British Association of Urological Surgeons Consensus statements on the management of ketamine uropathy.

OBJECTIVES: To provide guidance in the form of consensus statement in the management of ketamine uropathy. METHODS: A literature review of ketamine uropathy was performed. The consensus method was of a modified nominal group technique and has been use in the previous British Association of Urological Surgeons (BAUS) consensus documents and was led by the Female, Neurological and Urodynamic Urology Section of the BAUS. RESULTS: A number of consensus statements detailing the assessment and management of urological complications relate to the recreational use of ketamine (ketamine uropathy) in both elective and emergency urology settings. CONCLUSION: Comprehensive management pathway for ketamine-related urinary tract dysfunction and uropathy has been detailed.

Can we predict whether a man with acute or chronic urinary retention will void after bladder outflow resistance reduction surgery? ICI-RS 2023.

AIMS: To address the predictive factors of a successful voiding after bladder outflow resistance reduction surgery (BORRS) in men presenting with acute or chronic urinary retention (UR). METHODS: A think tank (TT) of ICI-RS was gathered in 2023, Bristol, UK, to discuss several aspects of the problem, such as the pathophysiology of UR, the clinical and urodynamic evaluation of men with UR and whether it is possible to predict which men will be able to successfully void after treatment with contemporary surgical options. RESULTS: The TT agreed that successful voiding after BORRS depends on several factors but that a strong recommendation cannot be made regarding preoperative evaluation and whether there are predictive factors of success because of the heterogeneity of patients and methodology in published trials. The diagnosis of obstruction in men with UR may be challenging when there is apparent reduced detrusor contraction during urodynamic studies. Even in the absence of bladder contractility there is documentation of such cases that have voided adequately after BORRS. Still, detrusor underactivity and inadequate relief of prostatic obstruction are the main causes of an unsuccessful voiding after BORRS. Conventional resection and enucleation methods remain the most successful surgeries in relieving UR in men, whereas the efficacy of minimally invasive surgical treatments needs to be assessed further. CONCLUSION: Research is needed to understand the pathophysiology of UR and the predictors of successful voiding after different types of BORRS in men with UR.

Can we predict and manage persistent storage and voiding LUTS following bladder outflow resistance reduction surgery in men? ICI-RS 2023.

AIMS: Lower urinary tract symptoms (LUTS) persist in up to 50% of patients after bladder outflow resistance reduction surgery (BORRS) in men. Our think tank aims to address the predictive factors for persistent LUTS after BORRS and to propose the recommendations for future research to enable improved better patient counseling and selection by more accurate prediction of treatment outcome. METHODS: A think tank of ICI-RS gathered in 2023, Bristol, UK, to discuss the pre and postsurgical clinical and urodynamic evaluation of men undergoing BORRS and whether it is possible to predict which men will have persistent LUTS after BORRS. RESULTS: Our think tank agrees that due to the multifactorial, and still not fully understood, etiology of male LUTS it is not possible to precisely predict in many men who will have persistent LUTS after BORRS. However, severe storage symptoms (overactive bladder, OAB) in association with low volume and high amplitude detrusor overactivity and low bladder capacity in preoperative urodynamics, increase the likelihood of persistent OAB/storage symptoms after BORRS. Furthermore, patients who are clearly obstructed and have good bladder contractility on preoperative pressure flow studies do better postoperatively compared to their counterparts. However, the benefit of pressure flow studies is decreased in patients who do not acceptably void during the study. Poor voiding after BORRS may occur due to persistent obstruction or detrusor underactivity. CONCLUSION: Future research is needed to increase our understanding of why male LUTS persist after surgery, and to enable better patient selection and more precise patient counseling before BORRS.

"An unprecedented occurrence: a case report of pulmonary hypertension manifestation in Donohue syndrome".

