Predictive Factors in Sacral Neuromodulation: A Systematic Review.

INTRODUCTION: Sacral neuromodulation (SNM) is an effective treatment in patients with overactive bladder syndrome or nonobstructive urinary retention when conservative treatment fails. Several factors that could impact outcome with SNM have been studied. This systematic review investigated these predictive factors and their relevance for clinical practice. METHODS: Systematic review according to the PRISMA guidelines was conducted. This review is registered in the PROSPERO register (CRD42015016256). RESULTS: Seventy-eight studies (of which 11 abstracts) were included. Females, younger patients, and a tined lead procedure tend to be predictive in successful SNM outcome. Factors that did not influence SNM outcome were prior back surgery, surgery for stress urinary incontinence, affective symptoms, and duration of complaints. Reduced detrusor contractility is associated with a lower success rate. The level of evidence of most studies (graded according to the Centre for Evidence-Based Medicine) was 3b. CONCLUSION: Even though this systematic review investigated predictive factors (gender, age, type of procedure, type of lead, and detrusor contractility), no general consensus on predictive factors could be made. Most studies are small, retrospective, and involve a heterogeneous population. Therefore, prospective research in larger specific patient groups remains necessary to find predictors of SNM outcome.

The Value of Ambulatory Urodynamics in the Evaluation of Treatment Effect of Sacral Neuromodulation.

OBJECTIVES: To assess the improvement of symptoms by sacral neuromodulation (SNM) in an objective way by carrying out an ambulatory urodynamic study (ambulatory-UDS). Until now, successful treatment has been defined as a ≥50% improvement recorded on voiding diaries. Voiding diaries are a patient reported outcome tool. A tool with less bias is desired to evaluate the treatment results before an expensive permanent system is implanted. METHODS: Between 2002 and 2015, a total of 334 patients with lower urinary tract symptoms were included consecutively in an ambulatory-UDS database. From this database, a subgroup of patients was selected which underwent SNM. RESULTS: In 51 patients, an ambulatory-UDS was performed both at baseline and during the SNM test period. A positive treatment outcome after test stimulation based on the patients' voiding diary, correlated (p < 0.0001) with an improvement on ambulatory-UDS. Twenty-six of the 30 patients, who have showed improvement of more than 50% on voiding diary parameters and who had subjective improvement of their symptoms, showed an early improvement on ambulatory-UDS. CONCLUSIONS: Ambulatory-UDS can be used in clinical decision making, as it is associated with voiding diary improvement during the SNM test period. Using ambulatory-UDS to confirm success could in the future justify the shortening of the test period.

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.

Affective symptoms and quality of life in patients with voiding or storage dysfunction: Results before and after sacral neuromodulation: A prospective follow-up study.

AIMS: Sacral neuromodulation (SNM) is an effective treatment for patients with overactive bladder syndrome (OAB) or non-obstructive urinary retention (NOR). These lower urinary tract symptoms (LUTS) are the result of a functional urological cause but often coincide with psychological and/or psychiatric factors. It has been stated that there is an association between LUTS, depression and anxiety disorders. With this study we will investigate whether affective symptoms and quality of life (QoL) improve after successful SNM. METHODS: All patients eligible for SNM between March 2013 and March 2016, filled out the HADS (Hospital Anxiety and Depression Scale), SF-36 (Short Form-36) and either the International Consultation on Incontinence Modular Questionnaire (ICIQ) on Male/Female Lower Urinary Tract Symptoms (M/F-LUTS), or the OAB-q questionnaire, before and after the test procedure. Symptom improvement of ≥50% was considered as success. Results were analyzed by paired T-tests and the Wilcoxon signed-rank test. RESULTS: In total 95 patients were included. Mean age was 52.1 (SD 13.9). Fifty-six patients (59%) were implanted. Successful OAB patients reported a significant improvement in all domains of OAB-q, health change and affective symptoms. Successful NOR patients showed a significant improvement in voiding symptoms (P = 0.04) and health change (P = 0.03). However, they did not report significant improvement in affective symptoms. CONCLUSION: QoL and affective symptoms can significantly improve in LUTS patients who are successfully treated with SNM. When divided per indication, a significant improvement in affective symptoms together with QoL was only reported in successful OAB patients and not in successfully treated NOR patients.

Prediction of sacral neuromodulation treatment success in men with impaired bladder emptying-time for a new diagnostic approach.

