2, respectively. At 12-month follow-up, mean CCFIS improved to 3.6 ± 1.8 (p = 0.003) and the mean number of FI episodes decreased to 2.0 ± 1.9 per week (p = 0.003). These results persisted at 24-month follow-up. Significant improvement was also observed for each of the four domains of FIQoL at 12- and 24-month follow-up. Anorectal manometry values did not change significantly at follow-up. CONCLUSIONS: SNS is feasible and may be an effective therapeutic option for FI after multimodal treatment of pelvic malignancies.

Onset of Action of Sacral Neuromodulation in Lower Urinary Tract Dysfunction-What is the Optimal Duration of Test Stimulation?

PURPOSE: Since the development of sacral neuromodulation, a large number of patients with lower urinary tract symptoms have been treated with this procedure. A test stimulation is performed prior to implantation. At centers worldwide the duration of this test stimulation varies considerably since it is not certain when the onset of the therapy effect can be expected. The objective of this prospective study was to evaluate the average onset time of sacral neuromodulation in patients with lower urinary tract symptoms. MATERIALS AND METHODS: All patients who were eligible for treatment with sacral neuromodulation were asked to participate in this study. A voiding diary was filled out prior to and during test stimulation using an implanted tined lead. Success was defined as a 50% or greater improvement compared to baseline in any of the main complaint parameters. The Mann-Whitney U test was used to compare the mean time to success between patients with overactive bladder syndrome and patients with nonobstructive urinary retention. RESULTS: Of the 45 patients 24 with nonobstructive urinary retention and 21 with overactive bladder syndrome agreed to participate and were included in study. Test stimulation was successful in 29 patients (64%). Mean time to success in all patients was 3.3 days (range 1 to 9). There was no significant difference in mean time to success between cases of overactive bladder syndrome and nonobstructive urinary retention (3.25 and 3.5 days, respectively, p = 0.76). CONCLUSIONS: The results imply that a test stimulation of more than 2 weeks is not necessary if a cutoff of 50% or greater improvement is adopted. However, further improvement can be expected with prolonged test stimulation. This might be important since it might have implications for long-term results.

Role of sacral neuromodulation in modern urogynaecology practice: a review of recent literature.

Sacral neuromodulation (SNM) offers promise in the therapy of many pelvic floor disorders. This innovative treatment has slowly gained popularity. A review of recent literature is presented in relation to its efficacy and complications in various pelvic floor conditions: overactive bladder and urge urinary incontinence, chronic urinary retention, painful bladder syndrome, pelvic pain and double incontinence. It is a minimally invasive, completely reversible safe procedure with good long-term outcomes. However, the treatment is costly, the revision rate is high and patients require life-long follow-up. SNM should always be considered in suitable patients before offering bladder augmentation procedures or urinary diversion or permanent catheterization for bladder dysfunction. SNM should also be considered in patients with double incontinence, after discussion in a urogynaecology/colorectal multidisciplinary team.

Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation.

PURPOSE: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. MATERIALS AND METHODS: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. RESULTS: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60-74) using modified completers analysis and 82% (95% CI 76-88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). CONCLUSIONS: This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.

Long-Term Functional Outcomes of S3 Sacral Neuromodulation for the Treatment of Idiopathic Overactive Bladder.

OBJECTIVES: To assess the long-term functional outcomes of sacral neuromodulation (SNM) in the treatment of refractory idiopathic overactive bladder (IOAB) and to determine predictive factors for success. MATERIALS AND METHODS: To obtain long-term data, all consecutive patients suffering from IOAB and treated by SNM at a single tertiary care center between December 1996 and December 2004 were included. Data regarding patient demographics, past medical, and surgical history, bladder diary, complications as well as device revision and removal rates were collected. Success was defined as an improvement ≥ 50% of any clinical parameter. RESULTS: Overall, 34 patients, with a median age of 57.8 years (IQR 44.8-65.7) were included. Immediately after definitive implantation, 2 (6%) patients were lost to follow-up. After a median follow-up of 9.7 years (IQR 4.7-12.0), SNM was considered successful in 20 (63%) patients. Mean amount of protections used per 24 hours significantly decreased (4.1 preoperatively vs. 1.8 at the last follow-up visit, p = 0.02). Devices were removed in 2 (6%) patients due to pain and lack of efficacy. Twenty-two revision surgeries were performed in 15 (47%) patients. First revision surgery occurred after a mean of 6.2 years (± 3.1). Revision surgeries were mainly performed for end of battery life/device dysfunction (n = 18, 82%). No significant predictor for success was identified. CONCLUSIONS: With a median follow-up time of 9.7 years, this retrospective SNM study reports a 63% efficacy rate (≥ 50% improvement) for the treatment of refractory IOAB. Moreover, it is a well-tolerated and minimally invasive therapy.