INTRODUCTION: Donohue syndrome (DS), also referred to as leprechaunism, is a remarkably uncommon autosomal recessive disorder that primarily affects the endocrine system. Its incidence rate is exceedingly low, with only 1 case reported per 4 million live births. The syndrome is distinguished by a series of characteristic clinical features. CASE PRESENTATION: We present a case of a twenty-month-old male with DS who experienced a range of dysmorphic and clinical features with the involvement of multiple systems. These features include skin hyperpigmentation, hypertrichosis, distinct facial features, abdominal distension, and microcephaly, with the involvement of the endocrine, renal, respiratory, and cardiac systems. CONCLUSION: The primary features of DS involve severe insulin resistance and growth abnormalities, the association with pulmonary hypertension (PHTN) has not been reported before. This finding adds more complexity to the condition. To the best of the author's knowledge, this is the first report for a patient with DS who has PHTN. Further investigation is required since the mechanisms behind the development of PHTN in DS are not entirely understood. Shedding light on this association will contribute to better management strategies and outcomes for affected patients.

The bladder contractility and bladder outlet obstruction indices in adult men: Results of a global Delphi consensus study.

AIMS: This Delphi study was planned to examine global expert consensus with regard to utility, accuracy, and categorization of Bladder Contractility Index (BCI) and Bladder Outlet Obstruction Index (BOOI) and the related evidence. METHODS: Twenty-eight experts were invited to answer the two-round survey including three foundation questions and 15 survey questions. Consensus was defined as ≥75% agreement. The ordinal scale (0-10) in round 1 was classified into "strongly agree," "agree," "neutral," "disagree," and "strongly disagree" for the final round. A systematic search for evidence was conducted for therapeutic studies that have examined outcome stratified by the indices in men. RESULTS: Nineteen experts participated in the survey with 100% completion. Consensus was noted with regard to 6 of 19 questions. Experts strongly agreed with utility of quantifying bladder contractility and bladder outflow obstruction with near unanimity regarding the latter. There was consensus that BCI and BOOI were accurate, that BCI was clinically useful, and for defining severe bladder outflow obstruction as BOOI > 80. Systematic search yielded 69 publications (BCI 45; BOOI 50). Most studies examined the indices as a continuous variable or by standard cutoffs (BCI 100, 150; BOOI 20, 40). CONCLUSION: There is general agreement among experts on need for indices to quantify bladder contractility and bladder outflow obstruction as well as with regard to accuracy and utility of BCI and BOOI indices. Few studies have examined the discriminant power of existing cutoffs or explored new ones. This is an extraordinary knowledge gap in the field of urology.

The bladder contractility and bladder outlet obstruction indices in children. Results of a global Delphi consensus study.

AIMS: This Delphi study was planned to examine global expert consensus with regard to utility, accuracy, and categorization of Bladder Contractility Index (BCI), Bladder Outlet Obstruction Index (BOOI), and the related evidence. This manuscript deals with children and follows previous manuscripts reporting on adult men and women. METHODS: Eighteen experts were invited to answer the two-round survey including three foundation questions and four survey questions. Consensus was defined as ≥75% agreement. The ordinal scale (0-10) in Round 1 was classified into "strongly agree," "agree," "neutral," "disagree," and "strongly disagree" for the final round. A systematic search for evidence was conducted for therapeutic studies that have examined outcome stratified by the indices in children. RESULTS: Eleven experts participated in the survey with 100% completion. Consensus was not noted with regard to any of the questions. There was a general trend toward disagreement with the utility of the BCI and BOOI in children. Systematic search yielded one publication pertaining the value of the indices in predicting long-term outcome in boys treated for posterior urethral valves. CONCLUSIONS: This global Delphi survey of experts showed a general disinclination to use numerical indices for bladder contractility and bladder outflow obstruction in children. There is very little data on the use of the BCI and BOOI indices in children. The establishment of urodynamic indices in children might help refine the treatment of functional urological disorders in children.

The bladder contractility and bladder outlet obstruction indices in adult women. Results of a global Delphi consensus study.

