A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Response to tibial and sacral nerve modulation in overactive bladder: Is there any correlation?

OBJECTIVES: To assess the correlation between the response to transcutaneous tibial nerve stimulation (TTNS) and subsequent response to sacral nerve modulation (SNM) to treat overactive bladder (OAB). MATERIALS AND METHODS: All patients who consecutively received TTNS followed by a two-stage SNM between January 2016 and June 2022 to treat OAB in two university hospital centers were included. The response to each therapy was evaluated with success defined by a 50% or greater improvement in one or more bothersome urinary symptoms from baseline. The primary endpoint was the statistical relationship between the response to TTNS and the response to SNM, assessed by logistic regression. Secondary endpoints were the statistical relationship between the response to TTNS and the response to SNM when controlling for gender, age (<57 years vs. >57 years), presence of an underlying neurological disease, and presence of DO, adding the factor and interaction to the previous regression model. RESULTS: Among the 92 patients enrolled in the study, 68 of them were women (73.9%), and the median age was 57.0 [41.0-69.0] years. The success was reported in 22 patients (23.9%) under TTNS and 66 patients (71.7%) during the SNM test phase. There was no statistical correlation between response to TTNS and response to SNM in the overall population (confidence interval: 95% [0.48-4.47], p = 0.51). Similarly, there was no statistical correlation when controlling for age <57 years or ≥57 years, with p = 1.0 and p = 0.69, respectively. No statistical study could be conducted for the other subpopulations due to small sample sizes. CONCLUSION: The response to TTNS does not predict the response to SNM in the treatment of OAB. TTNS and SNM should be considered as separate therapies, and the decision-making process for OAB treatment should take this into account.

Development of a predictive tool for sacral nerve modulation implantation in the treatment of non-obstructive urinary retention and/or slow urinary stream: a study from the Neuro-Urology Committee of the French Association of Urology.

PURPOSE: This study aimed to seek predictive factors and develop a predictive tool for sacral nerve modulation (SNM) implantation in patients with non-obstructive urinary retention and/or slow urinary stream (NOUR/SS). METHODS: This study was designed as a retrospective study including all patients who have undergone a two-stage SNM for NOUR/SS between 2000 and 2021 in 11 academic hospitals. The primary outcome was defined as the implantation rate. Secondary outcomes included changes in bladder emptying parameters. Univariate and multivariable logistic regression analysis were performed and determined odds ratio for IPG implantation to build a predictive tool. The performance of the multivariable model discrimination was evaluated using the c-statistics and an internal validation was performed using bootstrap resampling. RESULTS: Of the 357 patients included, 210 (58.8%) were finally implanted. After multivariable logistic regression, 4 predictive factors were found, including age (≤ 52 yo; OR = 3.31 CI95% [1.79; 6.14]), gender (female; OR = 2.62 CI95% [1.39; 4.92]), maximal urethral closure pressure (≥ 70 cmH2O; OR: 2.36 CI95% [1.17; 4.74]), and the absence of an underlying neurological disease affecting the lower motor neuron (OR = 2.25 CI95% [1.07; 4.76]). Combining these factors, we established 16 response profiles with distinct IPG implantation rates, ranging from 8.7 to 81.5%. Internal validation found a good discrimination value (c-statistic, 0.724; 95% CI 0.660-0.789) with a low optimism bias (0.013). This allowed us to develop a predictive tool ( https://predictivetool.wixsite.com/void ). CONCLUSION: The present study identified 4 predictive factors, allowing to develop a predictive tool for SNM implantation in NOUR/SS patients, that may help in guiding therapeutic decision-making. External validation of the tool is warranted.

First-Year Experience of Managing Urology Patients With Home Uroflowmetry: Descriptive Retrospective Analysis.

