Brain Response Induced by Peroneal Electrical Transcutaneous Neuromodulation Invented for Overactive Bladder Treatment, as Detected by Functional Magnetic Resonance Imaging.

OBJECTIVES: In this study, we aimed to investigate whether peroneal electrical Transcutaneous Neuromodulation invented for overactive bladder (OAB) treatment elicits activation in brain regions involved in neural regulation of the lower urinary tract. MATERIALS AND METHODS: Among 22 enrolled healthy female volunteers, 13 were eligible for the final analysis. Functional magnetic resonance imaging (fMRI) (Siemens VIDA 3T; Erlangen, Germany) was used to compare the brain region activation elicited by peroneal electrical Transcutaneous Neuromodulation with the activation elicited by sham stimulation. Each subject underwent brain fMRI recording during eight 30-second periods of rest, alternating with 30-second periods of passive feet movement using the sham device, mimicking the motor response to peroneal nerve stimulation. Subsequently, fMRI recording was performed during the analogic "off-on" stimulation paradigm using peroneal electrical transcutaneous neuromodulation. Magnetic resonance imaging data acquired during both paradigms were compared using individual and group statistics. RESULTS: During both peroneal electrical Transcutaneous Neuromodulation and sham feet movements, we observed activation of the primary motor cortex and supplementary motor area, corresponding to the cortical projection of lower limb movement. During peroneal electrical Transcutaneous Neuromodulation, we observed significant activations in the brain stem, cerebellum, cingulate gyrus, putamen, operculum, and anterior insula, which were not observed during the sham feet movement. CONCLUSIONS: Our study provides evidence that peroneal electrical Transcutaneous Neuromodulation elicits activation of brain structures that have been previously implicated in the perception of bladder fullness and that play a role in the ability to cope with urinary urgency. Our data suggest that neuromodulation at the level of supraspinal control of the lower urinary tract may contribute to the treatment effect of peroneal electrical Transcutaneous Neuromodulation in patients with OAB.

Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder.

PURPOSE: We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary-derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.

Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder.

PURPOSE: The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). METHODS: This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3 months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12 months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. RESULTS: The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12 months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). CONCLUSION: The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12 months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.

Differences between brain responses to peroneal electrical transcutaneous neuromodulation and transcutaneous tibial nerve stimulation, two treatments for overactive bladder.

OBJECTIVES: To compare brain responses to peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) and transcutaneous tibial nerve stimulation (TTNS), two methods for treating overactive bladder (OAB), using functional magnetic resonance imaging (fMRI). The present study was not designed to compare their clinical efficacy. MATERIALS AND METHODS: This study included 32 healthy adult female volunteers (average age 38.3 years (range 22-73)). Brain MRI using 3 T scanner was performed during three 8-min blocks of alternating sequences. During each 8-min block, the protocol alternated between sham stimulation (30 s) and rest (30 s) for 8 repeats; then peroneal eTNM® stimulation (30 s) and rest (30 s) for 8 repeats; then, TTNS stimulation (30 s) and rest (30 s) for 8 repeats. Statistical analysis was performed at the individual level with a threshold of p = 0.05, family-wise error (FWE)-corrected. The resulting individual statistical maps were analyzed in group statistics using a one-sample t-test, p = 0.05 threshold, false discovery rate (FDR)-corrected. RESULTS: During peroneal eTNM®, TTNS, and sham stimulations, we recorded activation in the brainstem, bilateral posterior insula, bilateral precentral gyrus, bilateral postcentral gyrus, left transverse temporal gyrus, and right supramarginal gyrus. During both peroneal eTNM® and TTNS stimulations, but not sham stimulations, we recorded activation in the left cerebellum, right transverse temporal gyrus, right middle frontal gyrus, and right inferior frontal gyrus. Exclusively during peroneal eTNM® stimulation, we observed activation in the right cerebellum, right thalamus, bilateral basal ganglia, bilateral cingulate gyrus, right anterior insula, right central operculum, bilateral supplementary motor cortex, bilateral superior temporal gyrus, and left inferior frontal gyrus. CONCLUSIONS: Peroneal eTNM®, but not TTNS, induces the activation of brain structures that were previously implicated in neural control of the of bladder filling and play an important role in the ability to cope with urgency. The therapeutic effect of peroneal eTNM® could be exerted, at least in part, at the supraspinal level of neural control.