AIMS: This Delphi study was planned to examine global expert consensus with regard to utility, accuracy, and categorization of the bladder contractility index (BCI), bladder outlet obstruction index (BOOI), and the related evidence. This manuscript deals with adult women and follows a previous manuscript reporting on adult men. METHODS: Twenty-nine experts were invited to answer the two-round survey including three foundation questions and 12 survey questions. Consensus was defined as ≥75% agreement. The ordinal scale (0-10) in round 1 was classified into "strongly agree," "agree," "neutral," "disagree," and "strongly disagree" for the final round. A systematic search for evidence was conducted for therapeutic studies that have examined outcome stratified by the indices in women. RESULTS: Eighteen experts participated in the survey with 100% completion. Consensus was noted with regard to 2 of 12 questions, both in the negative. The experts had a consensus that BOOI was neither accurate nor useful and a similar negative trend was noted with regard to BCI. However, there was support, short of consensus, for the utility on an index of bladder contractility and bladder outflow obstruction. Systematic search yielded eight publications pertaining to stress urinary incontinence (n = 6), pelvic organ prolapse (n = 1), and intra-sphincteric botulinum toxin (n = 1). CONCLUSIONS: Experts had significant concerns with regard to the use of the male BCI and BOOI in adult women despite a general recognition of the need for numerical indices of contractility and obstruction. Systematic search showed a striking lack of evidence in this regard.

Evaluation of new treatments for benign prostatic obstruction: ICI-RS 2023.

AIMS: To address how invasive therapies for benign prostatic obstruction (BPO) have been evaluated, what their effect is on BPO, if they can prevent progression to BPO and how new therapies need to be evaluated before implementation into clinical practice. METHODS: The think tank conducted a literature review and looked at the previous and current American Urological Association, European Association of Urology and the International Consultation on Urological Diseases guidelines to see what procedures have been used to treat BPO. They then assessed whether trials have been conducted before implementation of the procedures and whether they have been compared to a "gold" standard treatment. The use of urodynamics has also been addressed in the think tank in relation the clinical trials as well as terminology. RESULTS: Guidelines vary in the use of terminology when it comes to BPO with some continuing to use the term benign prostatic hyperplasia (BPH). There are several procedures for example, TUNA, which have become obsolete although continues to be mentioned in the guidelines until recently. Majority of procedures have been introduced without comparing to "gold" standard treatment and without any long-term data. There continues to be many unknowns with regard to the success of some of the BPO procedures and why some of the adverse events develop. CONCLUSION: There needs to be more robust long-term clinical trials conducted of new BPO therapies, with men who have both lower urinary tract symptoms and urinary retention, before introduction into clinical practice.

How should we assess the cardiovascular system in patients presenting with bothersome nocturia? ICI-RS 2023.

AIMS: The link between nocturia and cardiovascular disease (CVD) is frequently discussed in literature, yet the precise nature of this relationship remains poorly characterized. The existing literature was reviewed in order to address issues concerning the origin, diagnosis, management, and implications of the co-occurrence of CVD and nocturia. METHODS: This review summarizes literature and recommendations regarding the link between CVD and nocturia discussed during a think-tank meeting held at the 2023 International Consultation on Incontinence-Research Society. RESULTS: Cardiovascular disorders are often underestimated contributors to nocturia, with various potential mechanisms influencing nighttime urination, such as impact on fluid retention, atrial natriuretic peptide, and glomerular filtration rate. The redistribution of fluid from leg edema in supine position can lead nocturnal polyuria (NP). Additionally, sleep disturbances due to nocturia in itself may lead to CVD through an increase in blood pressure, insulin resistance, and inflammation. Disrupted circadian rhythms (e.g., in sleep pattern and urine production) were identified as critical factors in most etiologies of nocturia, and their contribution is deemed imperative in future research and treatment approaches, particularly in the aging population. NP can be detected through a simple bladder diary and can even be used to distinguish cardiac from noncardiac causes of nocturia. For the treatment of NP, desmopressin can be effective in select patients, however, caution and close monitoring is warranted for those with CVD due to increased risk of side effects. CONCLUSIONS: Gaps were identified in the available evidence and clear cut recommendations were put forth for future research. It is essential to gain a deeper understanding of the mechanisms linking nocturia and CVD to develop optimal management strategies.

