Sacral neurostimulation for urinary retention: 10-year experience from one UK centre

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1 Original Articles SACRAL NEUROSTIMULATION FOR URINARY RETENTIONDATTA ET AL. Sacral neurostimulation for urinary retention: 1-year experience from one UK centre Soumendra N. Datta, Charlotte Chaliha, Anubha Singh, Gwen Gonzales, Vibhash C. Mishra, Rajesh B.C. Kavia, Neil Kitchen*, Clare J. Fowler and Sohier Elneil Departments of Uro-Neurology and *Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK Accepted for publication 13 July 27 Study Type Therapy (individual cohort study) Level of Evidence 2b OBJECTIVES To report our 1-year experience of sacral neurostimulation (SNS) for women in urinary retention, comparing the original one-stage with the newer two-stage technique, as SNS therapy is a well-established treatment for urinary retention secondary to urethral sphincter overactivity (Fowler s syndrome). PATIENTS AND METHODS Between 1996 and 26, 6 patients with urinary retention had a SNS device inserted; their case records were reviewed and data on efficacy, follow-up, need for continued clean intermittent self-catheterization (CISC), complications and operative revision rate were assessed. RESULTS Overall, 43 of 6 (72%) women were voiding spontaneously, with a mean postvoid residual volume of 1 ml; 3 (5%) no longer needed to use CISC. During a total of 2878 months of SNS experience, adverse event episodes included lead migration in 2, box-site pain in 19, leg pain/numbness in 18 and loss of response/failure in 18 patients; 53% of the women required a surgical revision related to their implanted stimulator. The efficacy of the two-stage was similar to that of the one-stage procedure (73% vs 7%). Women with a normal urethral sphincter electromyogram had worse outcomes than women with an abnormal test (43% vs 76%). Although the efficacy was no different in those taking analgesia/ antidepressant medication, this group of women had a higher surgical revision rate. Failure and complications for the one-stage procedure were not restricted to the early follow-up period. The mean battery life of the implant was 7.31 years. CONCLUSIONS SNS has sustained long-term efficacy but the procedure has a significant complication rate. At present, the two-stage technique has comparable efficacy to the one-stage technique but a longer-term follow-up is required. The National Institute of Clinical Excellence recommended the use of SNS in women with urinary incontinence who fail to respond adequately to anticholinergic therapy, but patients choosing this treatment should be made aware of the high complication rate associated with the procedure. KEYWORDS sacral neuromodulation, urinary retention, Fowler s syndrome, voiding dysfunction INTRODUCTION Sacral neurostimulation (SNS) has been shown to be the only effective therapy in women with urinary retention and voiding dysfunction secondary to urethral sphincter overactivity (Fowler s syndrome) [1,2]. We previously reported on the original implantation technique that was used in our unit [1], and at 5 years of follow-up 77% of the patients who previously had significant impairment or urinary retention were able to void [3]. Despite the confirmed efficacy, the procedure has significant complications, both at our and other centres when the same technique is used [1,4]. This includes lead migration, pain at the site of the implantable pulse generator (IPG), leg pain, infection and, over time, failure of the device. The one-stage procedure involved an initial test stage using a percutaneous nerve evaluation (PNE) test by implanting a temporary stimulating electrode through the S3 foramen, positioned to produce the sensation of vaginal or rectal tingling or contraction. The electrode was then kept in situ for 4 7 days attached to a temporary battery, and voiding diaries kept to record any improvement in voiding function. If voiding was shown to improve, the patients were offered a permanent stimulator. A different electrode was inserted using an open sacral procedure, and connected to a permanent IPG either within the buttock or placed within the subcutaneous fat of the anterior abdominal wall. Reports of these procedures showed there were several drawbacks, as up to 4% of patients who responded to the temporary PNE did not void when the permanent electrode was inserted, a possible reason being that the site of permanent electrode implantation might have differed from that of the successful PNE electrode [5]. Conversely, the PNE temporary electrode might not be optimally placed, leading to failure and patients not proceeding to permanent implantation [6]. In 1997 a new two-stage technique was introduced, with a tined electrode and using a minimally invasive approach [6,7]. This has a longer test phase to evaluate the procedure. Early data suggested that this had a higher success rate of up to 8% [8,9] and this has been our adopted method since 24. We now have a cohort of patients who have had the one-stage stimulator implanted for 192 JOURNAL COMPILATION 27 BJU INTERNATIONAL 11, doi:1.1111/j x x