INTRODUCTION: Detrusor underactivity (DU) is currently a topic that receives major attention within functional urology. Urologists are often confronted with men who present with voiding dysfunction without bladder outlet obstruction (BOO) or after desobstructive or neuromodulation treatment. Their impaired bladder emptying is suspected to be related to failure of detrusor contractile function. Earlier research indicated that patients with non-obstructive urinary retention (NOR), for example, detrusor underactivity (DU), have a lower success rate after sacral neuromodulation (SNM) compared to patients treated with SNM for storage dysfunction. However, predicting factors for treatment success in the NOR group have not yet been defined. METHODS AND EVIDENCE: The aim of this study was to assess whether the use of the new BOO-contractility (Maastricht-Hannover) nomogram can identify and predict SNM non-responders. Our results in 18 men showed that only 20% of patients below the 10th percentile, but 86% of men between the 10 and 25th percentiles of the nomogram can be treated successfully with SNM. All successfully treated patients voided without needing self- catheterisation. CONCLUSIONS: This pilot study showed for the first time that SNM treatment response in male patients with impaired bladder emptying can be predicted with the BOO-contractility (Maastricht-Hannover) nomogram. Men below the 10th percentile are likely to be treatment non-responders, whereas the majority of men above the 10th percentile are responders. Neurourol. Urodynam. 36:808-810, 2017. © 2016 Wiley Periodicals, Inc.

The Impact of Duration of Complaints on Successful Outcome of Sacral Neuromodulation.

OBJECTIVES: The study aimed to evaluate whether the duration of complaints in patients with overactive bladder syndrome or non-obstructive urinary retention predicts the outcome of sacral neuromodulation (SNM). METHODS: All patients that underwent a SNM test period evaluation between 2011 and 2014, were included in this study. The duration of complaints was listed in 3 categories: (a) 0-5 years, (b) 5-10 years and (c) 10 years or longer. Analyses with chi square tests were performed to evaluate whether the duration of complaints are associated with outcome of SNM. RESULTS: In total, 130 patients were included. Most patients had a complaint duration of 0-5 years (n = 60). The test period was successful in 56% (n = 74) of the total group. Analyses showed that the duration of complaints is not significantly associated with outcome of SNM (p = 0.752), even when subdivided per indication, and also when possible confounders such as age at test and indication are taken into account (p = 0.720). CONCLUSION: Based on the results of this study, there is no relationship between duration of complaints and SNM outcome. SNM seems to remain a feasible treatment option, despite of possible anatomical or physiological changes within the lower urinary tract.

Screening for depression and anxiety in patients with storage or voiding dysfunction: A retrospective cohort study predicting outcome of sacral neuromodulation.

AIMS: It has been reported that somatic treatment in patients with affective symptoms has a higher risk of failure. The aim was to investigate whether affective symptoms could predict the outcome of sacral neuromodulation (SNM) for lower urinary tract symptoms (LUTS). METHODS: All patients that underwent a SNM evaluation between 2006 and 2013 and filled out a Hospital Anxiety and Depression Score (HADS) before treatment, were included. Chi-square analysis and bivariate logistic regression were used to assess associations and predictive value. RESULTS: Eighty-six patients were included, 65 females and 21 males. Most patients, 66, had overactive bladder syndrome (OAB). The remaining 20 patients suffered from non-obstructive urinary retention (NOR). Thirty-nine OAB patients and 17 NOR patients, had a normal total HADS score before treatment. Significantly more patients showed abnormal HADS-D (P = 0.047) and HADS-A (P = 0.015) scores in the OAB group compared to the NOR group. Success of SNM could not be predicted by the HADS score P = 0.464 (after 1 year P = 0.446). Subsequent analysis revealed that an abnormal HADS score was not related to the occurrence of SNM adverse events. CONCLUSIONS: The present study did not reveal a significant relationship between an abnormal HADS score and failure of the SNM test period in a mixed group of OAB and NOR patients. However, differences between OAB and NOR patients concerning affective symptoms were present. It is known that psychological factors play a role in the severity of LUTS, but they may not predict SNM outcome. Neurourol. Urodynam. 35:1011-1016, 2016. © 2015 Wiley Periodicals, Inc.

The value of urodynamic tools to guide patient selection in sacral neuromodulation.

