QuestionAre reusable catheters noninferior to single-use catheters for intermittent catheterization in cases of urinary tract infections?FindingsIn this randomized clinical trial of 386 participants, the incidence rate of urinary tract infections per patient-month was similar between the single-use and reusable catheter groups, and the predefined noninferiority margin was met.MeaningThis study's findings suggest that reusable catheters are as safe as single-use catheters, thereby supporting sustainable and equitable urologic care. This randomized clinical trial compares urinary tract infection incidence in patients aged 16 years or older using single-use vs reusable catheters in Dutch hospitals. ImportanceClean intermittent catheterization (CIC) is the preferred management for urinary retention. Single-use catheters generate substantial environmental and financial burdens, whereas evidence on the safety of reusable catheters is limited.ObjectiveTo examine whether reusable catheters are noninferior to single-use catheters for CIC with respect to urinary tract infection (UTI) incidence.Design, Setting, and ParticipantsThis multicenter, noninferiority randomized clinical trial was conducted between February 21, 2020, and April 3, 2025, at 12 Dutch hospitals and included patients aged 16 years or older performing CIC at least twice daily, with 1-year follow-up.InterventionsParticipants were randomly assigned to reusable or single-use catheters. Reusable catheters were disinfected daily in 2% sodium hypochlorite solution, rinsed before and after use, and replaced every 2 weeks; single-use catheters were permitted for 20% or less of weekly catheterizations in the reusable group.Main Outcomes and MeasuresThe primary outcome was UTI incidence per patient-month. Secondary outcomes included catheter-related complications, adverse events, and patient-reported outcomes. The noninferiority margin was set at an absolute difference of 0.07 UTIs per patient-month.ResultsA total of 386 patients (mean [SD] age, 61.4 [15.9] years; 243 [63%] male; and 139 [36%] with neurogenic lower urinary tract dysfunction) were included. In the reusable catheter group, 72 of 185 participants (39.0%) discontinued study participation, mainly due to reduced ease of use and urethral irritation. In the modified intention-to-treat population (n = 326), mean (SD) follow-up was 12.0 (1.9) months in the single-use group and 11.4 (2.9) months in the reusable group. During this period, 1 or more UTIs occurred in 59 of 191 single-use catheter users (30.9%) and 40 of 134 reusable catheter users (29.9%). The incidence rate was 0.054 (95% CI, 0.040-0.069) vs 0.050 (95% CI, 0.035-0.067) UTIs per patient-month, with an absolute difference of -0.004 (95% CI, -0.025 to 0.019), meeting the predefined noninferiority margin. Catheter-related complications and serious adverse events were comparable between groups, whereas low-grade adverse events, mainly urethral irritation, were more frequent in the reusable group (37 [20.0%] vs 9 [4.7%]). Catheter-related quality of life was higher with reusable catheters, whereas catheterization satisfaction was higher with single-use catheters; overall health-related quality of life did not differ between groups.Conclusions and RelevanceIn this randomized clinical trial of patients with urinary retention, reusable catheters were noninferior to single-use catheters for UTIs, with variable tolerability and patient-reported outcomes highlighting the importance of individual preference and the need for design enhancements to improve usability and broaden implementation.Trial RegistrationNational Trial Register: NL8296
The Measure Yourself Medical Outcome Profile 2 (MYMOP2) is a patient-generated outcome measure allowing patients to describe their most important problems in their own words, scoring the severity of symptoms and scoring the effect these have on their quality of life (QoL). The objective of this study was to translate and validate a Dutch version of the MYMOP2 questionnaire for patients with non-neurogenic functional bladder disorders. The translation into the Dutch MYMOP2 questionnaire was performed according to standardized guidelines. Patients with non-neurogenic functional bladder disorders who visited a tertiary urology department were asked to fill in the Dutch MYMOP2, the Urogenital Distress Inventory 6 (UDI-6), and the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) at baseline (test) and 2 weeks later (retest). No reference group was included, as the MYMOP2 questionnaire is not symptom specific. The evaluated measurement properties were construct validity, reproducibility, content validity, criterion validity, and floor or ceiling effects of the Dutch version of the MYMOP2. Fifty-eight patients were included. Content validity was adequate, and the reproducibility was also adequate (intraclass correlation 0.88). Criterion and construct validity were also confirmed; MYMOP2 scores correlated significantly with the UDI-6 and EQ-5D-5L. The Dutch version of the MYMOP2 is a reliable outcome measure for non-neurogenic bladder patients as it indicates moderate-to-good measurement properties. We recommend using this questionnaire in clinical evaluation as it enables patients with multiple complaints to describe these in their own words.
