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.

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.

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.

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.

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.

The cost of a catheter: An environmental perspective on single use clean intermittent catheterization.

METHODS: We estimated the prevalence of CIC use in the United States using a neurogenic population, consisting of persons with multiple sclerosis, spina bifida, and spinal cord injury. We measured catheter samples to obtain the amount of waste per catheter. RESULTS: At least 300 800 persons in the United States perform CIC for neurogenic bladder management. Assuming five catheterization events per day, the amount of waste generated by single-use CIC is between 26 500 to 235 400 pounds or 22 600 to 564 000 liters per day, depending on catheter model. CONCLUSIONS: Single-use CIC may generate up to 85 million pounds or 206 million liters of waste annually, equivalent to more than 26 000 cars or 80 Olympic-sized swimming pools. Laid end-to-end, there is enough catheter length circumscribe the world more than 5.5 times. The most common materials used in catheter construction have little to no degradation once in a landfill. Given the unproven clinical benefit of single-use catheterization, the environmental impact and alternatives should be considered.

Volitional Voiding of the Bladder after Spinal Cord Injury: Validation of Bilateral Lower Extremity Motor Function as a Key Predictor.

PURPOSE: In many individuals with spinal cord injury a return of volitional bladder voiding is considered more important than regaining motor function. Recently a predictive model using only composite bilateral lower extremity motor scores for levels L2-S1 (range 0 to 50) was proposed by the EMSCI (European Multicenter Study about Spinal Cord Injury) group. The model showed exceptional predictive power with an AUC of 0.912. We sought to further validate the EMSCI model in a national spinal cord injury cohort. MATERIALS AND METHODS: We created models of volitional voiding using the United States NSCID (National Spinal Cord Injury Database) for 2007 to 2016. In addition to testing lower extremity motor scores, we evaluated other patient variables that we hypothesized might affect volitional voiding. RESULTS: Volitional voiding was present in 1,333 of the cohort of 4,327 individuals (30.8%) at 1-year followup. While younger age, female gender, increased sacral sparing, improved AIS (American Spinal Injury Association Impairment Scale) classification and a more caudal sensory level predicted volitional voiding, lower extremity motor scores were most predictive (AUC 0.919). Adding the other patient characteristics did little to improve model performance (full model AUC 0.932). Further analysis of the predictive power of lower extremity motor scores suggested that while the AUC appeared to decrease in persons who were most likely to void volitionally, the performance of the predictive model remained outstanding with a combined AIS C and D AUC of 0.792. CONCLUSIONS: Our study verifies the validity of the EMSCI predictive model of volitional voiding after spinal cord injury. The differing performance of lower extremity motor scores in various AIS classifications should be noted.

Does the Degree of Cystocele Predict De Novo Stress Urinary Incontinence After Prolapse Repair? Further Analysis of the Colpopexy and Urinary Reduction Efforts Trial.

INTRODUCTION: Cystoceles may cause urethral obstruction by altering the vesicourethral angle. Restoration of normal anatomy after pelvic organ prolapse (POP) repair can relieve this obstruction but may unmask stress urinary incontinence (SUI). The association between the severity of cystocele and developing de novo SUI after prolapse repair, however, is poorly understood. We hypothesized that, in women undergoing prolapse repair, increasing degrees of bladder prolapse would be associated with increasing rates of postoperative de novo SUI. MATERIALS AND METHODS: We performed a secondary analysis of the Colpopexy and Urinary Reduction Efforts (CARE) trial data. Using the control arm (women undergoing prolapse repair without a prophylactic SUI procedure), we identified de novo SUI using a composite definition based on original trial criteria. We performed logistic regression to evaluate the relationship between the degree of cystocele and the development of new SUI. RESULTS: Of the 164 women who underwent abdominal sacrocolpopexy alone, 54% developed de novo postoperative SUI. Stratifying by the degree of anterior prolapse (point Ba), we found a linear increase in the rate of SUI with worsening preoperative cystocele. The incidence of de novo SUI based on the POP Quantification stage of anterior prolapse was 41.3%, 52.5%, and 66.1%, for stage 2, early stage 3, and advanced stage 3 or stage 4, respectively. Point Ba was found to be significantly associated with de novo SUI on both univariate (odds ratio = 1.17, P = 0.015) and multivariate analysis (odds ratio = 1.16, P = 0.04). CONCLUSIONS: The incidence of de novo SUI after prolapse repair directly correlates to the degree of cystocele on preoperative examination. This simple yet novel relationship should further guide discussions about potential postoperative incontinence.

Urodynamics of men with urinary retention.

OBJECTIVES: To describe the urodynamic characteristics of men with urinary retention, and to show the diverse treatment plans based on urodynamic findings. METHODS: We carried out a 3-year retrospective review of men with urinary retention who were referred to our clinic for urodynamic evaluation. Men with a history of neurogenic voiding dysfunction or major pelvic surgery were excluded. Multichannel videourodynamic studies were carried out, and the subsequent treatment modality offered was recorded. RESULTS: A total of 67 men with urinary retention and a median age of 68 years underwent urodynamic evaluation. The median maximum flow rate was 3 mL/s, and the median detrusor pressure at maximum flow was 54 cm H2 O. Bladder outlet obstruction was diagnosed in 60%. Detrusor underactivity was present in 73% according to the bladder contractility index; however, just 29% were classified as having detrusor underactivity according to isometric detrusor pressure, an alternative measure of contractility. A total of 76% of patients had low detrusor reserve (<20 cm H2 O). Based on urodynamic findings, just 57% of patients were offered de-obstructive surgery. CONCLUSIONS: In the present cohort, just 60% of men with urinary retention showed urodynamic evidence of bladder outlet obstruction. Depending on how contractility is measured (bladder contractility index vs isometric detrusor pressure), the rate of detrusor underactivity varies. The majority of men with retention had a low detrusor reserve. Given the wide spectrum of urodynamic findings in men with retention, surgical intervention might not be necessary for all. Furthermore, a careful consideration of urodynamics can assist in the selection of optimal treatment.

A Systematic Approach to the Evaluation and Management of the Failed Artificial Urinary Sphincter.

In men with post-prostatectomy incontinence, persistent or recurrent urinary leakage following artificial urinary sphincter placement is a frustrating complaint. Surgical failure can be classified as occurring early in the post-operative period vs. late-following a period of established continence-and should be managed according to the time course and severity of urinary leakage. We present a systematic approach for the evaluation and treatment of the failed artificial urinary sphincter. After considering the patient's individualized treatment goals and impact on quality of life, the clinician can more appropriately advise patients on a management strategy for their recurrent or persistent urinary incontinence following artificial urinary sphincter placement.