PURPOSE: The aim of this study is to explore whether urodynamics, with the addition of ambulatory urodynamic study (ambulatory-UDS), will be able to better predict and assess sacral neuromodulation (SNM) treatment outcome. Selection of patients is a critical element in achieving optimal outcome in SNM. Quantitative and qualitative results of urodynamic tests are used to justify surgical therapy and to evaluate treatment for lower urinary tract dysfunction. Therefore, these tests should be representative and subsequently offer a correct prognosis. METHODS: Between December 2002 until May 2013 selected patients with lower urinary tract symptoms (storage and/or voiding dysfunction) were included in an ambulatory urodynamic measurement database. From this database, the total subgroup of patients that underwent a sacral neuromodulation test evaluation was selected. RESULTS: A total of 98 patients were included. Success rate of SNM in patients with storage dysfunction was around 70 %, according to either conventional-UDS or ambulatory-UDS diagnosis. Based on conventional-UDS, success rate of SNM in patients with hypocontractility was 67 % and in acontractile patients 35 %. According to ambulatory-UDS diagnosis, success rates were 32 and 17 %, respectively. CONCLUSIONS: This study shows that conventional-UDS overestimates the amount of patients diagnosed with hypocontractile or acontractile bladder. Patients with reduced contractility on ambulatory-UDS have a lower chance of SNM success. Hence, ambulatory-UDS allows us to select patients with a real acontractile bladder and predict SNM failure. In patients with storage dysfunction, additional ambulatory-UDS does not seem to contribute in predicting SNM outcome.

Differentiation of lower urinary tract dysfunctions: The role of ambulatory urodynamic monitoring.

OBJECTIVES: To determine the value of ambulatory urodynamic monitoring in the assessment of patients with lower urinary tract symptoms. METHODS: This was a cross-sectional study including patients who underwent both conventional urodynamic and ambulatory urodynamic assessment at our Center between December 2002 and February 2013. The ambulatory urodynamic studies were interpreted in a standardized way by a resident experienced with urodynamic measurements, and one staff member who specialized in incontinence and urodynamics. RESULTS: A total of 239 patients (71 male and 168 female) were included in the present study. The largest subgroup of patients, 79 (33%), underwent ambulatory urodynamic monitoring based on suspicion of an acontractile bladder. However, 66 of these patients (83.5%) still showed contractions on ambulatory urodynamics. Other groups that were analyzed were patients with suspected storage dysfunction (47 patients), inconclusive conventional urodynamic studies (68 patients) and incontinence of unclear origin (45 patients). Particularly in this last group, ambulatory urodynamics appeared to be useful for discrimination between different causes of incontinence. CONCLUSIONS: Ambulatory urodynamic monitoring is a valuable discriminating diagnostic tool in patients with lower urinary tract symptoms who have already undergone conventional urodynamics, particularly in the case of patients with suspected bladder acontractility and incontinence of unclear origin during ambulatory urodynamics. Further study is required to determine the clinical implications of the findings and their relationship with treatment outcome.

Cold-activated brown adipose tissue in healthy men.

BACKGROUND: Studies in animals indicate that brown adipose tissue is important in the regulation of body weight, and it is possible that individual variation in adaptive thermogenesis can be attributed to variations in the amount or activity of brown adipose tissue. Until recently, the presence of brown adipose tissue was thought to be relevant only in small mammals and infants, with negligible physiologic relevance in adult humans. We performed a systematic examination of the presence, distribution, and activity of brown adipose tissue in lean and obese men during exposure to cold temperature. Brown-adipose-tissue activity was studied in relation to body composition and energy metabolism. METHODS: We studied 24 healthy men--10 who were lean (body-mass index [BMI] [the weight in kilograms divided by the square of the height in meters], < 25) and 14 who were overweight or obese (BMI, > or = 25)--under thermoneutral conditions (22 degrees C) and during mild cold exposure (16 degrees C). Putative brown-adipose-tissue activity was determined with the use of integrated (18)F-fluorodeoxyglucose positron-emission tomography and computed tomography. Body composition and energy expenditure were measured with the use of dual-energy x-ray absorptiometry and indirect calorimetry. RESULTS: Brown-adipose-tissue activity was observed in 23 of the 24 subjects (96%) during cold exposure but not under thermoneutral conditions. The activity was significantly lower in the overweight or obese subjects than in the lean subjects (P=0.007). BMI and percentage of body fat both had significant negative correlations with brown adipose tissue, whereas resting metabolic rate had a significant positive correlation. CONCLUSIONS: The percentage of young men with brown adipose tissue is high, but its activity is reduced in men who are overweight or obese. Brown adipose tissue may be metabolically important in men, and the fact that it is reduced yet present in most overweight or obese subjects may make it a target for the treatment of obesity.