New therapeutic targets to prevent benign prostatic enlargement and symptomatic progression to benign prostatic obstruction-ICI-RS 2023.

AIMS: Benign prostatic enlargement (BPE) can impact lower urinary tract function due to its potential progression to benign prostatic obstruction (BPO). Treatment options include removal of the obstruction by surgery or through use of therapeutics designed to slow growth or reduce tissue stress imposed by muscular stromal components. Inflammation and development of fibrosis can also raise intrinsic tissue stress within the gland, further impacting obstruction. Outflow tract obstruction can also impact emission and ejaculation if the obstruction persists. METHODS: This review summarizes an ICI-RS think tank considering novel drug treatments that might address BPO caused by progressive development of BPE, as well as manage decompensation changes to bladder function. RESULTS: Topics included recent advances in our understanding of pathological changes occurring to the prostate and other lower urinary tract tissues during progressive development of BPE, and how prevention or reversal might benefit from the identification of novel drug targets. These included contractile properties of prostatic tissues, the impact of BPE and its effects on bladder function, the deposition of intramural fibrotic tissue with protracted BPO, the role of inflammation in the development of BPE and its progression to BPO. In particular, we discussed current therapeutic options for treating BPE/BPO, and new therapeutic targets, what they treat and their advantage over current medications. CONCLUSION: Several new drug targets were identified, including soluble guanylate cyclase (sGC), the receptor for nitric oxide (NO•), and sGC activators that promotes sGC-mediated cGMP production when sGC is inactivated and unresponsive to NO•.

Can we improve techniques and patients' selection for nerve stimulation suitable for lower urinary tract dysfunctions? ICI-RS 2023.

AIMS: Lower urinary tract dysfunctions (LUTD) are very common and, importantly, affect patients' quality of life (QoL). LUTD can range from urinary retention to urgency incontinence and includes a variety of symptoms. Nerve stimulation (NS) is an accepted widespread treatment with documented success for LUTD and is used widely. The aim of this review is to report the results of the discussion about how to improve the outcomes of NS for LUTD treatment. METHODS: During its 2023 meeting in Bristol, the International Consultation on Incontinence Research Society discussed a literature review, and there was an expert consensus discussion focused on the emerging awareness of NS suitable for LUTD. RESULTS: The consensus discussed how to improve techniques and patients' selection in NS, and high-priority research questions were identified. CONCLUSIONS: Technique improvement, device programming, and patient selection are the goals of the current approach to NS. The conditional nerve stimulation with minimally invasive wireless systems and tailored algorithms hold promise for improving NS for LUTD, particularly for patients with neurogenic bladder who represent the new extended population to be treated.

Which parameters, related to the female urethra and pelvic floor, determine therapy selection for recurrent female stress urinary incontinence: ICI-RS 2023?

INTRODUCTION: The evidence basis for therapy selection in women who have failed primary stress urinary incontinence (SUI) surgery is limited. The ICI-RS group discussed the available data at its meeting in June 2023, particularly the anatomical characteristics as assessed using magnetic resonance imaging (MRI) and ultrasound (US) modalities, functional characteristics associated with storage and voiding urodynamic assessment, as well as the patient characteristics that might influence outcomes. This paper summarizes the evidence base that supported these discussions and offers the basis for research proposals for future groups. METHODS: A literature search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was performed, and the data is presented. Research questions are based on the knowledge gaps highlighted. RESULTS: Possible MRI parameters that may influence outcomes were striated urethral sphincter volume, bladder and proximal urethral funneling, pubo-urethral ligament integrity, distance of the bladder neck below the pubococcygeal line, posterior urethra-vesical angle, and bladder neck to levator ani distance. US parameters included sling distance to the urethral lumen and pubis, sling position, bladder neck mobility, and lateral arm asymmetry, twisting, or curling. Urodynamic parameters included detrusor overactivity, Valsalva leak point pressure, maximum urethral closure pressure, and bladder outlet obstruction. Important patient parameters included body mass index, age, and previous interventions. CONCLUSIONS: Identifying and quantifying causative factors in patients with recurrent SUI, that allow clinicians to modify subsequent treatment choices and techniques may help reduce treatment failure and complications. Formulating algorithms is the next step in optimizing patient counseling, surgical selection, and healthcare allocation.

