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BJUI Mini Reviews - Sacral Neuromodulation for Treating the Symptoms of Overactive Bladder Syndrome and Non-Obstructive Urinary Retention: More Than 10 Years of Clinical Experience Show Comments PDF Print E-mail
  
Tuesday, 11 March 2008
BJUI Mini Reviews - SNM has emerged as a valuable minimally invasive treatment option for patients with lower urinary tract dysfunctions such as OAB and nonobstructive UR in whom conservative treatments have failed.

Sacral neuromodulation for treating the symptoms of overactive bladder syndrome and non-obstructive urinary retention: > 10 years of clinical experience Emmanuel Chartier-Kastler Faculté Pierre et Marie Curie, Université Paris VI, Hospital Pitié-Salpêtrière, Assistance Publique Hôpitaux de Paris, France Accepted for publication 13 July 2007 KEYWORDS efficacy, overactive bladder, quality of life, randomized controlled trials, sacral neuromodulation, safety, urinary retention INTRODUCTION Overactive bladder (OAB) syndrome is a common condition affecting millions of people in the Western world. It is typically associated with urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia [1]. The International Consultation on Incontinence (ICI), and other international guidelines, currently recommend diet and lifestyle modifications and behavioural therapy (e.g. pelvic floor muscle training, bladder retraining or biofeedback) in combination with antimuscarinic therapy as first-line treatment for patients with OAB [2]. However, in many patients conservative therapy does not sufficiently alleviate the symptoms of OAB. A study conducted in 2002 in 21 362 patients showed that at 1 year after the first prescription, only 15% of patients remained on OAB medication (Fig. 1) [3]. In most cases, patients stop taking medication because of lack of efficacy or side-effects. A survey among 1447 people receiving treatment for UI showed that younger patients ( < 50 years old) are twice as likely to stop using antimuscarinic agents as are older patients [4]. Up to a few years ago the only alternative therapies for these patients were invasive and irreversible surgical procedures, e.g. augmentation cystoplasty and urinary diversion. These procedures are associated with significant short- and long-term risk and morbidity, and in many cases the treatment becomes more bothersome than the condition itself. Therefore, surgery (as bladder enlargement) should be considered as a last resort when all other treatment options have failed. The same problems apply to urinary retention (UR), for which immediate treatment usually consists of intermittent catheterization [5]. Until recently, the only second-line treatment for patients with UR was surgery, which is associated with significant morbidity. If not treated, UR can have serious health consequences, e.g. reflux, upper urinary tract damage, infection and overflow UI. As previous reports showed an acute effect of afferent stimulation in modulating detrusor overactivity [6], neuromodulation (NM), and particularly sacral NM (SNM) has emerged as a valuable minimally invasive treatment option for patients with lower urinary tract dysfunctions such as OAB and nonobstructive UR in whom conservative treatments have failed. SNM SNM involves continuous electrical stimulation of the sacral nerves to inhibit or activate the neural reflexes that influence the bladder, sphincter and pelvic floor. Basically, a pacemaker-like implantable neurostimulator (INS) sends mild electrical pulses to electrodes that are usually placed next to the third sacral nerve (S3). Since its first description by Schmidt et al. in 1979 [7], SNM has developed from an elaborate procedure to a minimally invasive technique that can be easily done under local anaesthesia in an outpatient setting. Unlike surgery, SNM is a reversible technique that does not preclude other treatment options. In the most recent 2004 ICI guidelines, SNM was proposed as an option for patients with UUI to be considered when conservative therapy fails [2]. SNM with the InterStim TM device (Medtronic, Inc., Minneapolis, MI, USA) was CE-marked in Europe in 1994 and approved by the Food and Drug Administration (FDA) for treating refractory UUI in October 1997, and for idiopathic UR and symptoms of urgencyfrequency in 1999. Over the past decade, InterStim therapy has gained global acceptance in urological practice and > 35 000 patients have been treated worldwide. MODE OF ACTION OF SNM In adults, certain brain pathways are critical for controlling the sphincter and urethral guarding reflexes to allow micturition. When these brain mechanisms