Schone intermitterende katheterisatie (CIC) wordt vaak verkozen boven verblijfskatheters (CAD) vanwege een lager risico op complicaties en verbeterde levenskwaliteit. Dit onderzoek richt zich op trends en regionale verschillen in het gebruik van CIC en CAD onder thuiswonenden in Nederland tussen 2012 en 2021. Er werden gegevens verzameld uit het Genees- en hulpmiddeleninformatieproject (GIP) en er werden regionale verschillen geëvalueerd met negatieve binomiale regressie (NBR). Het aantal CIC-gebruikers steeg met 27,3
Een benigne urethrale poliep is een zeldzame aandoening op kinderleeftijd die kan leiden tot mictieklachten en/of hematurie. De differentiële diagnose is uitgebreid en bevat onder andere rhabdomyosarcoom. We presenteren vier casussen uit Nederland met een benigne poliep. De klachten en leeftijden variëren. De oorzaak is niet duidelijk. Mogelijk is er sprake van een restant van de buizen van Müller, maar omdat een urethrale poliep ook bij meisjes kan voorkomen, is deze verklaring omstreden. De afwijking bevindt zich meestal ter hoogte van de colliculus en wordt histologisch beschreven als fibro-epitheliale poliep. Als een maligniteit onwaarschijnlijk is, heeft een transurethrale resectie de voorkeur. Cystoscopie wordt gebruikt als diagnosticum en behandeling. Een recidief wordt niet beschreven.
Alternatieve behandelopties voor urineweginfecties (UWI’s) zijn nodig door toenemende antibioticaresistentie. Dit onderzoek richtte zich op de veiligheid, effectiviteit en behandelingstevredenheid van blaasspoelen met kraanwater (BSK) bij kathetergebruikers met recidiverende UWI’s. In dit prospectieve, observationele onderzoek werden gedurende een periode van 3 maanden het aantal antibioticakuren, het aantal UWI’s en de behandelingstevredenheid van dezelfde patiënten met en zonder BSK vergeleken. Bij 60 patiënten daalde het antibioticagebruik met 38,1
Background: Clean intermittent catheterization (CIC) is the golden standard in patients with lower urinary tract dysfunction, leading to bladder emptying problems, due to neurogenic or non-neurogenic causes. CIC affects patient Quality of Life (QoL) both positively and negatively. Objectives: The aim of this systematic review is to determine which measurements are used to report on the QoL of patients who are on CIC in the currently available literature, to determine the overall QoL of patients who are on CIC and lastly, to determine whether QoL in patients who are on CIC is dependent on the underlying cause (neurogenic vs non-neurogenic). Design: This systematic review was conducted following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data sources and methods: The Embase, Medline, Web of Science Core Collection, CINAHL, Google Scholar, and the Cochrane CENTRAL register of trials databases were systematically searched for relevant publications until March 2023. Results: A total of 4430 abstracts were screened and 43 studies were included. Studies were published between 1993 and 2022 and consisted of only neurogenic patients in 22 studies, the others included a mixed population. The included patient populations and the used measurements/tools were heterogeneous. There were 21 measurements/tools used to measure QoL, of which 3 were not validated. One questionnaire was developed to measure QoL in patients on CIC (intermittent self-catheterization questionnaire). Other measurements were suitable for general health-related QoL, to evaluate neurogenic bladder symptoms or incontinence oriented. Conclusion: The 43 included studies showed a great variety of used tools to measure QoL in patients on CIC due to neurogenic and non-neurogenic causes. Because of lacking uniformity of the measured aspects of QoL, the different included studies could not be compared and subgroup analysis was not performed. Recommendations for future research and practice are provided. Trial registration: This systematic review was registered and published beforehand at Prospero (CRD42020181777; https://www.crd.york.ac.uk/prospero ).