Sleep Disorders, Comorbidities, Actions, Lower Urinary Tract Dysfunction, and Medications ("Sleep C.A.L.M.") in the evaluation and management of nocturia: A simple approach to a complex diagnosis.

INTRODUCTION: Nocturia arises from a fundamental mismatch between nocturnal urine production, storage capacity, and sleep architecture, which may be driven by abnormalities of the genitourinary tract, but also by sleep disorders, medical diseases, patient actions/lifestyle factors, or medications. This article introduces a novel system for organizing the complex differential diagnosis for nocturia, as proposed by an international collective of practicing urologists, physician specialists, and sleep experts: "Sleep CALM"-Sleep Disorders, Comorbidities, Actions, Lower Urinary Tract Dysfunction, and Medications. METHODS: Narrative review of current evidence regarding the relevance of each "Sleep CALM" factor to nocturia pathogenesis, evaluation, and management. RESULTS: Nocturia and sleep disorders are highly intertwined and often bidirectional, such that nocturnal awakenings for reasons other than a sensation of bladder fullness should not be used as grounds for exclusion from nocturia treatment, but rather leveraged to broaden therapeutic options for nocturia. Nocturia is an important potential harbinger of several serious medical conditions beyond the genitourinary tract. Urologists should have a low threshold for primary care and medical specialty referral for medical optimization, which carries the potential to significantly improve nocturnal voiding frequency in addition to overall health status. Adverse patient actions/lifestyle factors, lower urinary tract dysfunction, and medication use commonly coexist with disordered sleep and comorbid medical conditions, and may be the primary mediators of nocturia severity and treatment response, or further exacerbate nocturia severity and complicate treatment. CONCLUSION: "Sleep CALM" provides a memorable and clinically relevant means by which to structure the initial patient history, physical exam, and clinical testing in accordance with current best-practice guidelines for nocturia. Although not intended as an all-encompassing diagnostic tool, the "Sleep CALM" schema may also be useful in guiding individualized ancillary testing, identifying the need for specialty referral and multidisciplinary care, and uncovering first-line treatment targets.

Psychometric properties of the Alcohol Use Disorders Identification Test (AUDIT) across cross-cultural subgroups, genders, and sexual orientations: Findings from the International Sex Survey (ISS).

INTRODUCTION: Despite being a widely used screening questionnaire, there is no consensus on the most appropriate measurement model for the Alcohol Use Disorders Identification Test (AUDIT). Furthermore, there have been limited studies on its measurement invariance across cross-cultural subgroups, genders, and sexual orientations. AIMS: The present study aimed to examine the fit of different measurement models for the AUDIT and its measurement invariance across a wide range of subgroups by country, language, gender, and sexual orientation. METHODS: Responses concerning past-year alcohol use from the participants of the cross-sectional International Sex Survey were considered (N = 62,943; Mage: 32.73; SD = 12.59). Confirmatory factor analysis, as well as measurement invariance tests were performed for 21 countries, 14 languages, three genders, and four sexual-orientation subgroups that met the minimum sample size requirement for inclusion in these analyses. RESULTS: A two-factor model with factors describing 'alcohol use' (items 1-3) and 'alcohol problems' (items 4-10) showed the best model fit across countries, languages, genders, and sexual orientations. For the former two, scalar and latent mean levels of invariance were reached considering different criteria. For gender and sexual orientation, a latent mean level of invariance was reached. CONCLUSIONS: In line with the two-factor model, the calculation of separate alcohol-use and alcohol-problem scores is recommended when using the AUDIT. The high levels of measurement invariance achieved for the AUDIT support its use in cross-cultural research, capable also of meaningful comparisons among genders and sexual orientations.