are damaged by spinal cord injury, this can lead to inefficient bladder emptying. Dysfunctional voiding can C H A R T I E R - K A S T L E R © 2 0 07 T H E A U T H O R 41 8 J O U R N A L C O M P I L A T I O N © 2 0 07 B J U I N T E R N A T I O N A L also occur after more subtle lesions, as a result of prostatitis or urinary tract infection (UTI), or it might be idiopathic. Although the exact mechanism of action of SNM in patients with bladder dysfunction remains unclear, it is thought to restore normal voiding by affecting different levels of the nervous system [8]. In patients with OAB, SNM would restore the balance between inhibitory and excitatory control systems at various sites in the peripheral and CNS. This would involve activation of somatosensory bladder afferents projecting into the pontine micturition centre in the brainstem, and/or activation of the hypogastric sympathetic nerves [9]. In patients with non-obstructive UR, SNM probably stimulates voiding through a combination of different mechanisms involving the neuroaxis at different levels. It was suggested that SNM exerts its therapeutic effects in these patients by restoring activity associated with brainstem and attenuating cingulated activity [10]. A positron emission tomography study recently showed that in newly implanted patients, SNM affects cerebral blood flow predominantly in brain areas involved in sensori-motor learning, while brain areas involved in micturition and in awareness and alertness are affected in chronically implanted patients. This suggests a shift from dysfunctional to electrical restoration of normal control of detrusor activity [11]. TEST AND IMPLANTATION PROCEDURES OF SNM The implantation of SNM consists of two phases: the test phase, i.e. temporary stimulation (Fig. 2a) of the sacral nerves predominantly in S3, for 1–4 weeks with a temporary or permanent implanted lead; and a permanent phase, i.e. implantation of the INS (Fig. 2b). The test phase is used to select those patients who are eligible for permanent implantation, and consists of an acute stimulation period, to test neural integrity and correct placement of the lead, and a chronic stimulation period, with home evaluation. The SNM test procedure has undergone a major development in the last few years. The traditional test procedure, the percutaneous nerve evaluation (PNE) test, involves positioning a temporary lead in the S3 foramen with the patient under local anaesthesia. Patients are tested with the temporary lead for 4–14 days; those with ≥ 50% symptom improvement usually have a permanent lead and INS implanted. Although PNE is a valuable test procedure to select patients eligible for permanent implantation, the temporary lead is prone to migration during the subchronic test phase. Consequently, some patients who do not have successful stimulation during PNE can nevertheless have a satisfactory response after permanent implantation. In addition, the PNE test procedure is usually limited to ≈ 1 week because of the risk of infection. To address these issues, several modifications and improvements of the classical test procedure were proposed over the last few years. By using a staged implant procedure, in which a permanent lead is used during the test phase, response rates could be considerably improved. The staged implant procedure offers the advantage of a prolonged test period and more reliable patient selection, with fewer false-negative results due to lead migration, than traditional PNE. Only a minor surgical intervention is required for implanting the INS. In 2002, a self-anchoring tined lead that allowed percutaneous placement under local anaesthesia [12] received CE Mark approval in Europe and FDA approval in the USA. The tined lead was developed to reduce the risk of lead displacement and to reduce operation time and the risk of adverse events (AEs) associated with the surgical procedure [12]. Currently, both PNE with the temporary lead (one-stage implant) and staged implantation with the permanent tined lead (two-stage implant) are available and used in clinical practice. Another important surgical modification was placing the INS in the upper buttock region instead of the anterior abdominal wall, which considerably speeds the surgery (from ≈ 2.5 h to 1–1.5 h), the incidence of postoperative pain and infections, and the surgical revision rate due to pain [13]. EFFICACY OF SNM MULTICENTRE RANDOMIZED CONTROLLED TRIALS (RCTs) Between 1993 and 1998, a multicentre RCT was used to evaluate the efficacy of SNM in patients with refractory UUI, frequencyurgency symptoms and UR, treated in Europe, Canada and the USA. All patients were implanted using the classical one-stage procedure. In 1999, Schmidt et al. [14] published the results of the 155 patients with refractory UUI enrolled in that study; 98 patients (63%) had a successful PNE test stimulation, i.e. > 50% improvement in voiding symptoms from baseline. Of these, 76 patients were included FIG. 1. Prescription persistency rates of OAB medications among patients new to the market (N = 21 362); prescriptions are done monthly [3]. 