bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.

OBJECTIVE: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.

Comparison of traditional outcome measures and self-assessed goal achievement in patients treated surgically for benign prostatic hyperplasia.

PURPOSE: To determine self-assessed goal achievement (SAGA) outcomes in men treated surgically for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) and compare them to the traditional outcome measures. METHODS: Single-center analysis of prospective database of men undergoing surgical treatment of LUTS/BPO at a single institution between July 2019 and March 2021. We assessed individual goals, traditional questionnaires, and functional outcomes prior to treatment, and at first follow-up after 6-12 weeks. We compared SAGA outcomes 'overall goal achievement' and 'satisfaction with treatment' to subjective and objective outcomes using Spearman's rank correlations (rho). RESULTS: A total of sixty-eight patients completed the individual goal formulation prior to surgery. Preoperative goals varied between different treatments and individuals. IPSS correlated with 'overall goal achievement' (rho = - 0.78, p < 0.001) and 'satisfaction with treatment' (rho = - 0.59, p < 0.001). Similarly, the IPSS-QoL was correlated with overall goal achievement (rho = - 0.79, p < 0.001) and satisfaction with treatment (rho = - 0.65, p < 0.001). No correlation was seen between SAGA outcomes and functional outcomes Qmax and PVR. CONCLUSIONS: SAGA represents a uniquely patient-specific outcome measure. Our study is, to our knowledge, the first to assess patient-specific goals prior to surgery and examine SAGA outcomes following treatment in men suffering from LUTS/BPO. The correlation of SAGA outcomes with IPSS and IPSS-QoL highlight the importance of this well-established questionnaire. Functional outcomes do not necessarily reflect patient's goals and may rather be considered physician-directed outcomes.

Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction.

BACKGROUND: Neurogenic lower urinary tract dysfunction (NLUTD) is a highly prevalent and disabling condition; nevertheless, standard treatments often remain unsatisfactory. Sacral neuromodulation (SNM) is a well-established therapy for non-NLUTD, but there is a lack of randomized controlled trials to show benefit in patients with NLUTD. METHODS: For this sham-controlled, double-blind, multicenter trial, patients with refractory NLUTD (and intended SNM) were recruited at four Swiss SNM referral centers. After lead placement into the sacral foramina S3 (rarely, S4), all participants underwent SNM testing. If successful (≥50% improvement in key bladder diary variables), the neurostimulator was implanted for permanent stimulation. For 2 months, neuromodulation was optimized using subsensory stimulation with individually adjusted parameters. Thereafter, the neurostimulator remained on or was switched off (1:1 random allocation to group SNM ON or SNM OFF, respectively) for 2 months, followed by a neurourologic reevaluation. The primary outcome was success, as defined above, of SNM compared with baseline. RESULTS: Of 124 patients undergoing SNM testing, 65 (52%) had successfully improved lower urinary tract function. Of these, 60 patients (median age, 49.5 years; 43 women) were randomly assigned to the intervention. After 2 months of intervention, the SNM ON group demonstrated a success rate of 76%. In the SNM OFF group, 42% of patients showed sustained SNM effects despite their neurostimulator being switched off during the last 2 months (odds ratio, 4.35; 95% confidence interval, 1.43 to 13.21; P=0.009). During the entire study period, there were 11 adverse events (6 dropouts; no dropouts during the intervention phase). CONCLUSIONS: SNM effectively corrected refractory NLUTD in the short term in well-selected neurologic patients. (Funded by the Swiss National Science Foundation, Vontobel­Stiftung, Gottfried und Julia Bangerter­Rhyner Stiftung, Dr. Urs Mühlebach, and the Swiss Continence Foundation; ClinicalTrials.gov number, NCT02165774.)

Aquablation versus holmium laser enucleation of the prostate in the treatment of benign prostatic hyperplasia in medium-to-large-sized prostates (ATHLETE): protocol of a prospective randomised trial.