How I Do It: Transcutaneous tibial nerve stimulation TENSI+ system.

Overactive bladder (OAB) is a common condition that significantly impacts the quality of life (QoL), well-being and daily functioning for both men and women. Among various treatments, peripheral tibial nerve stimulation (PTNS) emerges as an effective third-line treatment for OAB symptoms, with options for either a percutaneous approach (P-PTNS) or by transcutaneous delivery (T-PTNS). Recent studies have shown negligible differences between P-PTNS and T-PTNS efficacy in alleviating urinary urgency and frequency and QoL improvement and, overall no difference in efficacy over antimuscarinic regimens. The TENSI+ system offers a cutting-edge transcutaneous approach, allowing patients to self-administer treatment conveniently at home with electrical stimulation delivery through surface electrodes. It stands out for its ease of preparation, tolerability, and high levels of patient satisfaction. Prospective multicentric data highlights TENSI+ to be an effective and safe treatment for lower urinary tract symptoms with high treatment adherence at 3 months. This paper aims to familiarize readers with the TENSI+ system, current studies, device assembly, operation, and treatment recommendations.

Bristol UTraQ: A proposed system for scoring the technical quality of urodynamic traces.

AIM: To develop and test a scoring system for the technical quality of a urodynamic trace METHODS: Rasch analysis was used to select the most discriminating questions relating to good urodynamic practices. The questions were taken from International Continence Society standard documents and tested on 60 traces of varying quality and from different sources. RESULTS: Twenty-five questions were selected by this process. These were tested with 10 traces by seven scorers, and with 60 traces by a single scorer. A pass quality score of 75% resulted in good discrimination between good and poor traces. Further editing and clarification resulted in a final score sheet of 23 Yes/No questions. CONCLUSION: A proposed scoring system, "Bristol UTraQ," for the technical quality of urodynamic traces has been developed and tested. We suggest a score above 75% indicates acceptable trace technical quality. High technical quality is the essential first step in ensuring that urodynamic studies can answer the urodynamic questions for every patient. Plans for further validation are outlined.

Efficacy of combination therapy of mid-urethral sling and low-dose Abobotulinumtoxin-A injection in mixed urinary incontinence.

OBJECTIVES: To determine the outcome of combined transobturator tape sling (TOT) and low dose intradetrusor injection of Abobotulinumtoxin-A (Abobot-A, Dysport®) in women with mixed urinary incontinence (MUI). METHODS: This randomized, active comparator-controlled, parallel-group, two-part clinical trial was conducted on women who had positive Valsalva leak point pressure (VLPP) + detrusor overactivity (DO), cough-associated DO. In Part 1, 20 women with MUI who had a failure of medical and behavioral therapies to cure MUI, randomized in two groups receiving TOT surgery alone, or in combination with Dysport® injection (n = 10 in each group), and then Part 2 was initiated as a prospective open-label on 40 more patients. We performed cystoscopy and injected 300 U of Dysport®in 20-30 intradetrusor injection sites in each patient. RESULTS: The patient's symptoms in both groups decreased significantly after treatment. The symptoms were improved significantly in the combination therapy group according to the International Consultation on Incontinence Questionnaire-overactive bladder (ICIQ-OAB) questionnaire (p < .001), and International Consultation on Incontinence Questionnaire-urinary Incontinence-short form (ICIQ-UI-SF) (p = .041) in comparing with the TOT group. In Part 2, the mean score was 17.10 (4.75) for ICIQ-UI-SF and 9.22 (2.89) for ICIQ-OAB before the treatment. Twelve weeks after the intervention, the median (interquartile range: IQR) of ICIQ-OAB symptoms (2.0 [3.0]; p < .001) and ICIQ-UI-SF decreased, too (1. 0 [2.0]; p < .001). Considering improvement using Patient Global Impression of Improvement scale, 46 (92.0%) stated that they had significant subjective improvement of their symptoms. CONCLUSIONS: Combination therapy was accompanied with a promising effect in the patients with MUI according to the results of standardized questionnaires. However, further studies with controlled arms are recommended.