2 SACRAL NEUROSTIMULATION FOR URINARY RETENTION TABLE 1 The efficacy of SNS with procedure (3 patients each), the complications, and the urethral investigations Variable One-stage Two-stage Total Mean (range): age at insertion, years follow-up, months 84.2 ( ) 11.7 ( ) 48. Spontaneous voiding, n (%) (>2 ml) 21 (7) 22 (73) 43 (72) N (%) also requiring CISC 5 (17) 8 (27) 13 (22) Mean (range) PVR, ml (in voiders) 85.7 ( 25) ( 42) 1 Successful PNE, n/n (%) 3/3 (1) 21/29 (72) 51/59 (86) Voiding, % CISC assisted voiding, % Not voiding, % Failures Stimulator removed, n (%) 7 (23) 5 (17) 12 (2) Complication Major AEs Minor AEs Surgical revisions No. patients requiring surgical revision, n (%) (53) Urethral investigations (n) UPP, cmh 2 O 16.5 (11) 11.6 (27) 13 (38) SV, ml 2.31 (11) 2.18 (25) 2.23 (36) EMG positive 21/27 12/13 33/4 >1 years, and a newer cohort implanted since 24. Herein we present the audit of a long-term follow-up of the original one-stage procedure (performed by N.K.) with the older electrode, together with more recent patients with the tined electrode, using the two-stage minimally invasive technique by a different surgeon (S.E.). The audit assessed at the success, complications and re-operation rates of both procedures. PATIENTS AND METHODS Between 1996 and 26, 6 patients were selected for SNS; the criteria for surgery included a history of voiding dysfunction with complete or partial retention, elevated urethral pressure profilometry (UPP, >1 cmh 2 O), increased urethral sphincter volume (SV, >1.8 ml) and abnormal urethral sphincter electromyography (EMG, complex repetitive discharges and decelerating bursts). A PNE procedure was used before the onestage procedure, which involved placing an electrode in the S3 foramen under local anaesthesia. The electrode was then connected to a temporary battery for 4 7 days, and if voiding was restored and there was a postvoid residual volume (PVR) of <2 ml, the patient was deemed suitable for a permanent implant. The one-stage technique used open surgery with bone suture fixation of the electrode, and with an extension lead tunnelled to the abdomen where the IPG was placed in the subcutaneous fat. The two-stage procedure involved initial insertion under general anaesthesia of a tined electrode, ideally into the S3 foramen, adjusted until positioned for maximum motor response. This electrode was then connected to an external stimulator by a temporary lead and left in place for 4 weeks, during which the patient was asked to complete voiding diaries. If voiding was restored and there was a PVR of <2 ml (the same criterion as for PNE), the temporary stage was deemed to be successful and the IPG was then implanted. Failure was defined as either no change or improvement in voiding function despite optimum electrode placement or sensation. The IPG was implanted deep within the subcutaneous fat of the buttock ipsilateral to the electrode position. At 1 day after surgery the stimulator was switched on; the IPG was set to a pulse width of 21 µs, a rate 14 Hz and with the amplitude set to just below a comfortable perineal sensation. The case records were reviewed for all patients, for the length of follow-up, return to voiding and need for catheterization, complications and number of re-operations. The regular use of analgesia and antidepressants before surgery was also noted. RESULTS Between June 1996 to June 26, 3 women had a one-stage SNS and 3 had the two-stage procedure; no patients were lost to follow-up. The mean (range) age at the time of one- and two-stage IPG insertion was 34.1 ( ) and 37.6 ( ) years, respectively. The results showing the efficacy rate are given in Table 1. Overall, there was a spontaneous voiding rate of 72% over a mean follow-up of 4 years. After surgery, of the 43 women who voided, 13 required the continued use of clean intermittent self-catheterization (CISC) up to twice a day, but this was less than before surgery. The one-stage group were selected from 125 patients screened with a PNE, of whom 53 were judged a success. In the two-stage group, eight patients had a previous negative PNE, but of these, five had a successful outcome with the two-stage procedure. In the 33 women with an abnormal EMG finding, 25 (76%) had restoration of voiding (mean duration 6.7 months). By comparison, in those seven women with a normal EMG, only three voided and had a successful outcome (mean duration 64.4 months). In 2 women who did not have a sphincter EMG and whose diagnosis was based on an elevated UPP and SV, 15 (75%) were voiding spontaneously. There were 99 adverse events (AEs) and 63 surgical revisions for the women during a total of 2878 months of SNS experience, but no patients died. There were 52 serious AEs in the one-stage and 22 in the two-stage groups (a serious AE was defined as one that required hospital admission or surgical revision to resolve); the remaining AEs were minor and resolved. Table 1 also lists the total number of AEs and repeat surgical procedures in the 6 women, and the number of patients who required surgical revision. In the one-stage procedure there were 15 lead migrations, vs two in the two-stage procedure. The types and JOURNAL COMPILATION 27 BJU INTERNATIONAL 193