Two-Staged Sacral Neuromodulation for the Treatment of Nonobstructive Urinary Retention: A Multicenter Study Assessing Predictors of Success.

OBJECTIVES: The aims of this study were to 1) determine the success rate of the tined lead test phase in patients with nonobstructive urinary retention (NOUR), 2) determine predictive factors of a successful test phase in patients with NOUR, and 3) determine long-term treatment efficacy and satisfaction in patients with NOUR. MATERIALS AND METHODS: The first part was a multicenter retrospective study at two centers in The Netherlands. Patients with NOUR received a four-week tined lead test phase. Success was defined as a ≥50% reduction of clean intermittent catheterization frequency or postvoid residual. We analyzed possible predictors of success with multivariable logistic regression. Second, all patients received a questionnaire to assess efficacy, perceived health (Patient Global Impression of Improvement), and treatment satisfaction. RESULTS: This study included 215 consecutive patients (82 men and 133 women) who underwent a tined lead test phase for the treatment of NOUR. The success rate in women was significantly higher than in men, respectively 62% (83/133) and 22% (18/82, p < 0.001). In women, age per ten years (odds ratio [OR] 0.74, 95% CI: 0.59-0.93) and a history of psychiatric illness (OR 3.92, 95% CI: 1.51-10.2), including posttraumatic stress disorder (PTSD), significantly predicted first stage sacral neuromodulation (SNM) success. In men, age per ten years (OR 0.43, 95% CI: 0.25-0.72) and previous transurethral resection of the prostate and/or bladder neck incision (OR 7.71, 95% CI: 1.43-41.5) were significant predictors of success. Conversely, inability to void during a urodynamic study (for women, OR 0.79, 95% CI: 0.35-1.78; for men, OR 3.06, 95% CI: 0.83-11.3) was not predictive of success. Of the patients with a successful first stage, 75% (76/101) responded to the questionnaire at a median follow-up of three years. Of these patients, 87% (66/76) continued to use their SNM system, and 92% (70/76) would recommend SNM to other patients. CONCLUSIONS: A history of psychiatric illness, including PTSD, in women with NOUR increased the odds of first stage SNM success 3.92 times. A previous transurethral resection of the prostate and/or bladder neck incision in men increased the odds of success 7.71 times. In addition, a ten-year age increase was associated with an OR of 0.43 in men and 0.74 in women, indicating a 2.3- and 1.3-times decreased odds of success, respectively.

Neurogenic bowel dysfunction score in spinal cord-injured patients: translation and validation of the Dutch-language NBD score.

STUDY DESIGN: This is a prospective validation study. OBJECTIVES: The neurogenic bowel dysfunction (NBD) score is a widely used symptom-based questionnaire evaluating bowel dysfunction and its impact on quality of life (QoL) in spinal cord-injured patients. This study aimed to translate and validate a Dutch-language NBD score in patients with SCI. SETTING: Patients with SCI visiting the urology department or general practitioner (GP) in Rotterdam, the Netherlands. METHODS: Standardized guidelines were followed for the translation and validation process of the NBD score. Adult patients with SCI visiting our urology department were asked to participate by filling in a set of questionnaires: the NBD score, the Fecal Incontinence Quality of Life scale (FIQL), the Fecal Incontinence Severity Index (FISI), and the European Quality of life 5-Dimension 3-Level questionnaire (EQ-5D-3L) at baseline and 1-2 weeks afterward. A control group recruited at a GP office completed the questionnaires once. The following measurement properties were evaluated: content validity, internal consistency, reproducibility, criterion-, and construct validity. RESULTS: Fifty-eight patients and 50 references were included. Content validity was adequate, internal consistency was moderate (Cronbach's alpha 0.56 and 0.30) and reproducibility was adequate (ICC 0.87). Criterion validity was confirmed; NBD score correlated significantly with the FIQL, FISI, and EQ-5D-3L. NBD scores in the patient group were significantly higher than in references, demonstrating good construct validity. CONCLUSIONS: The Dutch-language version of the NBD score showed moderate to good measurement properties, and therefore is a reliable tool to measure bowel dysfunction in patients with SCI. We recommend standardized usage of this questionnaire for clinical evaluation and research purposes.