INTRODUCTION: A novel method for the surgical treatment of benign prostatic hyperplasia (BPH) called Aquablation has become commercially available. Previous studies have been able to show similar functional results when compared with transurethral resection of the prostate and a high efficacy has been demonstrated when this approach is applied to patients with a prostate size of 80-150 cm3.Holmium laser enucleation of the prostate (HoLEP) is a well-established procedure in the surgical treatment of BPH in prostate glands larger than 30 mL and a first-line therapy in glands over 80 mL. To date, no data are available whether Aquablation is non-inferior compared with HoLEP in the treatment of patients with medium-to-large-sized prostates regarding safety and efficacy. METHODS AND ANALYSIS: This is a prospective, randomised, open-label, non-inferiority clinical trial conducted at a Swiss centre of tertiary care. The primary outcome is assessment of non-inferiority of Aquablation compared with HoLEP in reducing lower urinary tract symptoms due to benign prostatic obstruction measured by the International Prostate Symptom Score (IPSS). Randomisation will be performed using secuTrial, stratifying on age (<70 years, 70+ years) and prostate volume (<100 mL, 100+ mL). Both interventions are performed in an inpatient setting and regular follow-up controls starting 8 weeks after intervention and continuing up to 5 years will be performed. The primary outcome (change in IPSS from baseline to 6 months) will be tested for non-inferiority with a one-sided t-test. Secondary outcomes, such as efficacy parameters, several patient-reported outcome measures, and periprocedural and safety parameters will be described by calculating means or relative frequencies for each treatment group and testing differences with two-sided standard superiority tests. ETHICS AND DISSEMINATION: The study was approved by the local ethics committee (EKOS 2020-02353). Results of the primary endpoint and each of the secondary endpoints will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04560907).

Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial.

BACKGROUND: Prostatic artery embolisation (PAE) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (LUTS/BPO) still remains under investigation. OBJECTIVE: To compare the efficacy and safety of PAE and transurethral resection of the prostate (TURP) in the treatment of LUTS/BPO at 2 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A randomised, open-label trial was conducted. There were 103 participants aged ≥40 yr with refractory LUTS/BPO. INTERVENTION: PAE versus TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: International Prostate Symptoms Score (IPSS) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated. Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests. RESULTS AND LIMITATIONS: The mean reduction in IPSS after 2 yr was 9.21 points after PAE and 12.09 points after TURP (difference of 2.88 [95% confidence interval 0.04-5.72]; p = 0.047). Superiority of TURP was also found for most other patient-reported outcomes except for erectile function. PAE was less effective than TURP regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31-240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70-31.38]; p = 0.005). Adverse events were less frequent after PAE than after TURP (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar. Ten patients (21%) who initially underwent PAE required TURP within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and, therefore, represents a limitation of the study. CONCLUSIONS: Inferior improvements in LUTS/BPO and a relevant re-treatment rate are found 2 yr after PAE compared with TURP. PAE is associated with fewer complications than TURP. The disadvantages of PAE regarding functional outcomes should be considered for patient selection and counselling. PATIENT SUMMARY: Prostatic artery embolisation is safe and effective. However, compared with transurethral resection of the prostate, its disadvantages regarding subjective and objective outcomes should be considered for individual treatment choices.

Benefits and Harms of Electrical Neuromodulation for Chronic Pelvic Pain: A Systematic Review.

CONTEXT: Patients with chronic pelvic pain (CPP) may have pain refractory to conventional pain management strategies. Neuromodulation could provide relief of pain. OBJECTIVE: To evaluate the benefits and harms of neuromodulation for CPP. EVIDENCE ACQUISITION: A comprehensive search of EMBASE, PUBMED, and SCOPUS was performed for the entire database to January 2018. Studies were selected, data were extracted, and quality was assessed by two independent reviewers. A meta-analysis was used to combine randomized controlled trials (RCTs); otherwise, a narrative analysis was used. EVIDENCE SYNTHESIS: After screening 1311 abstracts, 36 studies including eight RCTs were identified, enrolling 1099 patients. Studies covered a broad range in terms of phenotypes of CPP and methods of neuromodulation. A meta-analysis was possible for percutaneous tibial nerve stimulation and transcutaneous electrical nerve stimulation, which showed improvement in pain. Only narrative synthesis was possible for other modalities (sacral nerve stimulation, spinal cord stimulation, intravaginal electrical stimulation, and pudendal nerve stimulation) which appeared to reduce pain in patients with CPP. Treatments generally improved quality of life but with variable reporting of adverse events. Many studies showed high risks of bias and confounding. CONCLUSIONS: While electrical neuromodulation may improve symptoms in CPP, further work is needed with high-quality studies to confirm it. PATIENT SUMMARY: Neuromodulation may be useful in reducing pain and improving quality of life in patients with chronic pelvic pain, but more research is needed.