3 DATTA ET AL. FIG. 1. AEs by category in the one- and two-stage techniques Single-stage 8 2 stage Box Site Loss of response PainFrequency Lead Problems Leg Pain UTI Wound Pelvic Pain Urethral Pain frequency of complications are shown in Fig. 1. Three patients in the one-stage group failed to respond to the SNS, which was then removed. Subsequently they had a two-stage procedure and they responded successfully in all cases. Two patients in the two-stage group had no response to tined lead stimulation and had the electrode removed. Figure 2 shows AEs, failure and revisional surgery from the time of implantation; notably, the AEs were not confined to early period after surgery and we cannot comment yet on the long-term complications with the two-stage procedure. Figure 3 shows the number of surgical revisions required by each patient; 14 had more than one revision (range 2 8). Figure 4 shows the number of re-operations per patient and the medication the women were taking regularly at the time of implantation. Eight (13%) women were taking regular analgesics and antidepressants, and had a mean (range) of 2. ( 6) re-operations per procedure, vs 1.9 ( 4) for those not taking any regular medications. The number of women with a successful outcome for different sites of stimulation, i.e. right S3, left S3, right S4, left S4, right S2 and left S2, was 2, 15, one, four, one and two, respectively. Women taking chronic analgesia and antidepressant medication (eight of 6) had a higher complication rate, with twice the mean re-operation rate of those not taking medication (2. vs 1.9), but there was no difference in efficacy between these groups. There were too few patients in the groups for valid statistical testing. FIG. 2. Complications, failure and surgical reoperations with time after surgery. Frequency of events The mean (range) life for the IPG battery (Interstim, Medtronic Inc., Watford, UK) in nine women who developed loss of sensation or intermittency secondary to confirmed IPG failure was 7.31 (4. 8.9) years. DISCUSSION Complications, Failure and Surgery by time after implantation Time, months after implantation SNS 1-stage Complication SNS 2-stage Failure SNS 2-stage Complication SNS 1-stage revision surgery SNS 1-stage Failure SNS 2-stage revision surgery This long-term outcome study represents our centre s experience of SNS for women with urinary retention over the last 1 years ( ). The initial cohort of patients who had the one-stage procedure had a mean follow-up of 84.2 months (7 years), with 7% voiding spontaneously. This confirms the longer-term efficacy of SNS as a treatment for unobstructive retention, and is in line with long-term data from van Voskuilen et al. [1], showing 76.2% efficacy at 7.5 months, and Elhilali et al. [11] showing an efficacy of 78% at 77 months. The present data showed a higher success rate than that of De Ridder et al. [12], of 58.6% efficacy at 6 months. Overall, the efficacy rate in the present patients of 72% at a mean follow-up of 48 months fits with previously reported results for urinary retention, showing a shortterm efficacy of 83% at 6 months [13] and our medium-term results of 77% at 37 months [1]. Groups treating patients with symptoms of urgency/frequency with SNS have shown 56% efficacy (a reduction of more than half in voiding frequency) at 2 years after implantation [14], 63.6% efficacy at 7 months [1] and a 45% benefit at 77 months [11]. In a report of 11 years of FIG. 3. The number of surgical revision(s) per patient. Number of women Number of Revision Surgical Procedures FIG. 4. The number of re-operations per patient according to preoperative regular medication. Number of re-do surgical procedures per patient No Meds Analgesia Antidepressents Analgesia And Antidepressents Whole Group experience, where SNS therapy was predominantly (8%) used for urgency/ frequency with or without incontinence, only 6% of patients rated that they were satisfied in a quality-of-life survey [15]. The long-term efficacy rate for SNS in patients with functional urinary retention seems to be consistently better, by 1 15%, than it is for urgency/frequency with or without incontinence. The study by De Ridder