OBJECTIVE:To evaluate the safety and effectiveness of bladder irrigation (BI) with tap water to reduce antibiotic use for the treatment of urinary tract infections (UTIs) in patients with recurrent UTI symptoms and to assess the treatment satisfaction of BI. PATIENTS AND METHODS:This prospective, observational study included patients with an indwelling catheter or performing clean intermittent catheterisation (CIC) who had recurrent UTI symptoms between July 2022 and March 2024. BI with tap water was used for the treatment of UTIs without systemic symptoms (e.g., fever, flank pain or delirium). Patients started daily irrigation at the onset of UTI symptoms and used a tapering schedule. The number of antibiotic treatments for UTIs, UTI incidence rate ratio (IRR), UTI-related hospitalisations, treatment satisfaction and quality of life (QoL) were compared between a 3-month period before and after BI with tap water. RESULTS:A total of 60 patients were included with a median (interquartile range) age of 64.5 (50.4-72.6) years, 66.7% were male, and 83.3% were performing CIC. Antibiotic use was decreased on average by 38.1% (IRR = 0.62; P = 0.016) and catheter-associated UTIs by 37.9% (IRR = 0.62; P = 0.005). No increase was observed in the incidence of UTIs with systemic symptoms or UTI-related hospitalisations. In addition, no differences were observed in the health-related QoL. The majority of patients were positive about the subjective effectiveness (81%), ease of use (86%) and overall satisfaction (85%) of BI with tap water. CONCLUSION:These findings emphasise the potential of BI with tap water as a promising and patient-friendly alternative for the treatment of UTIs in patients with urinary catheters. BI with tap water significantly reduces antibiotic use and UTI incidence in patients with recurrent UTIs and is a safe and patient-friendly alternative that can be easily implemented in the management of UTIs.
Dysfunctional voiding (DV) is a habitual voiding disorder caused by involuntary contraction or nonrelaxation of the external urethral sphincter (EUS) during voiding. This contraction causes high postvoid residuals (PVR), urinary incontinence and urinary tract infections (UTIs). Various treatments for DV are available, but some children do not respond. Intersphincteric botulinum toxin-A (BTX-A) may be a possible treatment for therapy-refractory children with DV.
BACKGROUND:The first studies on patients with forkhead-box protein P1 (FOXP1) syndrome reported associated global neurodevelopmental delay, autism symptomatology, dysmorphic features and cardiac and urogenital malformations. The aim of this study was to assess the prevalence of congenital abnormalities in an unbiased cohort of patients with FOXP1 syndrome and to document rare complications. METHODS:Patients with FOXP1 syndrome were included, mostly diagnosed via whole-exome sequencing for neurodevelopmental delay. A parent-report questionnaire was used to assess medical signs and symptoms, including questions about features rated as most burdensome by patients and their family. RESULTS:Forty individuals were included, 20 females and 20 males. The mean age at assessment was 13.2 years (median 8.5 years; range 2-54 years; ≥18 years n = 7). Seven adults were included. All patients had developmental problems, including cognitive, communication, social-emotional and motor delays. The most prevalent medical signs and symptoms include delayed bladder control, sleeping problems, hypermetropia, strabismus, sacral dimple, undescended testes, abnormal muscle tone and airway infections. The most burdensome complaints for patients with FOXP1 syndrome, as perceived by parents, include intellectual disability, impaired communication, behaviour problems, lack of age-appropriate self-reliance, attention problems and anxiety. According to parents, patients have quite similar reported symptoms, although incontinence, obsessions and a complex sensory profile have a higher ranking. CONCLUSION:The results of this study may be used to further guide medical management and identify patient priorities for future research targeted on those features of FOXP1 syndrome that most impair quality of life of patients and their families.