BACKGROUND: Lower urinary tract symptoms affect a large number of people of all ages and sexes. The clinical assessment typically involves a bladder diary and uroflowmetry test. Conventional paper-based diaries are affected by low patient compliance, whereas in-clinic uroflowmetry measurement face challenges such as patient stress and inconvenience factors. Home uroflowmetry and automated bladder diaries are believed to overcome these limitations. OBJECTIVE: In this study, we present our first-year experience of managing urological patients using Minze homeflow, which combines home uroflowmetry and automated bladder diaries. Our objective was 2-fold: first, to provide a description of the reasons for using homeflow and second, to compare the data obtained from homeflow with the data obtained from in-clinic uroflowmetry (hospiflow). METHODS: A descriptive retrospective analysis was conducted using Minze homeflow between July 2019 and July 2020 at a tertiary university hospital. The device comprises a Bluetooth-connected gravimetric uroflowmeter, a patient smartphone app, and a cloud-based clinician portal. Descriptive statistics, Bland-Altman plots, the McNemar test, and the Wilcoxon signed rank test were used for data analysis. RESULTS: The device was offered to 166 patients, including 91 pediatric and 75 adult patients. In total, 3214 homeflows and 129 hospiflows were recorded. Homeflow proved valuable for diagnosis, particularly in cases where hospiflow was unreliable or unsuccessful, especially in young children. It confirmed or excluded abnormal hospiflow results and provided comprehensive data with multiple measurements taken at various bladder volumes, urge levels, and times of the day. As a result, we found that approximately one-fourth of the patients with abnormal flow curves in the clinic had normal bell-shaped flow curves at home. Furthermore, homeflow offers the advantage of providing an individual's plot of maximum flow rate (Q-max) versus voided volume as well as an average or median result. Our findings revealed that a considerable percentage of patients (22/76, 29% for pediatric patients and 24/50, 48% for adult patients) had a Q-max measurement from hospiflow falling outside the range of homeflow measurements. This discrepancy may be attributed to the unnatural nature of the hospiflow test, resulting in nonrepresentative uroflow curves and an underestimation of Q-max, as confirmed by the Bland-Altman plot analysis. The mean difference for Q-max was -3.1 mL/s (with an upper limit of agreement of 13 mL/s and a lower limit of agreement of -19.2 mL/s), which was statistically significant (Wilcoxon signed rank test: V=2019.5; P<.001). Given its enhanced reliability, homeflow serves as a valuable tool not only for diagnosis but also for follow-up, allowing for the evaluation of treatment effectiveness and home monitoring of postoperative and recurrent interventions. CONCLUSIONS: Our first-year experience with Minze homeflow demonstrated its feasibility and usefulness in the diagnosis and follow-up of various patient categories. Homeflow provided more reliable and comprehensive voiding data compared with hospiflow.

The effect of tranexamic acid on perioperative blood loss in transurethral resection of the prostate: A double-blind, randomized controlled trial.

BACKGROUND: Bleeding and bleeding-related complications remain common after bipolar transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. This may possibly lead to prolonged postoperative irrigation, catheterization, and hospital stay. The objective of this trial was to evaluate the effect of high-dose tranexamic acid (TXA) on perioperative blood loss in patients treated with bipolar TURP for prostate sizes between 30 and 80 g. METHODS: We conducted a single-center, prospective, double-blind, randomized controlled trial. Eighty patients were screened for inclusion between March 2020 and January 2023. After exclusion, 65 patients were randomized in two comparable groups. The TXA group (31 patients) received a TXA intravenous loading dose of 10 mg/kg over 30 min before induction, followed by a maintenance dose of 5 mg/kg/h over 12 h. The placebo group (34 patients) received an equal dose of saline infusion. We measured age, weight, preoperative prostate size, anticoagulant use, 5-alpha reductase inhibitor use, preoperative urinary tract infection, American Society of Anesthesiologists score, difference in pre- and 24 h postoperative hemoglobin and hematocrit levels, operative time, resected adenoma weight, duration of postoperative irrigation, total amount of postoperative irrigation fluid, indwelling catheter time, duration of hospital stay, blood transfusion rate, and 4-week complication rate. RESULTS: Baseline characteristics in both groups were comparable. Postoperative hemoglobin decrease in TXA versus placebo group was 1 versus 1.6 mg/dL, respectively (p = 0.04). In addition, the amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups. CONCLUSIONS: Perioperative high-dose TXA seems beneficial in reducing hemoglobin loss, postoperative irrigation, catheterization time, and hospital stay in bipolar TURP for prostate sizes between 30 and 80 g, without increased risk of TXA-related thromboembolic events.

Review of vasocutaneous fistulas and other rare complications after vasectomy.

