Perspectives on technology: Single-use catheters - evidence and environmental impact.

OBJECTIVE: To explore the data comparing single- vs multi-use catheters for clean intermittent catheterisation (CIC), consider if the widespread use of single-use catheters is warranted given the cost and environmental impact, and put forth ideas for future consideration. METHODS: A primary literature review was performed in PubMed over the past 50 years. Studies that performed comparative analysis of single- and multi-use catheters were included in our review. All studies that reported on primary data were narratively summarised. RESULTS: A total of 11 studies were identified that reported on primary data comparing single- and multi-use catheters. There was no appreciable evidence suggesting reusable multi-use catheters were inferior to single-use catheters from an infection or usability standpoint. In addition, the environmental and monetary burden of single-use catheters is significant. CONCLUSIONS: The intermittent catheter landscape in the USA has a complex past: defined by policy, shaped by industry, yet characterised by a paucity of data demonstrating superiority of single-use over multi-use catheters. We believe that the aversion to reusable catheters by many patients and healthcare professionals is unwarranted, especially given the cost and environmental impact. Moving forward, better comparative data and more sustainable practices are needed.

Urodynamic and urethral pressure profilometry findings in women with voiding phase dysfunction treated with surgical urethrolysis.

INTRODUCTION: Long-term urodynamic (UDS) and urethral pressure profilometry (UPP) parameters in women with voiding phase dysfunction following an anti-incontinence (AI) procedure have been poorly characterized. We report our 10-year UDS findings in women with voiding phase dysfunction after AI procedure, who underwent urethrolysis. METHODS: We identified sequential records containing urethrolysis current procedural terminology codes over a 10-year period. Records of women with preoperative UDS were reviewed for demographics, UDS tracing, and outcomes following urethrolysis. RESULTS: Twenty-five women (mean age 60 years) had voiding phase dysfunction and underwent urethrolysis at a mean of 47 months (interquartile range [IQR] 12-61) after AI procedure. Preoperatively, six (24%) women required intermittent catheterization. Free uroflowmetry revealed a mean maximum peak flow (Qmax) of 9.6 ml/s (IQR 7.0-11.0), voided volume of 137 ml (IQR 81-169), and postvoid residual of 167 ml (IQR 43-288). UDS revealed a mean UPP length of 24 mm (IQR 20-27), UPP closure pressure of 78 cmH2O (IQR 59-103), detrusor pressure at maximum flow (Pdet@Qmax) of 31 cmH2O (IQR 19-43), Qmax of 7.9 ml/s (IQR 5.0-12.0), bladder outlet obstruction index of 15 (IQR 0-34), and bladder contractility index of 71 (IQR 60-81). UPP length was significantly associated (Pearson correlation, p<0.05) with bladder outlet obstruction index (r=0.80), Pdet@Qmax (r=0.75), and time since AI procedure (r=-0.70). UPP closure pressure was significantly associated with age (r=-0.64), volume of first (r=-0.64) and strong (r=-0.78) desire, and capacity (r=-0.71). Following urethrolysis, spontaneous voiding was achieved in 23 (92%) women at followup (mean 308 days). CONCLUSIONS: UPP may help characterize outlet parameters in women with voiding phase dysfunction following an AI procedure, who ultimately undergo urethrolysis.

Outcomes of Aquablation in Men With Acute and Chronic Urinary Retention.

OBJECTIVE: To compare outcomes of Aquablation in men with acute and chronic urinary retention. METHODS: We conducted a retrospective review of all men undergoing Aquablation resection of the prostate between May 2021 and August 2022. Men were classified as having acute urinary retention if they required either intermittent or indwelling catheter and chronic urinary retention if they had a postvoid residual >300 mL prior to surgery. We compared success rates and time to passage of trial without catheter as well as complication rates to those with no retention. RESULTS: A total of 113 men underwent Aquablation including 28 with acute retention and 16 with chronic retention. Failure of initial void trial was significantly higher in patients with preoperative urinary retention (40%) and chronic retention with postvoid residual >300 mL (12.5%) compared to those with no retention (7.2%, P < .001). Among men with acute and chronic retention 98% were voiding spontaneously at a mean 5months follow-up. There was no difference in utilization of postoperative prostate medications, complications, International Prostate Symptom Score or uroflowmetry among men with acute, chronic, or no retention. CONCLUSION: Aquablation is an effective method for treatment of men with urinary retention, with 98% achieving spontaneous voiding regardless of preoperative urodynamic findings. Men in acute retention prior to surgery were more likely to fail their initial void trial, which may support the recommendation for a delayed trial without catheter.