IntroductionNeurogenic lower urinary tract dysfunction (NLUTD) in children can cause renal failure and urinary in-continence if not treated sufficiently. Anti-muscarinics (AM) and intradetrusor botulinum toxin injections (BoNT-A) with clean intermittent cathe-terization (CIC) are widely used treatment options for children with NLUTD. However, a considerable number will become refractory to these treatment options. This study aimed to evaluate the efficacy and long-term outcomes of mirabegron in children with NLUTD as an add-on and as a stand-alone treatment.Material and methodsPatients under 18 years of age with NLUTD who were refractory to AM and/or BoNT-A and were treated with mirabegron 50 mg were retrospectively studied. Mirabegron was either used as monotherapy or in addition to AM and/or BoNT-A. Video-urodynamic studies (VUDSs) were performed before and after treatment with mirabegron. Changes in video-urodynamic parameters, the need for other NLUTD therapy during follow-up, patient-reported side ef-fects, and urinary incontinence were outcomes of interest.ResultsA total of 34 patients with NLUTD were included. All patients were on CIC and the median age was 13.1 years (IQR 15.9-10.3). Median follow-up was 31.4 months (IQR 57.4-11.4). Bladder compliance improved by 89.9%, from 14.9 to 28.3 ml/cm H2O (p-value<0.001). Maximum cystometric capacity, end-filling detrusor pressure, volume at first detrusor overactivity, vesicoureteral reflux, and urinary in-continence significantly improved after mirabegron. The add-on therapy group showed more significant improvements in video-urodynamic outcomes compared to the monotherapy group. The median time of requiring other NLUTD therapy was 25.5 months (IQR 39.8-14.8). None of the included patients reported side effects.ConclusionsMirabegron is an effective treatment for children with therapy-refractory NLUTD with an average efficacy of 2 years after which additional therapy is required. Despite the retrospective character of this study, our results confirm the beneficial effect of mirabegron in children with therapy-refractory NLUTD, in particular when mirabegron is used as add-on therapy in those with low-compliance bladders.
Background: The diagnosis of a clinically significant catheter-associated urinary tract infection (CAUTI) in patients performing clean intermittent catheterization (CIC) or with an indwelling catheter (IC) can be challenging. Objective: To get an insight into the variation of the used definition, diagnosis and management of CAUTIs by relevant healthcare workers in the Netherlands. Design: An online clinical scenario-based survey. Methods: The survey was built in Limesurvey and distributed to healthcare workers from randomly selected urology departments, rehabilitation departments/centres and general practice offices between January and May 2022. Questions regarding their field of experience, management strategies, used guidelines and two hypothetical cases with clinical scenarios of a possible CAUTI were included. Results: A total of 172 individuals participated, of which 112 completed the survey. In all, 32 individuals who completed the survey partially were also included. Participants consisted of 68 [44 urologists, 22 rehabilitation doctors (RDs) and 2 general practitioners (GPs)] doctors, 60 nurses (46 from the urology department and 14 from rehabilitation centres/departments) and 16 medical assistants (13 from urology department and 3 from GP offices). The majority consulted patients with an IC or on CIC on a daily/weekly or monthly basis. In all, 35 urologists (79.5%), 9 RDs (40.9%), 21 (45.7%) nurses in the urology department and 6 (42.9%) nurses from a rehabilitation department/centre indicated bladder irrigation as a treatment option for prevention/treatment of CAUTIs, treatment of symptoms or treatment of blockage of the catheter. In the clinical scenarios presented, treatment discrepancies were seen between subspecialties and healthcare workers. Various guidelines were named for the definition of CAUTIs. Conclusion: A considerable variation in diagnoses and management of CAUTIs between the healthcare workers involved was seen. Uniformity in diagnosing and managing CAUTIs, to prevent overtreatment and possible resistance to antibiotics, is advised. Suitable multidisciplinary guidelines are preferred.