Introduction: Vasectomy is a surgical procedure for male sterilization. It is a very common procedure in daily urological practice with a low complication rate. Haematoma formation, wound infection, chronic scrotal pain, and spontaneous recanalization are well-known complications. Fistula formation and testicular infarction are less common following a vasectomy. In this article we provide a review of literature regarding rare complications after vasectomy. Material and methods: A manual electronic search of the PubMed Medline and Web of Science Core Collection databases was performed encompassing all included reports until 30 September 2022 to identify studies that assessed patient complications after a vasectomy. Results: Urethrovasocutaneous fistulas are by far the most prevalent, while vasocutaneous, vasovenous, and arteriovenous fistulas are seldom reported. In discharging fistulas, a fluid analysis can be done to discriminate different types. In all cases scrotal exploration and ligation of the fistula was performed. If present, an underlying bladder outlet obstruction should be treated. Scrotal infarction is another infrequently reported complication of vasectomy. Diagnosis is made by scrotal ultrasound and colour Doppler. Treatment is usually conservative, but orchiectomy should be considered in larger infarctions. Simple wound infections are common in patients post vasectomy. More complex infections are rare but can result in serious and even fatal complications. Conclusions: Common complications after vasectomy are well known and usually well discussed with patients. However, rare complications can occur, and it is important that they are recognized by clinicians.

Protein Biomarker Discovery Studies on Urinary sEV Fractions Separated with UF-SEC for the First Diagnosis and Detection of Recurrence in Bladder Cancer Patients.

Urinary extracellular vesicles (EVs) are an attractive source of bladder cancer biomarkers. Here, a protein biomarker discovery study was performed on the protein content of small urinary EVs (sEVs) to identify possible biomarkers for the primary diagnosis and recurrence of non-muscle-invasive bladder cancer (NMIBC). The sEVs were isolated by ultrafiltration (UF) in combination with size-exclusion chromatography (SEC). The first part of the study compared healthy individuals with NMIBC patients with a primary diagnosis. The second part compared tumor-free patients with patients with a recurrent NMIBC diagnosis. The separated sEVs were in the size range of 40 to 200 nm. Based on manually curated high quality mass spectrometry (MS) data, the statistical analysis revealed 69 proteins that were differentially expressed in these sEV fractions of patients with a first bladder cancer tumor vs. an age- and gender-matched healthy control group. When the discriminating power between healthy individuals and first diagnosis patients is taken into account, the biomarkers with the most potential are MASP2, C3, A2M, CHMP2A and NHE-RF1. Additionally, two proteins (HBB and HBA1) were differentially expressed between bladder cancer patients with a recurrent diagnosis vs. tumor-free samples of bladder cancer patients, but their biological relevance is very limited.

The effect of prolapse surgery on voiding function.

INTRODUCTION AND HYPOTHESIS: Of women with symptomatic prolapse, 13-39% experience voiding dysfunction (VD). The aim of our observational cohort study was to determine the effect of prolapse surgery on voiding function. METHODS: Retrospective analysis of 392 women who underwent surgery between May 2005 and August 2020. All had a standardized interview, POP-Q, uroflowmetry and 3D/4D transperineal ultrasound (TPUS) pre-and postoperatively. Primary outcome was change in VD symptoms. Secondary outcomes were changes in maximum urinary flow rate (MFR) centile and post-void residual urine (PVR). Explanatory measures were change in pelvic organ descent as seen on POP-Q and TPUS. RESULTS: Of 392 women, 81 were excluded due to missing data, leaving 311. Mean age and BMI were 58 years and 30 kg/m2, respectively. Procedures performed included anterior repair (n = 187, 60.1%), posterior repair (n = 245, 78.8%), vaginal hysterectomy (n = 85, 27.3%), sacrospinous colpopexy (n = 170, 54.7%) and mid-urethral sling (MUS) (n = 192, 61.7%). Mean follow-up was 7 (1-61) months. Pre-operatively, 135 (43.3%) women reported symptoms of VD. Postoperatively, this decreased to 69 (22.2%) (p < 0.001), and of those, 32 (10.3%) reported de novo VD. The difference remained significant after excluding concomitant MUS surgery (n = 119, p < 0.001). Postoperatively, there was a significant decrease in mean PVR (n = 311, p < 0.001). After excluding concomitant MUS surgery, there was a significant increase in mean MFR centile (p = 0.046). CONCLUSIONS: Prolapse repair significantly reduces symptoms of VD and improves PVR and flowmetry.

Does Cystocele Type Vary Between Vaginally Parous and Nulliparous Women?