Determining patient preferences in the treatment of medication-refractory overactive bladder.

INTRODUCTION: Overactive bladder (OAB) is often suboptimally addressed by behavioral or pharmacological treatments. Less than 15% of patients choose to pursue advanced OAB therapy (sacral nerve stimulation [SNS], percutaneous tibial nerve stimulation [PTNS], and bladder onabotulinum toxin type-A [BTX-A]). We seek to better understand which factors are most important to patients when choosing a third-line therapy. METHODS/MATERIALS: We developed a conjoint analysis survey that included five attributes of the third-line options for OAB (SNS, PTNS, and BTX-A). We administered the survey to new patients with urinary incontinence at two institutions. A hierarchical Bayes random effects regression analysis was used to determine the relative importance of the attributes. A choice simulator was used to model which third-line treatment options patients preferred. We followed patients to see if they pursued their predicted treatment. RESULTS: A total of 108 patients completed the study of whom 89% were women. There was representation from all age groups. The most important attributes of decision-making were the frequency of future procedures, the risk of catheterization, and the need for a device. On market simulation, SNS was the preferred treatment option (47%), followed by PTNS (29%) and BTX-A (14%). Only 10% of patients did not find any treatment option acceptable. CONCLUSIONS: Frequent follow-up, risk of catheterization, and the need for a device were the most important attributes when making a decision on third-line OAB therapy. On market simulation, SNS is the preferred treatment for all age groups though the ultimate choice in third-line therapy may be affected by external factors.

Aquablation Treatment for Benign Prostate Hyperplasia: Current Standardized Procedure.

The following video Atlas summary reviews all technical elements of the standardized setup, robotic execution, aquablation procedure, and hemostasis for efficient rapid benign prostate hyperplasia treatment.

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

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

Sacral Nerve Stimulation in Parkinson's Disease Patients With Overactive Bladder Symptoms.

OBJECTIVE: To assess the efficacy, safety, and outcomes of sacral nerve stimulation (SNS) for Parkinson's disease (PD) patients with overactive bladder symptoms. METHODS: We retrospectively reviewed PD patients who underwent Stage I SNS. Demographics, urodynamic data, and baseline voiding function were analyzed. Efficacy and safety of treatment were determined by rate of progression to Stage II, explantation, and surgical revision. Long-term outcomes were assessed using voiding diaries and/or clinic notes. RESULTS: Sixty percent (9/15) experienced ≥50% improvement in urinary parameters and proceeded to Stage II. There was no significant difference in age, body mass index, comorbidities, PD disease duration, or levodopa equivalent daily dose between successful and nonsuccessful Stage I patients. However, 100% of female patients experienced Stage I success compared to 44% of male PD patients (P = .04). Individuals with >12-month follow-up experienced an average reduction of 6 voids/day. No patients required revision or explantation of their device at latest clinic follow-up (22.2 ± 7.8 months). Higher maximal urethral closure pressures, detrusor pressure at maximum flow rate (PdetQmax), post-void residual volume, and mean bladder outlet obstruction index were observed in the Stage I trial failures. CONCLUSION: At our institution, PD patients have a similar rate of progression to Stage II compared to the general population. SNS is an effective therapy that should be considered among the treatment options for PD patients with overactive bladder symptoms. Urodynamic parameters associated with obstruction may be predictive of SNS failure in PD patients and may help guide patient selection, however further studies are needed.

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

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

Statewide Success of Staged Sacral Neuromodulation for the Treatment of Urinary Complaints in California (2005-2011).

PURPOSE: Sacral neuromodulation (SNS) is approved by the Food and Drug Administration as a third-line treatment for refractory overactive bladder, idiopathic urinary retention, and fecal incontinence. Prior to implantation of an implantable pulse generator, all patients undergo a trial phase to ensure symptom improvement. The published success rates of progression from the test phase to permanent implant vary widely (range, 24% to >90%). We sought to characterize success rates using a statewide registry. METHODS: Using nonpublic data, we identified SNS procedures using the California Office of Statewide Planning and Development ambulatory surgery database from 2005 to 2011. A successful trial was defined as receiving a stage 2 generator implantation after trial lead placement. Multivariable logistic regression was performed to identify factors associated with staged success. RESULTS: During the study period, 1396 patients underwent a staged SNS procedure, with 962 (69%) subsequently undergoing generator placement. Successful trial rates were 72% for overactive bladder wet, 69% for urgency/frequency, 68% for interstitial cystitis, 67% for neurogenic bladder, and 57% for urinary retention. On multivariate logistic regression, only male sex (odds ratio, 0.51) and urinary retention [odds ratio, 0.54) were significantly associated with lower odds of success, whereas age, race/ethnicity, medical insurance, and placement at an academic or high-volume institution had no association. CONCLUSIONS: The "real world" success rates for staged SNS implantation in California are less than those observed by some academic centers of excellence but better than previously reported for Medicare beneficiaries. Successful trial rates for interstitial cystitis and neurogenic voiding dysfunction are similar to refractory overactive bladder.

