SACRAL NEUROMODULATION FOR THE TREATMENT OF REFRACTORY LOWER URINARY TRACT DYSFUNCTION: RESULTS FROM A MULTICENTER STUDY

Hypothesis / aims of study Sacral neuromodulation (SNM) has been used as a safe, effective treatment option for patients with lower urinary tract dysfunction (LUTD). Several clinical studies demonstrated its positive effects on refractory urge incontinence, non-obstructive urinary retention, urgency frequency syndrome, as well as on other non urological disorders, such as faecal incontinence and chronic constipation. The aim of this research project was to evaluate the efficacy and safety of sacral neuromodulation on the management of LUTD refractory to the standardised first line treatment options. Study design, materials and methods We retrospectively collected and evaluated data from patients undergoing SNM between September 2001 and November 2010 in 4 Urological Centres of Northeast Italy. The patients were affected by Overactive Bladder Syndrome (OAB) and non-obstructive Urinary Retention (UR). All the patients were evaluated with voiding diaries, before and after implantation. Patients included in the present evaluation were followed in a network of 4 Italian urological centres which participate to the Italian Clinical Service project - a national urological database and medical care project aiming at describing and improving the use of implantable urological devices in the Italian clinical practice. To evaluate the patient reported outcome (PRO) of the impact of SNM on refractory OAB, we retrospective revised files from all implanted patients who completed pre and post-operatively the King\u2019s Health Questionnaire (KHQ). KHQ is a specific assessment instrument of the heath related quality of life (HRQoL) for patients with OAB, and incontinence symptoms. It consists of 21 items distributed in nine dimensions: general health (GH), incontinence impact (II), role limitations (RLs), personal limitations (PLs), social limitations (SLs), personal relationship (PR), emotions (Em), sleep/energy (Slp/En), and severity measures (SMs). The score of each dimension ranges from 0 (lower OAB symptoms impact; better HRQoL) to 100 (higher OAB symptoms impact; worse HRQoL). Continuous normally distributed variables were reported as the mean value \ub1 standard deviation (SD). Continuous non-normally distributed variables were presented as the median values and an interquartile range (IQR). The t-test, the Mann-Whitney and Wilcoxon tests were used to compare continuous variables, as appropriate. A two-sided p < 0.05 was considered statistically significant. Results Overall, 135 patients underwent implantation of SNM during the period under review. Eighty-three out of 135 (61.5%) patients complained of OAB, and 52 (38.5%) of UR. In patients treated for OAB, we documented a statistically significant reduction in the mean number of: incontinence episodes/die, pads/die, daily micturitions, nocturnal micturitions and global micturitions (see table I). In patients treated for UR, we observed a statistically significant reduction in the mean post voiding residual volume and in the number of self catheterization (see table II). Concerning the impact of SNM on HRQOL from patients complaining of refractory OAB, only nineteen patients (17 female and 2 male), from a single centre, filled-in the KHQ pre- and/or postoperatively The median patients\u2019 age was 70 years (range 65-74) with a median follow-up of 42 months (range 17.5-48). Median and range of quality of life KHQ of general health and personal relationship pre- and post-operatively were reported in table III. Table I. SNM clinical outcomes in patients with refractory OAB Variable N Baseline FU P-value Incontinence episode/die, mean\ub1SD 48 4.1\ub12.7 1.5\ub12.1 <0.001\ub0 Pads/die, mean\ub1SD 44 3.4\ub12.4 1.3\ub11.4 <0.001\ub0 Voided volume, mean\ub1SD 45 143.6\ub169.9 206.7\ub188.5 <0.001* Daily micturition, mean\ub1SD 48 10.4\ub14.2 7.4\ub12.5 <0.001\ub0 Nightly micturition, mean\ub1SD 48 2.6\ub11.8 0.8\ub10.9 <0.001\ub0 Global micturition, mean\ub1SD 48 13.0\ub15.3 8.1\ub12.7 <0.001\ub0 *T-Test; \ub0 Wilcoxon test Table II. SNM clinical outcomes in patients with non-obstructive urinary retention Variabile N Baseline FU P-value Post void reisdual urine, mean\ub1SD 30 321.4\ub1153.5 87.2\ub196.9 <0.001\ub0 Catheterism/die, mean\ub1SD 30 3.8\ub11.4 1.3\ub11.3 <0.001\ub0 Daily micturition, mean\ub1SD 29 4.7\ub13.8 5.4\ub12.0 0.159\ub0 Nightly micturition, mean\ub1SD 29 0.7\ub11.3 0.7\ub11.1 0.886\ub0 Global micturition, ,mean\ub1SD 29 5.4\ub14.6 6.1\ub12.5 0.328\ub0 *T-Test; \ub0 Wilcoxon test Table III. Median and range of HRQoL assessed pre- and postoperatively by King\u2019s Health Questionnaire* of general health and personal relationship of patients underwent SNM for refractory OAB. Dimension pre-SNM median (rance) post-SNM median (range) p-Value Wilcoxon matched pairs test GH 50 (37.5-50) 50 (25-62.5) 1 II 100 (100-100) 100 (50-100) 0.063 RLs 83.3 (50-100) 50 (33.3-100) 0.102 PLs 83.3 (66.7-100) 33.3 (16.7-83.3) 0.026 SLs 77.8 (50-94.4) 0 (0-50) 0.017 PR 0 (0-25) 0 (0-33.3) 0.785 Em 77.8 (22.2-88.9) 33.3 (11.1-44.4) 0.14 Slp/En 50 (33.3-75) 50 (16.7-66.7) 0.109 SMs 58.3 (33.3-79.2) 66.7 (25-75) 0.671 *The score ranges from 0 (lower OAB symptoms, better HRQoL) to 100 (higher OAB symptoms, worse HRQoL). In comparison of the preoperative setting, patients after the implant showed a better scores in many KHQ dimensions. In particular for personal limitations (p=0.026), and social limitations (p=0.017). The length of follow-up did not significantly impact on HRQoL scores. Interpretation of results SNM offers objective benefits for people with refractory OAB and for those with urinary retention without structural obstruction. Concerning the PRO, because OAB symptoms in general may have a serious impact on a person\u2019s daily activities and social life, the effect of treatment on disease-specific HRQoL also reflects its efficacy. In our series we observe a significant improvement of HRQoL for the following KHQ items: personal limitations and social limitations. We observe a better, although not significant, HRQoL also for the following items: Incontinence Impact, Role Limitations, and Emotions. We did not found any correlation between the follow-up length and HRQoL. We should take great caution in interpreting these results because all the measures of the impact of SNM on the HRQOL comes from a small number of patients\u2019 perspective. Concluding message This multicenter research project confirmed the midterm safety and effectiveness of sacral neuromodulation in the treatment of refractory overactive bladder syndrome and non-obstructive urinary retention, showing high cure rates and low complication rates