OBJECTIVES: To evaluate whether cystocele type varies with vaginal parity. METHODS: Retrospective analysis of 464 vaginally nulliparous women seen at 2 urogynecology units between November 2006 and November 2019. A control group consisted of 871 vaginally parous women seen between July 2017 and November 2019. Patients underwent a standardized interview, POPQ, urodynamic testing, and translabial ultrasound. On imaging, significant cystocele was defined as bladder descent to ≥10 mm below symphysis pubis. Volume datasets were analyzed offline and blinded against clinical data. RESULTS: Of 5266 women seen during the inclusion period, 464 were vaginally nulliparous. Three were excluded due to missing data, leaving 461. A control group of 871 parous women was generated from patients seen during the last 2.5 years of the inclusion period. Vaginally nulliparous women were presented at a younger age compared to vaginally parous women (P < .001). Symptoms of prolapse were reported in 104 (22%) nulliparae and 489 (56%) parous women (P < .0001). Vaginally parous women demonstrated more bladder descent (P < .0001) and more cystocele (418/871 versus 43/461, P < .0001), with a higher proportion of type III cystocele (cystocele with intact retrovesical angle) (20/43 versus 273/ 418, P < .0001). Cystourethrocele (Green type II) was more common in nulliparae and cystocele type III in parous women (P = .015). On multivariate analysis, these differences in proportions remained significant (P = .049). CONCLUSIONS: Nulliparity was associated with a higher proportion of Green type II cystoceles. Green type III cystocele was more common in vaginally parous women, suggesting that the latter may be more likely to be due to childbirth-related pelvic floor trauma.

Detailed Investigation of Bladder Diary Parameters During Sacral Neuromodulation in Patients With Overactive Symptoms.

AIMS: Sacral neuromodulation (SNM) is a well-accepted, minimally invasive modality for patients with overactive bladder (OAB). Successful response to SNM is defined as at least 50% improvement in key symptoms, evaluated in a bladder diary (BD). BDs provide much useful information on bladder behavior during daily life. The aim of this study is to investigate BD parameter changes during SNM therapy in patients with OAB. MATERIALS AND METHODS: The International Consultation on Incontinence Questionnaires (ICIQ)-BD was filled out by 34 patients with OAB, for three days at baseline and after three weeks of subthreshold sensory stimulation. The patients were considered responders for SNM when 50% improvement was seen in the BD. They underwent implantation of an internal pulse generator (IPG), and subsequently, an ICIQ-BD and a visual analog scale (VAS) evaluating bladder satisfaction during three days were filled out six weeks, six months, and one year after IPG implantation. RESULTS: IPGs were implanted in 29 patients (85%). The BD showed a significant decrease in 24-hour leakage at three weeks from 4.2 to 0.6 (-86%, p < 0.001), similar significant decreases at six weeks and six months, and at one year (-80%). Voided volume (VV) at corresponding bladder sensation codes was not different between baseline and at three weeks of tined-lead procedure (TLP) (p > 0.05), and at six weeks (p > 0.05), six months (p > 0.1), and one year of IPG (p > 0.08). After three weeks of TLP, urgency episodes decreased from 4.8 to 3.4 (-30%, p = 0.025), with 59% reduction at six-weeks IPG (p < 0.001) and 49% at six-months IPG (p = 0.013). At one year, a decrease from 4.7 to 2.3 (52% reduction, p = 0.017) was noted. VAS showed the strongest correlation with urgency (p < 0.001) and frequency (p = 0.006). No significant correlation was found with VV (p = 0.87). CONCLUSIONS: Our study describes how bladder sensation parameters change over time in patients on SNM. VV does not significantly increase, nor does frequency significantly decrease over the first year. Leaks and the percentage of urgency episodes significantly decrease, reaching a plateau level between six-weeks and six-months SNM.

Evolution of testicular asymmetry during puberty in adolescents without and with a left varicocele.