0% 20% 40% 60% 80% 100% Prescription % patients 1 2 3 4 5 12 FIG. 2. SNM with InterStim Therapy: (a) temporary test phase and (b) permanent implantation phase. a b S A C R A L N E U R O M O D U L AT I O N F O R O V E R A C T I V E B L A D D E R A N D U R I N A R Y R E T E N T I O N © 2 0 07 T H E A U T H O R J O U R N A L C O M P I L A T I O N © 2 0 07 B J U I N T E R N A T I O N A L 41 9 in an interim analysis and randomized for immediate implantation (stimulation group, N = 34) or delayed implantation (control group, N = 42). After 6 months the mean number of daily UI episodes, the mean severity of UI episodes and the mean number of pads or diapers used per day decreased significantly more in patients in the stimulation group than in those in the control group ( P < 0.001) (Fig. 3). Of the patients in the stimulation group, 76% were successfully treated with SNM after 6 months, i.e. 47% were completely dry and another 29% had a ≥ 50% reduction in the number of daily UI episodes. Sustained clinical benefit was reported at 18 months after implantation. UI symptoms of the patients in the stimulation group returned to baseline levels when stimulation was inactivated. Similar results were obtained in 51 patients with refractory frequency-urgency symptoms included in the multicentre trial [15]. After 6 months, the mean number of daily voiding episodes, mean voided volume and the degree of urgency were improved significantly more in the 25 patients in the stimulation group than in the 26 in the control group ( P < 0.001; Fig. 4); 64% of patients had a ≥ 50% increase in voided volume and 56% of patients had a ≥ 50% reduction in the number of daily voids or returned to normal voiding (4–7 voids/day). There was sustained efficacy of SNM at 12 and 24 months after implantation. Symptoms returned to baseline values after temporary inactivation of the INS. In 2001 Jonas et al. [16] published the results of the study in 177 patients with refractory idiopathic UR; of the 68 patients who qualified for permanent implantation (i.e. had a ≥ 50% improvement in catheter volume per catheterization during PNE test stimulation), 37 were randomly assigned to permanent SNM and 31 had delayed implantation after 6 months. The mean catheter volume per catheterization and the mean number of daily catheterizations were reduced significantly more in patients who were permanently implanted than in those in the delayed control group ( P < 0.001; Fig. 5). SNM was successful in 83% of patients, including 69% who stopped using catheters at 6 months after implantation, and 14% with a reduction of ≥ 50% in catheter volume per catheterization. The effects of SNM were sustained at 18 months after implantation. Temporary inactivation of SNM resulted in a significant increase in postvoid residual urine volume ( P < 0.001). In 2000, Weil et al. [17] published the results of another RCT including 123 patients with refractory voiding dysfunction. After successful PNE, 44 patients with refractory UUI were randomized to either permanent implantation of the INS (N = 21) or conservative treatment (N = 23). After 6 months the mean number of UI episodes and pad usage in implanted patients were 90% and 92% lower than the baseline values. Reductions in UI episodes and pad usage of ≥ 90% were achieved in 75% and 85% of implanted patients, respectively, but in none of the patients of the control group. In addition, the study showed a significant improvement in mean bladder capacity at first contraction and maximum fill, assessed by cystometry at 6 months after implantation ( P < 0.05). CASE SERIES The results of the RCTs have been confirmed in many case series; most of these studies included patients who had previously been treated with pharmacological therapy or surgery. A recently published systematic review showed that in patients with UUI, outcome measures such as UI episodes, UI severity, pad use, voiding frequency and urodynamic variables in case series are largely consistent with those of the RCTs [18]. In these series, 67% of patients became dry or achieved a ≥ 50% improvement in symptoms. Recently, a report of a Swiss registry including 209 patients was published [19]. Test