Self-consciousness/awareness and bladder sensations: Comparative study of overactive bladder patients and healthy volunteers.

OBJECTIVES: To explore differences in bladder sensations between patients with overactive bladder (OAB) and healthy volunteers by evaluating self-consciousness, self-awareness and affective complaints. METHODS: A prospective, observational study was performed comparing patients with OAB symptoms and healthy volunteers. During 3 days subjects filled out sensation-related bladder diaries (SR-BD), Self-Consciousness Questionnaires (SCS), Self-Awareness Questionnaire (SSAS) and the Hospital Anxiety and Depression Scale (HADS). The SSAS was filled out at the second void of the first day. RESULTS: In total, 134 participants were included (66 volunteers and 68 patients). Patients had lower voided volumes (193 vs 270 mL, P < 0.05), higher urinary frequency (10.6 vs 6.6, P < 0.05) and higher urgency scores (2.0 vs 1.2, P < 0.05) than volunteers, while perceived bladder fullness was similar. The SCS scores were similar, but the SSAS score was significantly higher for OAB patients (53.6 vs 44.6, P < 0.05). OAB Patients had significantly higher scores for anxiety and depression according to the HADS. CONCLUSIONS: There were significant differences in SR-BD between volunteers and OAB patients. OAB patients had significantly higher self-awareness than volunteers, indicating that OAB patients may attribute different values to body signals. Future research is required to elaborate our knowledge on the perceived sensations and labeling of emotions in OAB.

Associations of Psychometric Affective Parameters with Urodynamic Investigation for Urinary Frequency.

OBJECTIVES: To assess an association between affective symptoms and conventional urodynamic results in a pilot study. METHODS: The study represents a retrospective analysis of prospectively obtained clinical data, voiding diaries, urodynamic parameters and Hospital Anxiety and Depression Scale (HADS). RESULTS: A total of 74 patients with urinary frequency attending a multidisciplinary pelvic care centre was included in this study. There was a significant association between the total HADS scores and presence of DO (P = 0.019). In addition, results showed an association between HADS anxiety scores (≥8) and Detrusor Overactivity (DO) (P = 0.018) and between HADS depression scores (≥8) and the feeling of urgency (P = 0.028). Comparative analysis showed differences in age, mean voiding volume, bladder capacity and strong desire between patients with DO and those without. CONCLUSION: This pilot study revealed an association between psychometric parameters and urodynamic results indicating a common pathway of bladder function and affective complaints. Further research is needed to elucidate which parts of the bladder-brain axis are involved and how these parts correspond by means of urodynamics.

Affective symptoms and the overactive bladder - a systematic review.

BACKGROUND: Overactive bladder syndrome (OAB) is characterised by urgency symptoms, with or without urgency incontinence, usually with frequency and nocturia. Although literature suggest an association between OAB, depression and anxiety, no systematic review has been presented. OBJECTIVE: Systematically review the literature on the association of affective conditions with OAB. METHODS: Systematic review according to the PRISMA guidelines. This review is registered in the PROSPERO register (CRD4201400664). RESULTS: Forty-three articles were included, describing more than 80,000 subjects. Depression and OAB were positively associated in 26 studies, anxiety and OAB in 6 studies. Longitudinal studies reported: a) OAB subjects who developed depression/anxiety or b) depressed/anxious subjects developing OAB, or c) both. The quality of evidence in studies reporting an association between the co-occurrence of OAB and depression was rated level 3 in accordance with the GRADE framework. Evidence reporting on the co-occurrence of anxiety and OAB was rated GRADE level 2. Longitudinal associations between new onset of OAB in depressive subjects was GRADE level 2. Evidence reporting association of OAB with anxiety in longitudinal studies was of GRADE level 1. CONCLUSION: To our knowledge, this systematic review is the first to give a comprehensive qualitative overview on the association between OAB and affective symptoms. Many evaluated studies failed to note longitudinal changes and lacked evidence of causality. Still, results revealed an association between OAB and affective symptoms and there is evidence for new onset of OAB in depressive subjects, but further research is necessary to examine the strength of the effect.