OBJECTIVES: To assess the evolution of the Testicular Atrophy Index (TAI) in adolescent boys with and without a left varicocele with special attention for the currently postulated cut-off value of 20%. SUBJECTS AND METHODS: During 2015-2019, 364 adolescent boys aged 11-16 years were recruited. Genital examination and scrotal ultrasonography were repeatedly performed (≥4 month intervals). Testicular volume (TV) was calculated using the Lambert formula (length × width × height × 0.71). TAI was calculated using the formula: [(TVright - TVleft)/TVlargest (right, left)] × 100. RESULTS: The final study population comprised 239 participants, 161 (67.36%) controls and 78 (32.64%) adolescent boys with left varicocele. The mean (sd) number of measurements per participant was 3.82 (1.08). A TAI of ≥20% at first measurement occurred in 9.94% and 35.90%, respectively. Of these, only 31.25% and 46.43% had a TAI of ≥20% at the last measurement, respectively. Nevertheless, the risk of ending up with a TAI of ≥20% was significantly higher if a TAI of ≥20% was recorded at first measurement (P = 0.041 and P = 0.002, respectively). The normalisation rate did not differ significantly between the groups (P = 0.182). Normalisation occurred most frequently in Tanner Stages III and IV. Normalisation was mostly (≥74%) due to catch-up growth of the left testis, in contrast to growth retardation of the right testis, in both groups. The TAI seems to be a fluctuating parameter. CONCLUSION: A TAI of ≥20% is a phenomenon seen in boys with and without varicocele but is more common in boys with varicocele. Although normalisation of a high TAI is frequently seen, both adolescent boys with and without a left varicocele who have an initial TAI of ≥20% have a higher risk of a TAI of ≥20% in the future. As the TAI is a fluctuating parameter during pubertal development, it's use as indicator for varicocelectomy based on a single measurement during pubertal development is questioned.

Diagnosis and treatment of pudendal and inferior cluneal nerve entrapment syndrome: a narrative review.

AIM: Pudendal and inferior cluneal nerve entrapment can cause a neuropathic pain syndrome in the sensitive areas innervated by these nerves. Diagnosis is challenging and patients often suffer several years before diagnosis is made. The purpose of the review was to inform healthcare workers about this disease and to provide a basis of anatomy and physiopathology, to inform about diagnostic tools and invasive or non-invasive treatment modalities and outcome. METHODS: A description of pudendal and inferior cluneal nerve anatomy is given. Physiopathology for entrapment is explained. Diagnostic criteria are described, and all non-invasive and invasive treatment options are discussed. RESULTS: The Nantes criteria offer a solid basis for diagnosing this rare condition. Treatment should be offered in a pluri-disciplinary setting and consists of avoidance of painful stimuli, physiotherapy, psychotherapy, pharmacological treatment led by tricyclic antidepressants and anticonvulsants. Nerve blocks are efficient at short term and serve mainly as a diagnostic tool. Pulsed radiofrequency (PRF) is described as a successful treatment option for pudendal neuralgia in patients non-responding to non-invasive treatment. If all other treatments fail, surgery can be offered. Different surgical procedures exist but only the open transgluteal approach has proven its efficacy compared to medical treatment. The minimal-invasive ENTRAMI technique offers the possibility to combine nerve release with pudendal neuromodulation. CONCLUSIONS: Pudendal and inferior cluneal nerve entrapment syndrome are a challenge not only for diagnosis but also for treatment. Different non-invasive and invasive treatment options exist and should be offered in a pluri-disciplinary setting.

Randomised Controlled Trials Assessing the Clinical Value of Urodynamic Studies: A Systematic Review and Meta-analysis.

Context: The role of urodynamic studies (UDSs) in the diagnosis of lower urinary tract symptoms (LUTS) is crucial. Although expert statements and guidelines underline their value for clinical decision-making in various clinical settings, the academic debate as to their impact on patient outcomes continues. Objective: To summarise the evidence from all randomised controlled trials assessing the clinical usefulness of UDS in the management of LUTS. Evidence acquisition: For this systematic review, searches were performed without language restrictions in three electronic databases until November 18, 2020. The inclusion criteria were randomised controlled study design and allocation to receive UDS or not prior to any clinical management. Quality assessment was performed by two reviewers independently, using the Cochrane Collaboration's tool for assessing the risk of bias. A random-effect meta-analysis was performed on the uniformly reported outcome parameters. Evidence synthesis: Eight trials were included, and all but two focused on women with pure or predominant stress urinary incontinence (SUI). A meta-analysis of six studies including 942 female patients was possible for treatment success, as defined by the authors (relative risk 1.00, 95% confidence interval: 0.93-1.07), indicating no difference in efficacy when managing women with UDS. Conclusions: Although UDSs are not replaceable in diagnostics, since there is no other equivalent method to find out exactly what the lower urinary tract problem is, there are little data supporting its impact on outcomes. Randomised controlled trials have focussed on a small group of women with uncomplicated SUI and showed no added value, but these findings cannot be extrapolated to the overall patient population with LUTS, warranting further well-designed trials. Patient summary: Despite urodynamics being the gold standard to assess lower urinary tract symptoms (LUTS), as it is the only method that can specify lower urinary tract dysfunction, more studies assessing the clinical usefulness of urodynamic studies (UDSs) in the management of LUTS are needed. UDS investigation is not increasing the probability of success in the treatment of stress urinary incontinence.