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

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

The mechanical stop test and isovolumetric detrusor contractile reserve are associated with immediate spontaneous voiding after transurethral resection of prostate.

PURPOSE: To identify urodynamic factors associated with the mechanical stop test and immediate spontaneous voiding following transurethral resection of prostate (TURP). METHODS: We identified 90 men who underwent TURP over a 12-month period. Forty-three (mean age 68 years) underwent urodynamic evaluation prior to TURP. Isovolumetric detrusor contractile pressure (Piso) was obtained using the mechanical stop test during the voiding phase, and used to calculate detrusor contractile reserve (Pres = Piso - Pdet@Qmax). Primary outcome was spontaneous voiding after TURP. RESULTS: Preoperative catheter-free spontaneous voiding was present in 63% of men (27/43) with a urodynamic (mean ± SD): Qmax 6.2 ± 2.7 mL/s, Pdet@Qmax 102 ± 47 cmH2O, Piso 124 ± 49 cmH2O, Pres 22 ± 16 cmH2O, bladder outlet obstruction index (BOOI) 90 ± 49, and bladder contractility index (BCI) 132 ± 44. The remaining 16 catheter-dependent men demonstrated a urodynamic (mean ± SD): Qmax 3.6 ± 3.3 mL/s, Pdet@Qmax 87 ± 38 cmH2O, Piso 99 ± 51 cmH2O, Pres 10 ± 18 cmH2O, BOOI 82 ± 36, and BCI 106 ± 48. Following TURP, 67% of men voided spontaneously with their first void trial, and in receiver operator analysis of urodynamic measures (Pdet@Qmax, Piso, Pres, BOOI and BCI), only Pres was significantly associated with immediate spontaneous voiding after TURP (threshold Pres ≥ 9 cmH2O, AUC = 0.681, p = 0.035). CONCLUSIONS: In men who underwent TURP, a Pres ≥ 9 cmH2O was associated with immediate spontaneous voiding and may be easily incorporated into the postoperative pathway.

To stage or not to stage?-A cost minimization analysis of sacral neuromodulation placement strategies.

AIMS: Sacral neuromodulation (SNM) is a standard therapy for refractory overactive bladder (OAB). Traditionally, SNM placement involves placement of an S3 lead with 1-3 weeks of testing before considering a permanent implant. Given the potential risk of bacterial contamination during testing and high success rates published by some experts, we compared the costs of traditional 2-stage against single-stage SNM placement for OAB. METHODS: We performed a cost minimization analysis using published data on 2-stage SNM success rates, SNM infection rates, and direct reimbursements from Medicare for 2017. We compared the costs associated with a 2-stage vs single-stage approach. We performed sensitivity analyses of the primary variables listed above to assess where threshold values occurred and used separate models for freestanding ambulatory surgery centers (ASC) and outpatient hospital departments (OHD). RESULTS: Based on published literature, our base case assumed a 69% SNM success rate, a 5% 2-stage approach infection rate, a 1.7% single-stage approach infection rate, and removal of 50% of non-working single-stage SNMs. In both ASC ($17 613 vs $18 194) and OHD ($19 832 vs $21 181) settings, single-stage SNM placement was less costly than 2-stage placement. The minimum SNM success rates to achieve savings with a single-stage approach occur at 65.4% and 61.3% for ASC and OHD, respectively. CONCLUSIONS: Using Medicare reimbursement, single-stage SNM placement is likely to be less costly than 2-stage placement for most practitioners. The savings are tied to SNM success rates and reimbursement rates, with reduced costs up to $5014 per case in centers of excellence (≥ 90% success).

Outcomes of Sacral Nerve Stimulation for Treatment of Refractory Overactive Bladder Among Octogenarians.