Kilohertz alternating current neuromodulation of the pudendal nerves: effects on the anal canal and anal sphincter in rats.

The first two objectives were to establish which stimulation parameters of kilohertz frequency alternating current (KHFAC) neuromodulation influence the effectiveness of pudendal nerve block and its safety. The third aim was to determine whether KHFAC neuromodulation of the pudendal nerve can relax the pelvic musculature, including the anal sphincter. Simulation experiments were conducted to establish which parameters can be adjusted to improve the effectiveness and safety of the nerve block. The outcome measures were block threshold (measure of effectiveness) and block threshold charge per phase (measure of safety). In vivo, the pudendal nerves in 11 male and 2 female anesthetized Sprague Dawley rats were stimulated in the range of 10 Hz to 40 kHz, and the effect on anal pressure was measured. The simulations showed that block threshold and block threshold charge per phase depend on waveform, interphase delay, electrode-to-axon distance, interpolar distance, and electrode array orientation. In vivo, the average anal pressure during unilateral KHFAC stimulation was significantly lower than the average peak anal pressure during low-frequency stimulation (p < 0.001). Stimulation with 20 kHz and 40 kHz (square wave, 10 V amplitude, 50% duty cycle, no interphase delay) induced the largest anal pressure decrease during both unilateral and bilateral stimulation. However, no statistically significant differences were detected between the different frequencies. This study showed that waveform, interphase delay and the alignment of the electrode along the nerve affect the effectiveness and safety of KHFAC stimulation. Additionally, we showed that KHFAC neuromodulation of the pudendal nerves with an electrode array effectively reduces anal pressure in rats.

Androgen receptors in areas of the spinal cord and brainstem: A study in adult male cats.

Sex hormones, including androgens and estrogens, play an important role in autonomic, reproductive and sexual behavior. The areas that are important in these behaviors lie within the spinal cord and brainstem. Relevant dysfunctional behavior in patients with altered androgen availability or androgen receptor sensitivity might be explained by the distribution of androgens and their receptors in the central nervous system. We hypothesize that autonomic dysfunction is correlated with the androgen sensitivity of spinal cord and brainstem areas responsible for autonomic functions. In this study, androgen receptor immunoreactive (AR-IR) nuclei in the spinal cord and brainstem were studied using the androgen receptor antibody PG21 in four uncastrated young adult male cats. A dense distribution of AR-IR nuclei was detected in the superior layers of the dorsal horn, including lamina I. Intensely stained nuclei, but less densely distributed, were found in lamina X and preganglionic sympathetic and parasympathetic cells of the intermediolateral cell column. Areas in the caudal brainstem showing a high density of AR-IR nuclei included the area postrema, the dorsal motor vagus nucleus and the retrotrapezoid nucleus. More cranially, the central linear nucleus in the pons contained a dense distribution of AR-IR nuclei. The mesencephalic periaqueductal gray (PAG) showed a dense distribution of AR-IR nuclei apart from the most central part of the PAG directly adjacent to the ependymal lining. Other areas in the mesencephalon with a dense distribution of AR-IR nuclei were the dorsal raphe nucleus, the retrorubral nucleus, the substantia nigra and the ventral tegmental area of Tsai. It is concluded that AR-IR nuclei are located in specific areas of the central nervous system that are involved in the control of sensory function and autonomic behavior. Furthermore, damage of these AR-IR areas might explain related dysfunction in humans.

Trends in the use and costs of intermittent urinary catheters in the Netherlands from 1997 to 2018: A population-based observational study.