Can operator-controlled imaging reduce fluoroscopy time during flexible ureterorenoscopy?

Introduction: Fluoroscopy is routinely used during ureterorenoscopy. According to the 'As Low As Reasonably Achievable' (ALARA) principle, radiation exposure should be kept as low as reasonably achievable to decrease the risk of negative long-term effects of radiation for patients and medical staff. This study aims to assess if operator-controlled imaging during flexible ureterorenoscopy for nephrolithiasis could reduce fluoroscopy time when compared to radiographer-controlled imaging. Material and methods: This study was a bicentric, retrospective comparison between patients treated for nephrolithiasis with flexible ureterorenoscopy with either operator-controlled imaging or radiographer-controlled imaging. A total of 100 patients were included, 50 were treated with operator-controlled imaging and 50 with radiographer-controlled imaging. Patients undergoing flexible ureterorenoscopy with a total stone burden <20 mm and data on radiation exposure were included. Patient characteristics, stone characteristics, surgical details and fluoroscopy time were recorded for each patient and both groups were compared. Patient data were expressed as median. A 2-sided p-value <0.005 was considered statistically significant. Results: This study found no significant differences between both groups regarding the patient and stone characteristics. However, it found a significant shorter fluoroscopy time in the operator-controlled imaging group of 33.5 seconds (IQR 16.0-70.0) compared to 57.0 seconds (IQR 36.8-95.3) in the radiographer-controlled imaging group (p = 0.001). Conclusions: This study shows that operator-controlled imaging in flexible ureterorenoscopy could reduce fluoroscopy time when compared to radiographer-controlled imaging. Operator-controlled imaging might therefore allow urologists to perform ureterorenoscopy with greater independence while additionally reducing fluoroscopy time and its consequent negative effects for medical staff and patients.

Early interventions to prevent lower urinary tract dysfunction after spinal cord injury: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: To synthetise the available scientific literature reporting early interventions to prevent neurogenic lower urinary tract dysfunction (NLUTD) after acute supra-sacral spinal cord injury (SCI). METHODS: The present systematic review is reported according to the PRISMA guidelines and identified articles published through April 2021 in the PubMed, Embase, ScienceDirect and Scopus databases with terms for early interventions to prevent NLUTD after SCI. Abstract and full-text screenings were performed by three reviewers independently, while two reviewers performed data extraction independently. An article was considered relevant if it assessed: an in-vivo model of supra-sacral SCI, including a group undergoing an early intervention compared with at least one control group, and reporting clinical, urodynamic, biological and/or histological data. RESULTS: Of the 30 studies included in the final synthesis, 9 focused on neurotransmission, 2 on the inflammatory response, 10 on neurotrophicity, 9 on electrical nerve modulation and 1 on multi-system neuroprosthetic training. Overall, 29/30 studies reported significant improvement in urodynamic parameters, for both the storage and the voiding phase. These findings were often associated with substantial modifications at the bladder and spinal cord level, including up/downregulation of neurotransmitters and receptors expression, neural proliferation or axonal sprouting and a reduction of inflammatory response and apoptosis. CONCLUSIONS: The present review supports the concept of early interventions to prevent NLUTD after supra-sacral SCI, allowing for the emergence of a potential preventive approach in the coming decades.

Acceptability and perceived value of urodynamics from the patient perspective: A narrative review.