OBJECTIVE: Sacral nerve stimulation (SNS) is an effective treatment for refractory overactive bladder (OAB). However, advanced age is often cited as a reason to avoid SNS in the elderly. This study evaluates the safety and efficacy of SNS for refractory OAB among our octogenarian population. METHODS: A retrospective review from a single institution was performed on all SNS lead placements from December 1998 to June 2017 for refractory OAB. Octogenarians were characterized as 80 years of age or older at the time of Stage I. Efficacy and safety were determined by the rate of progression to Stage II, subsequent need for multimodal therapy, and rate of surgical revision and explantation. All patients were followed for a minimum of 12 months. RESULTS: Of 374 patients in this study, 37 (9.9%) were octogenarians. There was no difference in gender, race, smoking history, or prior OAB treatment regimens between cohorts. The rate of progression to Stage II was 56.8% for octogenarians compared to 60.5% for nonoctogenarians (p = 0.66). The rate of surgical revision, explantation, and need for multimodal therapy did not differ between groups. Subgroup analysis of octogenarians did not reveal any significant differences between successful and nonsuccessful Stage I patients. CONCLUSIONS: The safety and efficacy of SNS was similar between cohorts. This result suggests that SNS is a safe and effective therapy that should be considered among the treatment options for refractory OAB in octogenarian patients. Further studies are needed to determine predictive factors of Stage I success in elderly patients.

Incontinence after Prostate Treatment: AUA/SUFU Guideline.

PURPOSE: Urinary incontinence after prostate treatment (IPT) is one of the few urologic diseases that is iatrogenic, and, therefore, predictable and perhaps preventable. Evaluation of the incontinent patient, risk factors for IPT, the assessment of the patient prior to intervention, and a stepwise approach to management are covered in this guideline. Algorithms for patient evaluation, surgical management, and device failure are also provided. MATERIALS AND METHODS: This guideline was developed using a systematic review from the Mayo Clinic Evidence Based Practice Center with additional supplementation by the authors. A research librarian conducted searches from 2000 to December 21st, 2017 using Ovid, MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Databases of Systematic Reviews. Additional references through 12/31/2018 were identified. RESULTS: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with IPT and the safe and effective management of the condition in both surgical and non-surgical contexts. Statements guiding the clinician on proper management of device failure are also included. CONCLUSION: Most patients who undergo radical prostatectomy (RP), and some patients who undergo radiation therapy (RT) or surgery for benign prostatic hyperplasia (BPH), will experience IPT. Although non-surgical options, such as pelvic floor muscle exercises (PFME), can hasten continence recovery, patients who remain incontinent at one-year post-procedure, or have severe incontinence at six months, may elect to undergo surgical treatment (e.g. artificial urinary sphincter). Prior to IPT surgery, the risks, benefits, alternatives, and additional likely procedures should be discussed with the patient.

First-in-human implantation of a mid-field powered neurostimulator at the sacral nerve: Results from an acute study.

INTRODUCTION: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. MATERIALS AND METHODS: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. RESULTS: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. CONCLUSIONS: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.

Transvaginal ultrasound guided trigone and bladder injection: A cadaveric feasibility study for a novel route of intradetrusor chemodenervation.

PURPOSE: OnabotulinumtoxinA (BTX) detrusor chemodenervation is an efficacious third-line treatment for overactive bladder. Despite high clinical efficacy rates for BTX injection, many patients refuse initial or repeat treatment due to the invasiveness of the cystoscopic route of delivery. We assess the feasibility of injecting the trigone and posterior bladder wall via a transvaginal route under ultrasound guidance using a human cadaveric model. MATERIALS AND METHODS: Eight de-identified anonymous fresh female deceased donor cadaver pelvises were placed in supine split leg position. A transvaginal ultrasound probe guided injections of India ink into the trigone in 3 sites and the posterior wall in 2 sites. Full thickness bladder biopsies were then obtained and histologic analysis was performed to confirm presence of India ink in the detrusor layer. RESULTS: The mean time from day of death was 11.0 days (range, 4.0-23.0 days). Three to five bladder biopsies were obtained per cadaver, for a total of 34 specimens (20 trigone, 14 posterior wall). Histologic analysis revealed presence of India ink within the detrusor layer in 8/8 (100.0%) of cadavers. The surgeon's perception of appropriate targeting under ultrasound guidance was confirmed in 8/8 cadavers (100.0%) involving the bladder trigone, and 7/8 (87.5%) involving the posterior wall. Of injections that were believed to have appropriately targeted the detrusor layer, 22/34 specimens (64.7%) demonstrated the presence of India ink under histologic analysis. CONCLUSIONS: Intradetrusor injection of the bladder trigone and posterior wall under transvaginal ultrasound guidance is feasible and has acceptable accuracy.