Introduction Catheter-associated urinary tract infection (CAUTI) is a common complication among patients with urinary catheters and is often treated with antibiotics. With increasing rates of antibiotic resistance, it is necessary to explore alternative treatment options for CAUTIs. The aims of this study were 1) to assess the efficacy and treatment satisfaction of bladder irrigation (BI) with tap water to prevent and treat CAUTIs, 2) and to evaluate the current use of BI for CAUTIs among Dutch clinicians. Methods The first part of this study consisted of a cross-sectional study among patients with intermittent or indwelling catheters who performed BI with tap water between March 2020 and May 2021. Efficacy, treatment satisfaction, and Patient Global Impression of Improvement (PGI-I) were assessed using questionnaires. Outcomes were compared between neurogenic lower urinary tract dysfunction (NLUTD) and non-NLUTD patients. Factors associated with overall treatment satisfaction were determined using logistic regression analysis. Second, a nationwide survey of Dutch clinicians was conducted to evaluate the current use of BI for CAUTIs. Results A total of 99 patients who were performing BI for at least three months were included. The median age was 61.9 years, 41.4% had NLUTD, and 72.2% performed BI >1 year. The majority of both NLUTD (65.9%) and non-NLUTD patients (68.4%) were (very) satisfied with BI. Women had higher odds of reporting higher satisfaction and each additional CAUTI decreased the odds. Most NLUTD (85.4%) and non-NLUTD (65.5%) patients reported an improvement on the PGI-I with a difference in favour of NLUTD patients (p=0.002). In addition, 40.4% of the patients had no CAUTI, and 59.6% reported 1.39 (SD 2.06) CAUTIs. Only half of these self-reported CAUTIs were treated with antibiotics. In addition, 33 (58.9%) clinicians used BI for CAUTIs, of which ten used tap water as irrigation agent. Discussion This study provides first evidence supporting the efficacy of BI with tap water in the treatment of CAUTIs and reducing the use of antibiotics. Patients are overall satisfied and experience improvement in their condition with BI. In addition, the majority of the surveyed Dutch clinicians use BI for CAUTIs. However, irrigation with tap water is still not widely used.
Objectives: Our aim was to evaluate trends and regional differences in the use of indwelling and intermittent urinary catheters in the community setting in the Netherlands from 2012 to 2021. Design and methods: For this population-based cohort study, data on catheter use was collected from the Drug and Medical Devices Information System of the National Healthcare Institute of the Netherlands. This database contains information on the Dutch insured population, which was 100% of the total population in 2018. Users were divided into 12 provinces according to the Nomenclature of Territorial Units for Statistics codes. The number of catheter users was adjusted for the total population of the provinces by sex and age, and was expressed by users per 100,000 people. Negative binomial regression (NBR) was used to test for differences in clean intermittent catheter (CIC) and indwelling catheter (IDC) users across Dutch provinces. Results: Between 2012 and 2021, IDC users increased by 44.6% from 41,619 to 60,172, and CIC users increased by 27.3% from 34,204 to 43,528. The greatest increases were mainly observed among IDC users over 85 years old and male CIC users over 65 years old. NBR showed significant differences for IDC and CIC users between the 12 provinces. CIC incidence was higher in Drenthe and Groningen (Northern Netherlands) compared to Zuid-Holland (Southern Netherlands). IDC incidence was higher in seven provinces dispersed throughout the Netherlands compared to Noord-Holland. Conclusion: CIC and IDC users have continued to increase in recent years; this was especially observed among older men. In addition, there were regional differences in the number of CIC and IDC users; CIC was more prominent in the northern region of the Netherlands, and IDC varied between multiple provinces. Practice variation in urinary catheterization may result from patient population differences or healthcare provider preferences and their alignment with guidelines.