Development of a questionnaire set to evaluate adaptations to COVID era: The ICS TURNOVER project (Transition of fUnctional uRology to New COVID ERa).

OBJECTIVES: Coronavirus disease 2019 (COVID-19) pandemic has caused a massive cutdown in outpatient urological investigations, procedures, and interventions. Female and functional urology (FFU) has been probably the most affected subspecialty in urology. Several scientific societies have published guidelines to manage this new situation, providing general recommendations. The aim of this study was to devise a robust questionnaire covering every different aspect of FFU to obtain recommendations on COVID-19 adaptations. METHODS: Delphi methodology was adapted to devise the survey questionnaires for male/female lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP), chronic pelvic pain (CPP), and neuro-urological disease. Content validity, face validity, and internal consistence were assessed to establish the final questionnaire. This study was ethically approved by the Local Research Ethics Committee. RESULTS: A total 97, 59, 79, 85, and 84 items for female and male LUTS, POPs, CPP, and neuro-urology respectively were approved by the participants. Content validity over 0.70 was obtained which seemed reasonable content validity scores. Internal consistency obtains values of Cronbach's alpha was between 0.70 and 0.90 which was acceptable. CONCLUSIONS: The collective wisdom obtained through a global survey using validated questionnaires covering every different aspect of FFU patient management is necessary. We have developed a robust and validated tool consisting of five questionnaires covering the most prevalent pathologies in FFU.

Sacral neuromodulation in patients with detrusor underactivity: Is biological sex an indicator?

OBJECTIVES: This study aimed to report sacral neuromodulation (SNM) outcomes in detrusor underactivity (DU). METHODS: A multicentric, multinational, retrospective case series was conducted between March 2017 and June 2021 in three different referral centers. Initial test phase stimulation included either a percutaneous nerve evaluation (PNE) or an advanced lead evaluation test phase (ALTP) before permanent SNM implantation. The test phases were performed under local anesthesia, either in the outpatient (PNE) or operating room (ALTP), in the prone position, which was implanted in the third or fourth sacral foramina under fluoroscopic guidance. Patients with favorable response to the initial test phase during the first 2 weeks underwent the implantable pulse generator (IPG) implantation (Medtronic neurostimulation generator device InterStim™). Favorable response was defined as ≥ 50% improvement in symptoms, frequency of clean intermittent catheterization (CIC) and/or decrease in postvoid residual (PVR), increase in voided volume, or improvement in bladder voiding efficiency (BVE) based on the bladder diary. RESULTS: Fifty-eight patients were recruited with a mean age of 39.95 ± 15.28 years. Among the 58 cases, 36 (62.1%) patients responded to the initial stage. Of these, 12 patients (30.8%) with non-neurogenic etiology and nine patients (52.9%) with neurologic etiology did not respond to the initial test phase; thus, they did not undergo full implantation (p = 0.141). Voided volume, PVR, and the median maximum flow rate (Qmax) improved significantly (p < 0.001) in both sexes; however, there was no statistical difference between both genders. Most female cases (78.3%), and nearly half of the men (51.4%), responded to the test phase and were candidates for the IPG phase. Among the 35 cases who underwent IPG, 27 patients (72.2% of males, and 77.8% of females; p = 0.700) had a favorable response to IPG. 46.6% of patients had a successful outcome at the end of the study. CONCLUSION: This multicentric study showed that SNM effectively and safely provided symptom improvement in refractory DU in males similar to females which is an important finding as previously it has been suggested that SNM works better in nonobstructive urinary retention in women and not in women.

Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation.

AIMS: The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. METHODS: Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit). RESULTS: One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 ± 3.4 urinary incontinence episodes/day at baseline and 2.2 ± 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 ± 4.4 voids/day at baseline and 10.5 ± 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. CONCLUSIONS: The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.