stimulation was successful (improvement of > 50% in bladder/pain diary variables) in 49% of patients, 44% (including 71 with UUI and FIG. 3. SNM significantly improves urinary incontinence in patients with UUI. * P < 0.001 vs control group [14]. * * 0 2 4 6 8 10 12 Control (N = 42) SNM (N = 34) Control (N = 42) SNM (N = 34) Baseline After 6 months SNM Mean number of incontinent episodes/day Mean number of pads or diapers used/day FIG. 4. SNM significantly improves (a) the mean number of daily voids and (b) the mean voided volume, in patients with urgency-frequency symptoms. * P < 0.001 vs control group [15]. * 0 2 4 6 8 10 12 14 16 18 Control (N = 26) SNM (N = 25) Control (N = 26) SNM (N = 25) Mean number of daily voids 0 50 100 150 200 250 Mean voided volume, mL Baseline After 6 months SNM Baseline After 6 months SNM * a b FIG. 5. SNM significantly improves (a) the mean catheter volume per catheterization and (b) the mean number of daily catheterizations in patients with non-obstructive UR. * P < 0.001 vs control group [16]. 0 50 100 150 200 250 300 350 Control (N = 31) SNM (N = 37) Control (N = 31) SNM (N = 37) Mean catheter volume/ catheterisation, mL Baseline After 6 months SNM Baseline After 6 months SNM * 0 2 4 6 Mean number of daily catheterisations * b a C H A R T I E R - K A S T L E R © 2 0 07 T H E A U T H O R 4 2 0 J O U R N A L C O M P I L A T I O N © 2 0 07 B J U I N T E R N A T I O N A L 13 with non-obstructive UR) were implanted with the INS. After a median follow-up of 24 months, SNM was successful in 70% of patients. Of the 27 patients in whom SNM failed at the last follow-up, 15 continued therapy after revision. Probably due to recent advances in implant procedures and device components, many recent studies show very favourable results; some of these are discussed below. LONG-TERM EFFICACY Several clinical trials have evaluated the longterm efficacy and safety of SNM. In 2000, follow-up data of 41 patients with UUI, 29 with urgency-frequency symptoms and 42 with UR, included in the first RCT [14–16], were published [20]. After 3 years, 56% of the patients with UUI showed a > 50% reduction in daily UI episodes; 32% of them were completely dry. After 2 years, 34% of the patients with urgency-frequency had a > 50% reduction in the number of voids per day and 70% of the patients with UR had a > 50% reduction in catheter volume per catheterization after 1.5 years. Figure 6 shows the success rate in the three patient groups at 6 months and in the long term. In 2002, Scheepens et al. [21] evaluated the long-term efficacy and safety results of 15 patients (seven with UUI, seven with UR and one with both) who had the two-stage implant procedure between 1991 and 1998. Before using the two-stage technique, all patients had one or more PNE tests (mean number 2.1) that failed in the subchronic phase. One patient was explanted after the first stage; two others were explanted after permanent implantation of the INS because of infection. After a median follow-up of 4.9 years there were significant improvements in almost all voiding diary variables in the 12 patients with a successful implant, and 11 also perceived a subjective improvement and were satisfied with the therapy. More recently, single-centre studies showed favourable long-term outcomes of SNM in different patient groups, including those with urgency-frequency, UUI and UR [22,23]. One study evaluated the long-term outcomes of SNM in 107 patients with OAB (UUI or urgency-frequency) and 42 with UR who had successful one- or two-stage implants [23]. After a mean follow-up of 69.8 months for patients with OAB and 70.5 months for those with UR, 16 (11%) had a reprogramming session. At the time of their last follow-up or 3–6 months after reprogramming, 64% of the patients with OAB and 76% of those with UR had good results (complete and lasting disappearance of symptoms or satisfactory symptoms for the patient). Sutherland et al. [24] recently published a report of their 11-year experience with SNM in 144 patients. After a mean (range) follow-up of 22 (3–162) months the sustained subjective improvement was > 50% in 69% of patients, > 80% in half of the patients and > 90% in 35% of the patients. Quality-of-life (QoL) analysis showed that 61% of patients were satisfied with their current urinary condition, and only 16% were dissatisfied. There was a good overall lead durability. These studies show that the favourable effects of SNM are maintained during long-term followup in most patients with UUI, OAB or UR. ONE- VS TWO-STAGED IMPLANT Several case series compared the efficacy and safety outcomes in patients implanted with the