In-hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial.

OBJECTIVES: To perform a post hoc analysis of in-hospital costs incurred in a randomized controlled trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). PATIENTS AND METHODS: In-hospital costs arising from PAE and TURP were calculated using detailed expenditure reports provided by the hospital accounts department. Total costs, including those arising from surgical and interventional procedures, consumables, personnel and accommodation, were analysed for all of the study participants and compared between PAE and TURP using descriptive analysis and two-sided t-tests, adjusted for unequal variance within groups (Welch t-test). RESULTS: The mean total costs per patient (±sd) were higher for TURP, at €9137 ± 3301, than for PAE, at €8185 ± 1630. The mean difference of €952 was not statistically significant (P = 0.07). While the mean procedural costs were significantly higher for PAE (mean difference €623 [P = 0.009]), costs apart from the procedure were significantly lower for PAE, with a mean difference of €1627 (P < 0.001). Procedural costs of €1433 ± 552 for TURP were mainly incurred by anaesthesia, whereas €2590 ± 628 for medical supplies were the main cost factor for PAE. CONCLUSIONS: Since in-hospital costs are similar but PAE and TURP have different efficacy and safety profiles, the patient's clinical condition and expectations - rather than finances - should be taken into account when deciding between PAE and TURP.

Is absorption of irrigation fluid a problem in Thulium laser vaporization of the prostate? A prospective investigation using the expired breath ethanol test.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men. If medical treatment fails, monopolar transurethral resection of the prostate (TUR-P) is still considered as the standard treatment. The proportion of high-risk patients with cardiac comorbidities increases and TUR-P goes along with a relevant perioperative risk. Especially large volume influx of irrigation fluid and transurethral resection syndrome (TUR syndrome) represent serious threats to these patients. Using isotonic saline as irrigation fluid like in transurethral laser vaporization (TUV-P), TUR syndrome can be prevented. However, no prospective trial has ever assessed occurrence or extent of irrigation fluid absorption in Thulium Laser TUV-P. METHODS/DESIGN: This is a single-center prospective trial, investigating, if absorption of irrigation fluid occurs during Thulium Laser TUV-P by expired breath ethanol test. The expired breath ethanol technique is an established method of investigating intraoperative absorption of irrigation fluid: A tracer amount of ethanol is added to the irrigation fluid and the absorption of irrigation fluid can be calculated by measuring the expiratory ethanol concentrations of the patient with an alcohol breathalyzer. Fifty consecutive patients undergoing TUV-P at our tertiary referral center are included into the trial. Absorption volume of irrigation fluid during Thulium Laser TUV-P is defined as primary endpoint. Pre- to postoperative changes in bladder diaries, biochemical and hematological laboratory findings, duration of operation and standardized questionnaires are assessed as secondary outcome measures. DISCUSSION: The aim of this study is to assess the safety of Thulium Laser TUV-P in regard to absorption of irrigation fluid.

Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men and transurethral resection of the prostate (TURP) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity. Recently, prostatic artery embolization (PAE) was described as a novel effective and less invasive treatment alternative. Despite promising first results, PAE still has to be considered experimental due to a lack of good quality studies. Prospective randomized controlled trials comparing PAE with TUR-P are highly warranted. METHODS/DESIGN: This is a single-centre, prospective, randomized, non-inferiority trial comparing treatment effects and adverse events of PAE and TURP in a tertiary referral centre. One hundred patients who are electable for both treatment options are randomized to either PAE or TURP. Changes of the International Prostate Symptom Score (IPSS) after 3 months are defined as primary endpoint. Changes in bladder diaries, laboratory analyses, urodynamic investigations and standardised questionnaires are assessed as secondary outcome measures. In addition contrast-enhanced magnetic resonance imaging of the pelvis before and after the interventions will provide crucial information regarding morphological changes and vascularisation of the prostate. Adverse events will be assessed on every follow-up visit in both treatment arms according to the National Cancer Institute Common Terminology Criteria for Adverse events and the Clavien classification. DISCUSSION: The aim of this study is to assess whether PAE represents a valid treatment alternative to TURP in patients suffering from BPH in terms of efficacy and safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT02054013.

Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

BACKGROUND: Sacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials. METHODS AND DESIGN: This study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation. DISCUSSION: It is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction. TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov; Identifier: NCT02165774.

The 2013 EAU guidelines on chronic pelvic pain: is management of chronic pelvic pain a habit, a philosophy, or a science? 10 years of development.

CONTEXT: Progress in the science of pain has led pain specialists to move away from an organ-centred understanding of pain located in the pelvis to an understanding based on the mechanism of pain and integrating, as far as possible, psychological, social, and sexual dimensions of the problem. This change is reflected in all areas, from taxonomy through treatment. However, deciding what is adequate investigation to rule out treatable disease before moving to this way of engaging with the patient experiencing pain is a complex process, informed by pain expertise as much as by organ-based medical knowledge. OBJECTIVE: To summarise the evolving changes in the management of patients with chronic pelvic pain by referring to the 2012 version of the European Association of Urology (EAU) guidelines on chronic pelvic pain. EVIDENCE ACQUISITION: The working panel highlights some of the most important aspects of the management of patients with chronic pelvic pain emerging in recent years in the context of the EAU guidelines on chronic pelvic pain. The guidelines were completely updated in 2012 based on a systematic review of the literature from online databases from 1995 to 2011. According to this review, levels of evidence and grades of recommendation were added to the text. A full version of the guidelines is available at the EAU office or Web site (www.uroweb.org). EVIDENCE SYNTHESIS: The previously mentioned issues are explored in this paper, which refers throughout to dilemmas for the physician and treatment team as well as to the need to inform and engage the patient in a collaborative empirical approach to pain relief and rehabilitation. These issues are exemplified in two case histories. CONCLUSIONS: Chronic pelvic pain persisting after appropriate treatment requires a different approach focussing on pain. This approach integrates the medical, psychosocial, and sexual elements of care to engage the patient in a collaborative journey towards self-management.

Bipolar versus monopolar transurethral resection of the prostate: results of a comparative, prospective bicenter study--perioperative outcome and long-term efficacy.

OBJECTIVES: To compare bipolar and monopolar transurethral resection of the prostate (TURP) in a comparative prospective study at two urology centers. METHODS: Of 212 patients with symptomatic benign prostatic hyperplasia entered prospectively into the study, 111 underwent bipolar and 101 monopolar TURP. Patients were treated in two consecutive series with each surgical method at both centers. Improvement in peak flow rate, postvoid residual, International Prostate Symptom Score, and quality of life score postoperatively and at 3, 12, 24 and 36 months, as well as long-term adverse events were compared. Regarding safety, duration of surgery, postoperative catheterization and hospitalization time, amount of fluid absorption, frequency of transurethral resection (TUR) syndrome, and risk of hemorrhage were evaluated. RESULTS: Patient characteristics of the two series were comparable. The risk of developing TUR syndrome (p = 0.32) and bleeding tendency (p = 0.52) did not differ significantly between groups. Significant differences were seen for duration of surgery and resection speed. All functional parameters improved significantly during follow-up, with no relevant differences between surgical groups. CONCLUSIONS: Since no major differences in efficacy and safety were seen between the surgical groups, we feel that the monopolar technique still has a valuable place in TURP.

Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis.