ROLE OF SYMPTOMS DURATION AS PROGNOSTICATOR FOR SACRAL NEUROMODULATION IN REFRACTORY OVERACTIVE BLADDER

Hypothesis / aims of study Sacral neuromodulation (SNM) offers a well-tolerated treatment option for patients with overactive bladder syndrome (OAB) refractory to conservative treatment. The advantageous effect of SNM depends on the accurate identification of suitable candidates during pre-implant percutaneous nerve evaluation. In the Literature there are conflicting data regarding the role of age, duration of complaints and neurogenic bladder dysfunction in predicting the effect of SNM, and up to-date no specific urological pre-treatment factors have been associated with response to SNM. The aim of this multicentric study was to investigate data from 103 patients with refractoy OAB who underwent SNM implant in order to evaluate the role of symptoms duration as possible pre-treatment prognosticator. Study design, materials and methods From September 2001 to November 2010 a total of 103 patients attending four different urological centres with refractory OAB underwent a temporary SNM implant. Patient data (demographics, medical history,urologic investigations, and diagnosis) were collected. Temporary implant results were evaluated from a voiding diary and patient history. More than 50% improvement of voiding parameters was considered a successful SNM and those patients were selected for implantation. We test the duration of complaints as prognosticator for predicting SNM result. We performed the Pearson correlation analysis. For comparison between groups either Student's t test or Mann-Whitney test were used, as appropriate. Results Eighty patients (77%) underwent a definitive implant. At a mean follow-up of 25.2 \uf0b1 22.9 months we observed a significant decrease (p<0.001) in the mean number of incontinence episodes/die (1.3\ub1 1.9 versus 4.6\ub12.4), number of pads/die (1.2 \ub1 1.4 versus 3.7 \ub1 2.2), daily urinary frequency (8.7 \ub1 2.8 micturitions/die versus 12.7 \ub1 4.8). Stratifying patients according to the lower urinary tract dysfunction aetiology (idiopathic, neurogenic, iatrogenic), we did not find any significant correlation between symptoms duration (neither as continuous nor categorical variables) and the improvement rates of incontinence episodes (figures 1-2), and micturition frequency (figures 3-4), although we observed better results mainly in neurogenic patients with < 4- year history of urinary symptoms (figure 5). Interpretation of results Patients with urgency and urge urinary incontinence due to neurogenic lower urinary tract dysfunction for a relatively long period of time may have a lower chance of a positive test compared with patients with neurogenic dysfunction for a relatively short period. Concluding message Duration of complaints was not found to be significant predictive factor for the success of SNM. Disclosure

Micronized Palmitoylethanolamide-Polydatin Reduces the Painful Symptomatology in Patients with Interstitial Cystitis/Bladder Pain Syndrome

Aims. To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies. Methods. A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O’Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time. Results. A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment (p&lt;0.0001 for reduction over time). The effect was associated with a reduction in severity of patients’ symptoms evaluated with the O’Leary-Sant questionnaire (p=0.0110 and p=0.0014 for cystitis symptoms and problem mean scores, respectively) and the PUF scale (p=0.0163 and p=0.0005 for symptom and bother mean scores, respectively). m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary (p=0.0005) and a small but not significant improvement of bladder capacity. Conclusions. These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products.</jats:p

New tined lead electrode in sacral neuromodulation: experience from a multicentre European study.

Item does not contain fulltextThe use of a new tined lead electrode for sacral neuromodulation (SNS) was evaluated in a European study including 127 patients with chronic voiding dysfunction. The tined lead can be implanted during the first stage of the SNS procedure, which makes a longer test period possible before implanting the pulse generator in a second stage. Implantation of the tined lead was performed under local anaesthesia in 89% of patients. Screening lasted on average 30 days. Screening with the tined lead was considered successful by the physicians in 77% of patients (n=72). In 74% of first stage patients (n=70), at least 50% improvement in the main symptoms versus baseline was obtained. This was sustained for up to 6 weeks. All of these patients received the pulse generator in a second stage. The outcome of this study supports the use of the tined lead electrode as a screening tool in SNS therapy