one-stage and the two-stage procedure. In a study by Everaert et al. [25], 42 patients with UR and/or OAB symptoms were randomized to a one- or two-stage implant (21 in each group). After a follow-up of 24 months, subjective (visual analogue scale) and objective (voided volume and residual urine) variables had improved significantly more in the two-stage than in the one-stage group ( P < 0.05). Failures were more frequent in the one-stage group (7) than in the twostage group (3; P = 0.02). The results of that study suggested that the two-stage implantation procedure has a higher success rate than a one-stage implant. Recently, both test techniques were directly compared in a study including 30 women with UUI [26]. Thirteen patients were selected for PNE and 17 for test stimulation with a permanent tined lead. SNM with the permanent lead led to permanent implantation of the INS in significantly more patients than with PNE (88% vs 46%, P = 0.02). Responders to both test stimulation techniques had similar improvements in 24-h pad weight, daily pad usage, daily UI episodes and the visual analogue pain scale. Another study in 20 patients suggested that a prolonged testing period with the permanent lead (14 days for unilateral and 28 days for bilateral leads) might be a more reliable method to select patients eligible for INS implantation than the usual evaluation period of 4–7 days [27]. QOL As OAB and UR can seriously interfere with a person’s daily activities and social life, the impact of a treatment on QoL is an important efficacy measure in these patients. The effect of SNM on the patients’ health-related QoL in 89 patients with UUI, urgency-frequency or UR included in first multicentre RCT [14–16] was evaluated using the Beck Depression Inventory and the Short-form 36 instruments [28]. At baseline, 73% of the patients had a detectable level of depression. Depression and health-related QoL improved significantly in patients in the stimulation group, whereas patients in the control group (delayed implant) reported a slight worsening. The improvements in the stimulation group were maintained throughout the 6-month trial period. QoL was also assessed in several case series. Significant improvements in self-perceived UI severity (using a 22-item, domain-specific questionnaire) and Incontinence Impact Questionnaire (IIQ) score were documented in patients with UUI, UR or other urinary conditions [29,30]. Foster et al. [31] recently evaluated patient satisfaction in 49 patients who were implanted for ≥ 1 year. The results show that 84% of the respondents were satisfied with the therapy and that 80% ‘would do it all over again’. The patients’ FIG. 6. The success rate ( ≥ 50% improvement) in patients with refractory UUI, urgency-frequency and UR in the short term (at 6 months) [11–13] and long-term [18]; between brackets, patients treated at 6 months/long-term. 0% 20% 40% 60% 80% 100% Urgency- Frequency (N = 25/29) UR (N = 37/42) % of patients with ≥ 50% improvment Short-term Long-term UUI (N = 34/41) S A C R A L N E U R O M O D U L AT I O N F O R O V E R A C T I V E B L A D D E R A N D U R I N A R Y R E T E N T I O N © 2 0 07 T H E A U T H O R J O U R N A L C O M P I L A T I O N © 2 0 07 B J U I N T E R N A T I O N A L 4 21 satisfaction correlated significantly with the IIQ score; the IIQ score and 24-h pad weight improved significantly more in patients who were satisfied with the treatment than in those who were dissatisfied. OTHER INDICATIONS AND RESEARCH SNM is not only effective in patients with non-obstructive UR and idiopathic OAB; several studies have also shown positive effects in patients with neurogenic OAB, in those with dual UI and fecal incontinence, and in those with interstitial cystitis [32]. Recent studies also indicate that the pudendal nerve could become a promising target for continuous lower urinary tract modulation by implant [33,34]. SAFETY OF SNM AEs from SNM can be related to the physical presence of the device or to adverse stimulation. The pooled safety results of the first multicentre RCT using the classical onestage procedure show that, after 3 years, AEs occurred in 18.2% of the 914 PNE test stimulation procedures performed in 581 patients [20]. The most commonly reported AEs were lead migration (11.8%), technical problems (2.6%) and pain (2.1%). Of the 219 patients who received a permanent INS, 15.3% reported pain at the INS site, 9.0% new pain, 8.4% suspected lead migration, 6.1% infection, 5.5% transient electric shock and 5.4% pain at lead site. Surgical revision (relocation of the INS or revision of the lead) was required in 33% of the implanted patients. The