CONTEXT: Treatment of neurogenic lower urinary tract dysfunction (LUTD) is a challenge, because conventional therapies often fail. Sacral neuromodulation (SNM) has become a well-established therapy for refractory non-neurogenic LUTD, but its value in patients with a neurologic cause is unclear. OBJECTIVE: To assess the efficacy and safety of SNM for neurogenic LUTD. EVIDENCE ACQUISITION: Studies were identified by electronic search of PubMed, EMBASE, and ScienceDirect (on 15 April 2010) and hand search of reference lists and review articles. SNM articles were included if they reported on efficacy and/or safety of tested and/or permanently implanted patients suffering from neurogenic LUTD. Two reviewers independently selected studies and extracted data. Study estimates were pooled using Bayesian random-effects meta-analysis. EVIDENCE SYNTHESIS: Of the 26 independent studies (357 patients) included, the evidence level ranged from 2b to 4 according to the Oxford Centre for Evidence-Based Medicine. Half (n=13) of the included studies reported data on both test phase and permanent SNM; the remaining studies were confined to test phase (n=4) or permanent SNM (n=9). The pooled success rate was 68% for the test phase (95% credibility interval [CrI], 50-87) and 92% (95% CrI, 81-98%) for permanent SNM, with a mean follow-up of 26 mo. The pooled adverse event rate was 0% (95% CrI, 0-2%) for the test phase and 24% (95% CrI, 6-48%) for permanent SNM. CONCLUSIONS: There is evidence indicating that SNM may be effective and safe for the treatment of patients with neurogenic LUTD. However, the number of investigated patients is low with high between-study heterogeneity, and there is a lack of randomised, controlled trials. Thus, well-designed, adequately powered studies are urgently needed before more widespread use of SNM for neurogenic LUTD can be recommended.

Subcutaneous tunneling of the temporary testing electrode significantly improves the success rate of subchronic sacral nerve modulation (SNM).

Sacral nerve modulation (SNM) is an effective way to treat non-neurogenic dysfunctions of pelvic organs. For over 20 years, this technique has been used for the treatment of overactive bladder, urinary retention, pelvic pain and even more recently, fecal incontinence and constipation. The objective of the study is to improve the fixation of the temporary testing electrode (TTE) in order to obtain more reliable results in the testing phase which should lead to have a comparable success rate as the two-stage implant for a chronic implant. Twenty-eight patients (ratio of sex women:men = 3:1; with overactive bladder, urinary retention, pelvic pain syndrome and fecal incontinence) were evaluated by the modified temporary test electrode (TTE) placement. With the subcutaneous tunneling technique (mean time of evaluation 8.3 days), it is possible to perform percutaneous nerve evaluation (PNE) more effectively with an objective, reliable and less expensive outcome prior to the implantation of the implantable sacral nerve stimulator in almost 80% of the evaluated patients. Because the costs of therapy are not covered by health insurance in all countries, there is a need for an effective and inexpensive way to test and select patients appropriately. The tunneled TTE maintains its place for consistent amplitude during the entire test duration. The modification of placing the TTE produces repayable results. This technique can be performed on an outpatient basis to evaluate sacral nerve modulation as an early treatment option for non-dysfunctions of pelvic organs before they are forwarded to a specialized center for a chronic SNM implantation.

Sacral neuromodulation for refractory lower urinary tract dysfunction: results of a nationwide registry in Switzerland.

OBJECTIVE: To assess the efficacy and safety of sacral neuromodulation (SNM) in patients with refractory lower urinary tract dysfunction in Switzerland based on a nationwide registry. PATIENTS AND METHODS: A total of 209 patients (181 females, 28 males) underwent SNM testing between July 2000 and December 2005 in Switzerland. Subjective symptom improvement, bladder/pain diary variables, adverse events, and their management were prospectively registered. RESULTS: SNM testing was successful (defined as improvement of more than 50% in bladder/pain diary variables) in 102 of 209 patients (49%). An implantable pulse generator (IPG) was placed in 91 patients (89% of all successfully tested and 44% of all tested patients). Of the IPG-implanted patients, 71 had urge incontinence, 13 nonobstructive chronic urinary retention, and 7 chronic pelvic pain syndrome. After a median follow-up of 24 mo, SNM was successful in 64 of the 91 IPG-implanted patients (70%) but failed in 27 patients. SNM was continued in 15 of the 27 patients considered failures, because following troubleshooting SNM response improved subjectively and the patients were satisfied. However, improvement in bladder/pain diary variables remained less than 50%. In the other 12 patients both the leads and the IPG were explanted. During the test phase and during/following IPG implantation, 6% (12 of 209) and 11% (10 of 91) adverse event rates and 1% (3 of 209) and 7% (6 of 91) surgical revision rates were reported, respectively. CONCLUSIONS: SNM is an effective and safe treatment for refractory lower urinary tract dysfunction. Adverse events are usually transient and can be treated effectively.