BACKGROUND: The value and application of urodynamic evaluation (UDS) have been a controversial topic in recent years. Gaining robust data on the patient viewpoint in this area is important since, even when UDS findings do not change the management plan, the objective diagnostic information gained from UDS may be valued by patients. Moreover, insights from UDS may empower treating physicians to counsel patients more effectively and manage their expectations regarding treatment outcomes. OBJECTIVE: This expert narrative review aims to analyze the findings of published studies in this area, looking at two topics in turn: (a) the tolerability and acceptability of the UDS procedure itself from the patient perspective and (b) patient perceptions of the clinical value of insights provided by UDS. DESIGN, SETTING, PARTICIPANTS, AND OUTCOME MEASUREMENTS: An evidence assessment was conducted using selected articles from the literature reporting data on patients' perspectives on the tolerability, acceptability, utility, and value of the urodynamic investigation. RESULTS AND LIMITATIONS: Although pain, discomfort, and infection risks are frequently used as a rationale to skip UDS when initial management fails, there is good evidence that, from the patients' perspective, the procedure is very well tolerated in most cases. There are only a few articles available that assess patient perceptions of the usefulness of UDS, but those that do exist appear to demonstrate that the insights gained from UDS are widely welcomed by patients in the interest of receiving a more tailored and personalized treatment approach. CONCLUSION: From the patient perspective, UDS appears to be a well-accepted and well-tolerated diagnostic tool in patients with lower urinary tract symptoms, particularly when an appropriate explanation is provided before the examination. Our review also highlights that patients value the objective information provided by UDS and that this outweighs the temporary invasiveness of the test. This information is particularly relevant in light of the relative lack of evidence in the literature about patient expectations of specialist care in functional urology, which may have hindered progress with quality of care.

Does urinary urgency drive urinary frequency in overactive bladder?

OBJECTIVES: To determine if reduction in urgency in patients with refractory overactive bladder syndrome (rOAB) is correlated with a reduction in voiding frequency and symptom bother. METHODS: Data from a prospective series of women with rOAB undergoing radiofrequency ablation of the subtrigonal tissue, termed selective bladder denervation (SBD), was analyzed. Main outcome measures included urgency voids, nonurgency voids, and urgency urinary incontinence (UUI) epidsodes from a 3-day voiding diary and quality of life (QoL) measures (Overactive Bladder Questionnaire Short Form [OAB-q SF]). RESULTS: The dataset comprised 62 completer subjects at 6 months. Compared to baseline, UUI and urgency voids were lower (P < .001), but nonurgency voids were increased (P < .001) and QoL measures were improved (P < .001), but functional bladder capacity did not increase. At baseline and 6 months post treatment, symptom bother was correlated with urgency voids (P < .05) but inversely correlated with nonurgency voids (P < .001). Urgency and nonurgency voids were inversely related at baseline and at 6 months (P < .0001). Following treatment, urgency voids decreased by 41% and nonurgency voids increased by 33%. CONCLUSIONS: As with other interventions for OAB, SBD resulted in a reduction in OAB symptoms and an improvement in QoL measures. However, the decrease in urgency voids was offset by an increase in nonurgency voids, suggesting that habit or defensive voiding is a significant driver of urinary frequency. It is not certain if this is a unique finding of the SBD effect, but these data do suggest that analyses of outcomes of other OAB interventions are warranted to gain a better understanding of the genesis of OAB symptoms.

The Influence of Electrode Configuration Changes on the Sensory and Motor Response During (Re)Programming in Sacral Neuromodulation.

OBJECTIVES: This study aimed to assess the neurophysiological basis behind troubleshooting in sacral neuromodulation (SNM). Close follow-up of SNM patients with program parameter optimization has proven to be paramount by restoring clinical efficacy and avoiding surgical revision. MATERIALS AND METHODS: A total of 34 successful SNM patients (28 overactive bladder wet, six nonobstructive urinary retention) with an implantable pulse generator were included. All possible bipolar and monopolar electrode settings were tested at sensory threshold (ST) to evaluate sensory (mapped on a perineal grid with 1 cm2 coordinates) and motor (peak-to-peak amplitude and latency of muscle action potential) responses of the pelvic floor. Pelvic floor muscle electromyography was recorded using a multiple array probe, placed intravaginally. Parametric tests were used for paired data: repeated-measures ANOVA or t-test. A nonparametric test was used for paired data: Friedman ANOVA or Wilcoxon signed rank (WSR) test; p < 0.05 was considered statistically significant. If significant, ANOVA was followed by Dunn-Bonferroni post hoc analysis. RESULTS: Monopolar configurations showed significantly lower STs-1.38 ± 0.73 V vs 1.76 ± 0.89 V (paired t-test: p < 0.0001)-and presented with significantly higher peak-to-peak amplitudes-115.67 ± 79.03 µV vs 90.77 ± 80.55 µV (WSR: p = 0.005)-than bipolar configurations. When polarity was swapped, configurations with the cathode distal to the anode showed significantly lower STs, 1.73 ± 0.91 V vs 1.85 ± 0.87 V (paired t-test: p = 0.003), and mean peak-to-peak amplitudes, 81.32 ± 72.82 µV vs 100.21 ± 90.22 µV (WSR: p = 0.0001). Cathodal changes resulted in more changes in sensory responses than anodal changes (χ2 test: p = 0.044). In cathodal changes only, peak-to-peak amplitudes were significantly higher when the distance between electrodes was maximally spread (WSR: p = 0.046). CONCLUSIONS: From a neurophysiological point of view, monopolar configurations stimulated more motor nerve fibers at lower STs, therefore providing more therapeutic efficiency. Swapping polarity or changing the position of the cathode led to different sensory and motor responses, serving as potential reprogramming options.

Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects.

INTRODUCTION: Sacral Neuromodulation (SNM) is a minimally invasive treatment for OAB patients following failure of conventional interventions. Patient selection, lead placement, and testing technique are important pillars in optimizing success rates. AREAS COVERED: A comprehensive literature search was conducted on 'sacral neuromodulation' and 'overactive bladder.' There was no date restriction, with the last search dated 31 May 2021. Patient selection, lead placement, test phases, safety, efficacy, and available devices are thoroughly discussedLastly, future perspectives will be presented with the anticipated trajectory of sacral neuromodulation over the next five years. EXPERT OPINION/COMMENTARY: SNM has proved to be a safe and effective therapy on the short-, medium- and long-term without precluding any other treatment options. In all studies reviewed, no life threatening or major irreversible complications were presented. However, surgical re-intervention rates were high with a median of 33.2% (range: 8-34%) in studies with at least 24 months follow-up. No true consensus could be made regarding prognostic factors. However, optimized lead placement, consequent ideal motor thresholds, and the use of a curved stylet theoretically facilitates reaching maximal success with SNM. Test phase success rates increased to such a level that from a cost-effective point of view, single-stage implants could be considered.Abbreviations: OAB: overactive bladder; SNM: sacral neuromodulation; BoNT-A: Botulinum toxin A; PFM EMG: pelvic floor muscle electromyography; IPG: implantable pulse generator; PNE: percutaneous nerve evaluation; FSTLP: first-stage tined lead procedure; NLUTD: neurogenic lower urinary tract dysfunction; ITT: intention to threat; PPMC: per protocol modified completers; PPC: per protocol completers; AE: adverse event; MRI: magnetic resonance imaging; RCT: randomized controlled trial.

Sacral Neuromodulation Changes Pelvic Floor Activity in Overactive Bladder Patients-Possible New Insights in Mechanism of Action: A Pilot Study.

OBJECTIVES: To evaluate if electrodiagnostic tools can advance the understanding in the effect of sacral neuromodulation (SNM) on pelvic floor activity, more specifically if SNM induces changes in pelvic floor muscle (PFM) contraction. MATERIALS AND METHODS: Single tertiary center, prospective study (October 2017-May 2018) including patients with overactive bladder syndrome undergoing SNM. Electromyography of the PFM was recorded using the Multiple Array Probe Leiden. The procedure consisted of consecutive stimulations of the lead electrodes with increasing intensity (1-3, 5, 7, 10 V). Recordings were made after electrode placement (T0) and three weeks of SNM (T1). Patients with >50% improvement were defined as responders, others as nonresponders. For the analyses, the highest electrical PFM response (EPFMR), defined as the peak-to-peak amplitude of the muscle response, was identified for each intensity. The sensitivity (intensity where the first EPFMR was registered and the normalized EPFMR as percentage of maximum EPFMR) and the evolution (EMFPR changes over time) were analyzed using linear mixed models. RESULTS: Fourteen patients were analyzed (nine responders, five nonresponders). For nonresponders, the PFM was significantly less sensitive to stimulation after three weeks (T0: 1.7 V, T1: 2.6 V). The normalized EPFMR was (significantly) lower after three weeks for the ipsilateral side of the PFM for the clinically relevant voltages (1 V: 36%-23%; p = 0.024, 2 V: 56%-29%; p = 0.00001; 3 V: 63%-37%; p = 0.0002). For the nonresponders, the mean EPFMR was significantly lower at 8/12 locations at T1 (T0: 109 µV, T1: 58 µV; mean p = 0.013, range <0.0001-0.0867). For responders, the sensitivity and evolution did not change significantly. CONCLUSIONS: This is the first study to describe in detail the neurophysiological characteristics of the PFM, and the changes over time upon sacral spinal root stimulation, in responders and nonresponders to SNM. More research is needed to investigate the full potential of EPFMR as a response indicator.