INS was explanted in 10.5% of patients due to lack of efficacy. No serious AEs or permanent injuries were reported. Adverse stimulation does not necessarily require surgical intervention. It can often be reduced by changing stimulation factors such as electrode configuration, pulse width, amplitude, mode or polarity. Scar pain can be adequately treated by antibiotics, while device pain might require relocation of the INS. Lead migration can often be resolved by reprogramming the electrode configuration and replacing or relocating device components. This can be illustrated by the recently published follow-up data of 161 patients who received a permanent INS using the two-stage procedure with the tined lead, in one institution. After a mean of 16 months, 10.5% of the patients were explanted due to loss of efficacy or infection [35]. In 16.1% of the patients, complications (INS site discomfort in 2.5%, lead migration in 0.6% and infection in 2.5%) or decreased efficacy (10.5%) could be managed successfully in a revision session. As the incidence of lead migration and pain at the INS site were much more common in previous studies than in this study, the investigators suggested that the introduction of the tined lead and buttock placement of the INS has reduced the occurrence of lead migration and pain at the INS site. Recently, a retrospective study in 107 patients with OAB and 42 with UR with a follow-up of 64 months showed a significant difference in re-operation rates in patients implanted before or after 1995 (revision/implant ratio 1.56 vs 0.49, P < 0.001; Fig. 7) [23]. It was suggested that this development reflects the accumulation of experience in patient selection, and improvements in implant techniques and devices. These studies provide evidence for the theory that optimization and improvement of test stimulation procedures and surgical implantation techniques, and the introduction of new device components, has markedly reduced the risk of AEs. Probably this positive development also reflects the experience gained by physicians. CONCLUSIONS First-line and conservative treatment for OAB, with or without UI, and non-obstructive UR, is often insufficient to alleviate the bothersome symptoms that are associated with these conditions. Until recently, the only alternative for patients with OAB refractory to conservative treatment was surgery, which is irreversible and not always well accepted by patients with no other concomitant disease(s), has variable efficacy, and is associated with significant morbidity. The most recent ICI guidelines recommended the use of SNM as an alternative before surgery for patients with refractory (wet or dry) OAB. SNM restores both the storage and voiding phase of the micturition cycle, and therefore in the last decades more clinical trials have supported its use in patients with OAB (without affecting the voiding phase) and in patients with non-obstructive UR. Several studies have shown favourable short- and long-term effects of SNM on lower urinary tract symptoms and QoL in different patient groups. Along with the development of improved test stimulation procedures, surgical implantation techniques and device components, SNM has developed from an elaborate technique to a safe and increasingly effective minimally invasive technique that can be easily applied under local anaesthesia in an outpatient setting. The staged implant procedure allows a prolonged test period and requires only a minor surgical intervention for implanting the INS. Due to the introduction of the selfanchoring tined lead, the first stage of this technique can now be done percutaneously under local anaesthesia. Several studies have shown that the staged implant procedure and the tined lead markedly reduce the operative duration and the risk of lead displacement, and allow more reliable patient selection, with fewer false-negative test results than with the traditional PNE. Another improvement to the implant technique, placing the INS in the upper buttock region instead of the anterior abdominal wall, further speeds the surgery and reduces the risk of pain-related AEs and re-operation rates. Recent clinical studies with SNM tend to have very favourable outcomes, suggesting that the recent advances in test and implant procedures, the increasingly proactive approach towards AEs, and the growing experience of physicians with the technique, indeed lead to a better success rate. Therefore, it can be concluded that despite the fact that some patients will not respond during the test period, and some with a permanent implant will not optimally respond in the long term, > 10 years of