et al. [12] showed that women with urinary retention associated with specific abnormalities in the sphincter EMG (Fowler s syndrome), had a better outcome from SNS at 5 years than those with no abnormal sphincter EMG (72% vs 46%); the present results are similar, with 78% vs 43% efficacy, respectively. Not all patients having the two-stage procedure had an EMG study, as their diagnosis was based on an elevated UPP and urethral SV, that have been shown to be predictors for a positive urethral sphincter EMG [16]. In the last few years we have moved to using UPP and SV as the primary diagnostic tests for functional obstruction (Fowler s syndrome), due to greater ease of testing, only using EMG in cases where the diagnosis is uncertain [3]. In the present study there was an identical level of success from SNS in women with a EMG abnormality or diagnosed 194 JOURNAL COMPILATION 27 BJU INTERNATIONAL

4 SACRAL NEUROSTIMULATION FOR URINARY RETENTION with an elevated UPP and SV. This factor might also explain the high long-term efficacy rate in our cohort. We now regard the two-stage technique as the preferred standard rather than the PNE, and then the one-stage implant [17]. The two-stage procedure has been shown in a randomized setting to give a higher chance of a good result [8]. The success rate further improves with the use of the tined lead, as this allows anchoring and less chance of lead migration [18]. Our results show that of eight patients who had a negative PNE result but who then proceeded to the two-stage procedure, five had voiding restored. This illustrates the advantage of the two-stage technique, as was reported previously by Janknegt et al. [6]. A successful response was apparent most often by stimulation in either S3 foramina, but eight of 43 women had the electrode placed in other foramina (S2 or S4) and still voided. S2 nerve roots have been noted to carry up to 6.5% of pudendal afferent fibres [19] and this might explain the efficacy of stimulation at S2. The use of other foramina might be useful in patients who do not respond at S3, but can be associated with undesired excitation of efferent fibres innervating the lower limbs. The mean PVR at the follow-up was 1 ml; most (78%) of the women who voided did so to completion and required no further need for CISC. The remaining women (22%) voided but retained a residual of 1 2 ml, which required them to use CISC usually once (normally before sleep), but this was a major decrease from before SNS. To date SNS is the only effective treatment for voiding dysfunction, although recently there have been preliminary results showing success with botulinum toxin injected into the urethral sphincter to aid voiding [2,21]. In all, 73% of the women had an AE during their treatment with SNS (99 AEs in 6 women); a quarter of these were minor and resolved either spontaneously, or with programming and treatment. Van Voskuilen et al. [1] reported 194 events in 149 patients. The failure rate was similar for the one- and two-stage procedures; there was a reduction in the frequency of box-site pain and leadrelated events with the two-stage procedure, and we think this is because we used the buttock as the box site, and the introduced the tined quadripolar lead, which is selfanchoring. We have had fewer episodes of lead migration with the tined lead, to date, than with the previous bone or fascial anchored lead. The use of the buttock as the box site has been shown to decrease positionrelated pain, postoperative pain and infections [22]. The introduction of the tined lead has allowed a minimally invasive approach with a potential decrease in morbidity. Although there were fewer AEs and re-operations in the two-stage group, with most not requiring hospital admission or an operation to correct, these are early data and the follow-up of the two-stage cohort is considerably shorter than the one-stage group. The mean battery life of the IPGs was 7.31 years, slightly longer that 6.14 years reported by van Voskuilen et al. [1]. This costs 965/per year (price in January 27) just for the IPG; the IPG was recently redesigned and Medtronic have released the Interstim II system, which is nearly half the size and weight of the former device, and hopefully will further reduce implant-related complications. It has a smaller battery capacity, which might reduce the life of the device. Future comparison with the Interstim II IPG (life 5 years) will help determine if there is true benefit in reducing the size of the new unit. Several authors reported that patient psychiatric factors play a part in their robustness to tolerate SNS, with a poorer outcome especially in the first year and a less reliable test phase [23,24]. Spinelli et al. [25] reported a prospective study with the Minnesota Multiphase Personality Inventory 2, and showed that nine of 15 patients with