AIM: To obtain insight into the the use and costs of clean intermittent catheterization (CIC) in the Netherlands from 1997 to 2018. METHODS: For this population-based study, data on the use and costs of disposable catheters were provided by the Drug Information Project database. This database contains information about the Dutch insured population, which increased from 9.9 to 17.1 million persons between 1997 and 2018 (64%-100% of the Dutch population). The following trends were evaluated: (1) CIC users, (2) distribution of users by gender and age-group, (3) distribution of users by neurogenic and non-neurogenic cause for CIC, (4) total costs, and (5) costs per user. Total users are adjusted for the Dutch population. Costs are corrected for inflation and expressed in euros. RESULTS: Extramural use of CIC increased from 14,258 users in 1997 to 45,909 users in 2018. CIC users per 100,000 persons nearly tripled from 92 users to 267 users. Male CIC users almost quadrupled from 92 to 334 per 100,000 insured persons, whereas female users more than doubled from 91 to 201 per 100,000 insured persons. In 2018, 49% of the users had a non-neurogenic cause for CIC. Total costs increased from 16.4 million euros in 1997 to 74.6 million euros in 2018. Costs per user rose from 1151 to 1624 euros (41.1%). CONCLUSIONS: The use and costs of disposable catheters in the Netherlands increased substantially over the past two decades. Non-neurogenic bladder patients represent 49% of the population on CIC, which has not been described before in the literature.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Recent advances in neuroimaging of bladder, bowel and sexual function.

PURPOSE OF REVIEW: In this review, we summarize recent advances in the understanding of the neural control of the bladder, bowel and sexual function, in both men and women. RECENT FINDINGS: Evidence of supraspinal areas controlling the storage of urine and micturition in animals, such as the pontine micturition centre, emerged in the early 20th century. Neurological stimulation and lesion studies in humans provided additional indirect evidence for additional bladder-related brain areas. Thereafter, functional neuroimaging in humans with PET and fMRI provided more direct evidence of the involvement of these brain areas. The areas involved in the storage and expulsion of urine also seem to be involved in the central control of storage and expulsion of feces. Furthermore, most knowledge on the brain control of sexual function is obtained from dynamic imaging in human volunteers. Relatively little is known about the dysfunctional central circuits in patients with pelvic organ dysfunction. SUMMARY: fMRI has been the most widely used functional neuroimaging technique in the last decade to study the central control of bladder function, anorectal function and sexual function. The studies described in this review show which sensory and motor areas are involved, including cortical and subcortical areas. We propose the existence of a switch-like phenomenon located in the pons controlling micturition, defecation and orgasm.

Acute effect of sacral neuromodulation for treatment of detrusor overactivity on urodynamic parameters.

AIM: The aim of this study is to evaluate the acute effects of sacral neuromodulation (SNM) on various urodynamic parameters. METHODS: Patients with overactive bladder and detrusor overactivity (DO) who were planned for percutaneous nerve evaluation (PNE) were included. Directly after the PNE, a urodynamic study (UDS) was performed. The stimulation was turned off during the first UDS (UDS 1), and during the second filling cycle, stimulation was turned on (UDS 2). The UDS was followed by a test phase of 1 week and the bladder diaries were evaluated during an outpatient clinic visit. Primary outcome measures were the differences in UDS parameter values with SNM off and on. RESULTS: Ten female patients were included in the study and completed the study protocol. Eight patients showed ≥50% improvement of symptoms following a test phase. There were no differences between UDS 1 and UDS 2 in the UDS parameters; bladder volume at first sensation, bladder volume at first DO, highest DO pressure, bladder capacity, maximum flow rate, and pressure at maximum flow rate. DISCUSSION: None of the aforementioned urodynamic parameters was influenced by acute SNM in patients who responded to SNM. To the best of our knowledge, this is the first study investigating the acute effects of SNM on bladder function.

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2-year outcomes. METHODS: A total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow-up visits. Adverse events (AEs) are reported in all implanted subjects. RESULTS: At 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device-related AEs. CONCLUSIONS: The Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device-related AEs. Subjects reported continued satisfaction with their therapy.

Whole brain 7T-fMRI during pelvic floor muscle contraction in male subjects.

AIM: The primary aim of this study is to demonstrate that 7-tesla functional magnetic resonance imaging (7T-fMRI) can visualize the neural representations of the male pelvic floor in the whole brain of a single subject. METHODS: In total, 17 healthy male volunteers (age 20-47) were scanned in a 7T-MRI scanner (Philips Achieva). The scanning protocol consisted of two functional runs using a multiband echo planar imaging sequence and a T1-weighted scan. The subjects executed two motor tasks, one involving consecutive pelvic floor muscle contractions (PFMC) and a control task with tongue movements. RESULTS: In single subjects, results of both tasks were visualized in the cortex, putamen, thalamus, and the cerebellum. Activation was seen during PFMC in the superomedial and inferolateral primary motor cortex (M1), supplementary motor area (SMA), insula, midcingulate gyrus (MCG), putamen, thalamus, and in the anterior and posterior lobes of the cerebellum. During tongue movement, activation was seen in the inferolateral M1, SMA, MCG, putamen, thalamus, and anterior and posterior lobes of the cerebellum. Tongue activation was found in the proximity of, but not overlapping with, the PFMC activation. Connectivity analysis demonstrated differences in neural networks involved in PFMC and tongue movement. CONCLUSION: This study demonstrated that 7T-fMRI can be used to visualize brain areas involved in pelvic floor control in the whole brain of single subjects and defined the specific brain areas involved in PFMC. Distinct differences between brain mechanisms controlling the pelvic floor and tongue movements were demonstrated using connectivity analysis.