experience and research have shown clearly that SNM with InterStim therapy is a very valuable secondline treatment option for alleviating the FIG. 7. The difference in re-operation rates in patients implanted before or after 1995 [23]. P < 0.0001 0,0 0,5 1,0 1,5 2,0 Patients implanted before 1995 Patients implanted after 1995 Revision/implant ratio C H A R T I E R - K A S T L E R © 2 0 07 T H E A U T H O R 4 2 2 J O U R N A L C O M P I L A T I O N © 2 0 07 B J U I N T E R N A T I O N A L suffering of patients with refractory voiding dysfunction. Its use earlier in the course of the disease and its efficacy when stimulating the pudendal nerve deserve further evaluation. ACKNOWLEDGEMENTS The author is grateful to Ismar Healthcare NV for their assistance in editing of the manuscript. CONFLICT OF INTEREST None declared. REFERENCES 1 Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21 : 167– 78 2 Abrams P, Andersson KE, Brubaker L et al. 3rd International Consultation on Incontinence. 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Long-term results of sacral neuromodulation for women with urinary retention. BJU Int 2004; 94: 335–7 23 van Voskuilen AC, Oerlemans DJ, Weil EH, de Bie RA, Van Kerrebroeck PE. Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study. Eur Urol 2006; 49: 366–72 24 Sutherland SE, Lavers A, Carlson A, Holtz C, Kesha J, Siegel SW. Sacral nerve stimulation for voiding dysfunction: one institution’s 11-year experience. Neurourol Urodyn 2007; 26: 19–28 25 Everaert K, Kerckhaert W, Caluwaerts H et al. A prospective randomized trial comparing the 1-stage with the 2-stage implantation of a pulse generator in patients with pelvic floor dysfunction selected for sacral nerve stimulation. Eur Urol 2004; 45: 649–54 26 Borawski KM, Foster RT, Webster GD, Amundsen CL. Predicting implantation with a neuromodulator using two different test stimulation techniques: a prospective randomized study in urge incontinent women. Neurourol Urodyn 2007; 26: 14–8 27 Kessler TM, Madersbacher H, Kiss G. Prolonged sacral neuromodulation testing using permanent leads: a more reliable patient selection method? Eur Urol 2005; 47: 660–5 28 Das AK, Carlson AM, Hull M. Improvement in depression and healthS A C R A L N E U R O M O D U L AT I O N F O R O V E R A C T I V E B L A D D E R A N D U R I N A R Y R E T E N T I O N © 2 0 07 T H E A U T H O R J O U R N A L C O M P I L A T I O N © 2 0 07 B J U I N T E R N A T I O N A L 4 2 3 related quality of life after sacral nerve stimulation therapy for treatment of voiding dysfunction. Urology 2004; 64: 62–8 29 Cappellano F, Bertapelle P, Spinelli M et al. Quality of life assessment in patients who undergo sacral neuromodulation implantation for urge incontinence: an additional tool for evaluating outcome. J Urol 2001; 166: 2277–80 30 Amundsen CL, Romero AA, Jamison MG, Webster GD. Sacral neuromodulation for intractable urge incontinence: are there factors associated with cure? Urology 2005; 66: 746–50 31 Foster RT, Anoia EJ, Webster GD, Amundsen CL. In patients undergoing neuromodulation for intractable urge incontinence a reduction in 24-hr pad weight after the initial test stimulation best predicts long-term patient satisfaction. Neurourol Urodyn 2007; 26: 213–7 32 Bernstein AJ, Peters KM. Expanding indications for neuromodulation. Urol Clin North Am 2005; 32: 59–63 33 Spinelli M, Malaguti S, Giardiello G, Lazzeri M, Tarantola J, Van den Hombergh U. A new minimally invasive procedure for pudendal nerve stimulation to treat neurogenic bladder. description of the method and preliminary data. Neurourol Urodyn 2005; 24: 305–9 34 Reitz A, Gobeaux N, Mozer P, Delmas V, Richard F, Chartier-Kastler E. Topographic anatomy of a new posterior approach to the pudendal nerve for stimulation. Eur Urol 2007; 51: 1350–5 35 Hijaz A, Vasavada SP, Daneshgari F, Frinjari H, Goldman H, Rackley R. Complications and troubleshooting of two-stage sacral neuromodulation therapy: a singleinstitution experience. Urology 2006; 68: 533–7 Correspondence: Emmanuel Chartier-Kastler, Department of Urology, Hospital Pitié- Salpêtrière, Boulevard de L’Hôpital 83, 75013 Paris, France. e-mail: emmanuel.chartier-kastler@psl. aphp.fr Abbreviations: OAB, overactive bladder; (U)UI, (urge) urinary incontinence; ICI, International Consultation on Incontinence; UR, urinary retention; (S)NM, (sacral) neuromodulation; INS, implantable neurostimulator; FDA, Food and Drug Administration; PNE, percutaneous nerve evaluation (test); AE, adverse event; RCT, randomized controlled trial; QoL, quality-oflife; IIQ, Incontinence Impact Questionnaire.

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