Purpose The global prevalence of overactive bladder (OAB) is estimated at 11.8%. Despite existing treatment options such as sacral neuromodulation, a substantial number of patients remain untreated. One potential alternative is noninvasive transcutaneous electrical stimulation. This form of stimulation does not necessitate the implantation of an electrode, thereby eliminating the need for highly skilled surgeons, expensive implantable devices, or regular hospital visits. We hypothesized that alternative neural pathways can impact bladder contraction. Methods In this pilot study, we conducted transcutaneous electrical stimulation of the abdominal wall (T6-L1), the ear (vagus nerve), and the ankle (tibial nerve) of 3 anesthetized female Sprague-Dawley rats. Stimulation was administered within a range of 20 Hz to 20 kHz, and its impact on intravesical pressure was measured. We focused on 3 primary outcomes related to intravesical pressure: (1) the pressure change from the onset of a contraction to its peak, (2) the average duration of contraction, and (3) the number of contractions within a specified timeframe. These measurements were taken while the bladder was filled with either saline or acetic acid (serving as a model for OAB). Results Transcutaneous stimulation of the abdominal wall, ear, and ankle at a frequency of 20 Hz decreased the number of bladder contractions during infusion with acetic acid. As revealed by a comparison of various stimulation frequencies of the tibial nerve during bladder infusion with acetic acid, the duration of contraction was significantly shorter during stimulation at 1 kHz and 3 kHz relative to stimulation at 20 Hz (P = 0.025 and P = 0.044, respectively). Conclusions The application of transcutaneous electrical stimulation to the abdominal wall, ear, and tibial nerve could provide less invasive and more cost-effective treatment options for OAB relative to percutaneous tibial nerve stimulation and sacral neuromodulation. A follow-up study involving a larger sample size is recommended.
In this study, we investigated the effects of protein tyrosine kinase (PTK) and protein tyrosine phosphatase (PTP) on the tyrosine phosphorylation of N-methyl-D-aspartate receptor subunit 2A (NR2A) and the interactions among NR2A, postsynaptic density protein 95 (PSD-95), Fyn/Src after brain ischemia/reperfusion (I/R). The following results were observed: (1) the increase in tyrosine phosphorylation of NR2A induced by I/R was suppressed by genistein, an inhibitor of PTK, but was further enhanced by sodium orthovanadate, an inhibitor of PTP, which were administered to the SD rats 20 min before ischemia. (2) Importantly, genistein and sodium orthovanadate increased and decreased the interactions involving NR2A, PSD-95, Fyn and Src, respectively. These results demonstrated that PTK and PTP were involved in regulating tyrosine phosphorylation of NR2A through changing the interaction among NR2A, PSD-95, Fyn/Src.
Background: Urinary incontinence is a prevalent form of pelvic floor dysfunction, with a non-negligible impact on a patient’s quality of life. There are several treatment options, varying from conservative to invasive. The aim of this study is to predict treatment outcomes of pure or predominant urge urinary incontinence (UUI) in women to support shared decision-making and manage patient expectations. Methods: Data on patient characteristics, disease history, and investigations of 512 consecutive women treated for UUI in three hospitals in the Netherlands were retrospectively collected. The predicted outcome was the short-term subjective continence outcome, defined as patient-reported continence 3 months after treatment categorized as cure (no urinary leakage), improvement (any degree of improvement of urinary leakage), and failure (no improvement or worsening of urinary leakage). Multivariable ordinal regression with backward stepwise selection was performed to analyze association between outcome and patient’s characteristics. Interactions between patient characteristics and treatment were added to estimate individual treatment benefit. Discriminative ability was assessed with the ordinal c-statistic. Results: Conservative treatment was applied in 12% of the patients, pharmacological in 62%, and invasive in 26%. Subjective continence outcome was cure, improvement, and failure in 20%, 49%, and 31%, respectively. Number of incontinence episodes per day, voiding frequency during the day, subjective quantity of UI, coexistence of stress urinary incontinence (SUI), night incontinence, and bladder capacity and the interactions between these variables were included in the model. After internal validation, the ordinal c-statistic was 0.699. Conclusions: Six variables were of value to predict pure or predominant UUI treatment outcome in women. Further development into a comprehensive set of models for the use in various pelvic floor disorders and treatments is recommended to optimize individualized care. This model requires external validation before implementation in clinical practice.
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.
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.