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

Outcome and complications of adjustable continence therapy (ProACTTM ) in the treatment of urinary incontinence after transurethral resection of the prostate: A multicenter study.

AIM: To evaluate the outcome of adjustable continence balloons in the treatment of stress urinary incontinence (SUI) after transurethral resection of the prostate (TURP). METHODS: In two tertiary centers, adjustable continence balloons were implanted in 29 patients with post-TURP SUI between 2007 and 2018. Endpoints of this retrospective multicenter study were patient-reported changes in pad count and complications. Dry was defined as no pad or one security pad. RESULTS: Preoperative urinary incontinence was mild in 7 (24%), moderate in 12 (41%), and severe in 10 (35%) patients. The median follow-up duration was 21 (interquartile range [IQR], 11-43) months. Within 30 days postoperatively, a Clavien-Dindo grade less than or equal to II complication occurred in 24% of the patients. Reintervention rate was 24%. Six and 12 months after implantation, the International Prostate Symptom Score (IPSS) quality-of-life item improved significantly from 5 (IQR, 5-6) preoperatively to 3 (IQR, 1-4.5) and 1 (IQR, 0-3), respectively. At last visit (median 21 months after implantation), the outcome on continence had improved in 76% of the patients, including, 45% dry patients. After a median follow-up of 28 months (IQR, 13-63; N = 23), all but one patient reported improvement on the Patient Global Impression of Improvement (PGI-I) scale. In detail, 10 patients reported "very much better" condition compared with before the implantation, 10 patients "much better," two patients "a little better," and one patient "no change." Daily pad use decreased from three (IQR, 2-5) to one (IQR, 0-2) pads/day (P < 0.001). CONCLUSIONS: This is hitherto, the first study reporting results of adjustable continence balloons in the treatment of post-TURP SUI. The therapy was found to be safe and efficient. The majority of our study population reported improvement on their condition and greater than or equal to 50% reduction in daily pad use.

The validation of the Dutch OAB-q SF: An overactive bladder symptom bother and health-related quality of life short-form questionnaire.

AIMS: The overactive bladder quality of life short-form questionnaire (OAB-q SF) evaluates both symptom bother and health-related quality of life in patients with OAB, a highly prevalent disease. The objective of this study was to translate and validate a Dutch version of the OAB-q SF. METHODS: The translation into Dutch and validation process of the OAB-q SF was performed according to standardized guidelines. Patients with OAB who visited the department of Urology outpatient clinic completed the questionnaires OAB-q SF, European Quality of life 5-Dimension 5-Level questionnaire (EQ-5D-5L), Urogenital Distress Inventory 6 (UDI-6), and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) at baseline (test) and 2 weeks later (retest). A reference group from the department of Allergology outpatient clinic completed the same questionnaires once. The evaluated measurement properties included content validity, internal consistency, reproducibility, criterion validity, and construct validity. RESULTS: Fifty-two patients were included in the study group and 51 references were included. The content validity was adequate and the internal consistency was excellent (Cronbach's α > 0.80). The reproducibility was good with intraclass correlation coefficients higher than 0.70. Patient's OAB-q SF scores were moderately to strongly correlated with the UDI-6, ICIQ-OAB, and the EQ-5D-5L confirming the criterion validity. A good construct validity was demonstrated with significant higher scores of the OAB-q SF score in patients compared to references. CONCLUSIONS: The Dutch OAB-q SF is a reliable and valid measure to evaluate symptom bother and health-related quality of life in patients with OAB.

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.

AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.