idiopathic urinary retention had a somatoform disorder, and seven of eight failures had psychotic signs. We did not specifically use psychometric testing in the present patients. Although there was a trend towards a higher re-operation rate in those taking a combination of analgesics and antidepressants, possibly indicating an underlying depressive tendency, there was no relationship between this and the success of the procedure. The present surgical revision rate of 53%, although higher than that reported by van Voskuilen et al. [1] (48%) and Elhilali et al. [11] (44%). The National Institute of Health and Clinical Excellence (NICE) reported a 33% re-operation rate for SNS in their systematic review based on older data [26]. This has obvious economic implications when considering introducing this procedure. NICE recently recommended the use of SNS for treating urge urinary incontinence refractory to anticholinergic medication, with a life-long follow-up of patients and the surgery done by surgeons who are adequately trained and perform at least five cases a year [27]. Given that the trial and implantation procedures are identical to SNS for urinary retention, our results and UK experience are relevant when planning adequate resources and staff allocation to centres that will embark on this therapy. What has become evident over the past decade from the use of SNS for treating urinary retention is the need for a multidisciplinary team approach, with good continuity of care and a central point of contact. At our centre, we have devised a central access that is regularly checked, so that patients can report problems, request appointments and obtain support when needed. We are assisted tremendously in the community by the patients GPs and local urology teams. Our staff includes a dedicated neurostimulator nurse, a clinical fellow, surgeon and clinical neurophysiologist. Elsewhere, some teams have support from a medical physicist to assist programming, and a clinical psychologist to determine the suitability of patients for participating in the programme. The costs of the initial procedures, together with the high revision rate, remain a concern, and methods to overcome these will be required for this procedure to become widespread. In conclusion, SNS is currently the only confirmed long-term treatment for women in urinary retention that restores voiding ability. However, despite refinements in technique, the procedure still has disadvantages, including a significant revision rate, although this is better in the short term than with the previous one-stage procedure. The continuous development, with innovations such as the tined lead and smaller implants, should help to reduce these problems. A strategy to reduce the re-operation rate would be beneficial and save costs, especially in the light of the NICE recommendation. We highlight the need for ongoing evaluation of the procedure using strict clinical criteria. JOURNAL COMPILATION 27 BJU INTERNATIONAL 195

5 DATTA ET AL. ACKNOWLEDGEMENTS We gratefully acknowledge the Royal College of Surgeons of England for the Surgical Research Fellowship awarded to the lead author. This work was undertaken at UCLH/ UCL who received a proportion of funding from the Department of Health s NIHR Biomedical Research Centers funding scheme. CONFLICT OF INTEREST None declared. REFERENCES 1 Dasgupta R, Wiseman OJ, Kitchen N, Fowler CJ. Long-term results of sacral neuromodulation for women with urinary retention. BJU Int 24; 94: Swinn MJ, Kitchen ND, Goodwin RJ, Fowler CJ. Sacral neuromodulation for women with Fowler s syndrome. Eur Urol 2; 38: Kavia RB, Datta SN, Dasgupta R, Elneil S, Fowler CJ. Urinary retention in women: its causes and management. BJU Int 26; 97: Swinn MJ, Schott GD, Oliver SE, Kitchen ND, Fowler CJ. Leg pain after sacral neuromodulation: anatomical considerations. BJU Int 1999; 84: Bosch JL, Groen J. 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Systematic review of the efficacy and safety of sacral nerve stimulation for urinary urge incontinence and urgency frequency. Review Body for Interventional Procedures. Available at ip82systematicreview. Accessed August NICE. The management of urinary incontinence in women. Clinical Guideline. Available at CG4. Accessed August 27 Correspondence: Soheir Elneil, Department of Uro-Neurology (Internal Box 71), National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK. s.elneil@ntlworld.com Abbreviations: SNS, sacral neurostimulation; IPG, implantable pulse generator; PNE, percutaneous nerve evaluation; UPP, urethral pressure profilometry; SV, urethral sphincter volume; EMG, electromyography; PVR, postvoid residual volume; CISC, clean intermittent self-catheterization; AE, adverse event; NICE, National Institute of Health and Clinical Excellence. 196 JOURNAL COMPILATION 27 BJU INTERNATIONAL