Artificial Urinary Sphincter Research Articles

AUTHOR REPLY

AUTHOR REPLY

Immediate and Long-term Outcomes of Lateral Retroperitoneal Pressure Regulating Balloon Placement During Artificial Urinary Sphincter Implantation

ObjectiveTo describe immediate and long-term outcomes of pressure regulating balloon (PRB) placement, exchange, and extraction from the lateral retroperitoneum (LR) in male patients receiving an artificial urinary sphincter (AUS). MethodsA retrospective chart review was performed on all patients that underwent primary AUS placement between 2006 to 2021. All patients had the PRB placed in the LR during the study period. Intraoperative complications during PRB placement, exchange, or removal, and indications for PRB revision, such as infection, erosion, or mechanical failures were analyzed. Results541 patients were included in the study. All patients underwent primary implantation with no intraoperative complications including no incidents of bowel or vascular injury during PRB placement. In addition, there were no instances of intraoperative injury during PRB removal (with or without PRB replacement). After mean follow-up of 54.8 months (range: 1 – 181 months), 9 patients (1.7%) developed a reservoir-specific complication with infection (5 patients, 0.9%) being the most common issue found. The second most common type or reservoir issue was a palpable or herniated reservoir. There were 2 patients (0.4%) who herniated their reservoirs and one patient with a non-bothersome, but palpable reservoir. Lastly, there were 2 incidents (0.4%) of mechanical failure caused by a leak in the PRB. ConclusionDue to the ease and safety of placing and removing PRBs from this location and exceedingly low rates of PRB-related complications in long term follow-up, the LR should be considered as an ideal location for PRB placement in male patients receiving an AUS.

Androgens and Urethral Health: How Hypogonadism Affects Postoperative Outcomes of Patients Undergoing Artificial Urinary Sphincter or Inflatable Penile Prosthesis Placement

To determine the role of androgens in penile and urethral health, we sought to understand what impact hypogonadism may have on artificial urinary sphincter (AUS) and inflatable penile prosthesis (IPP) outcomes. We hypothesize that patients with hypogonadism are at increased risk of reinterventions, complications, and infections. We queried the TriNetX Global Database in March 2023 for patients receiving an AUS or IPP, looking at lifetime reintervention, complication, and infection rates. We conducted multiple comparisons: (1) eugonadal patients against hypogonadal patients, (2) hypogonadal patients on testosterone replacement therapy (TRT) against hypogonadal patients not on TRT, and (3) hypogonadal patients on TRT against eugonadal patients. Hypogonadal patients undergoing AUS had more complications (33.5% vs 28.3%), higher reintervention rates (27.7% vs 24.3%) and higher infection rates (7.3% vs 6.8%), albeit none reaching significance. Hypogonadal patients undergoing IPP had significantly higher infection rates (6.3% vs 4.4%, RR 1.5 (1.04, 2.04)) and reintervention rates (14.9% vs 11.9%, RR 1.3 (1.04, 1.61)), but not complication rates (21.9% vs 18.9%). When comparing patients with hypogonadism on TRT vs off TRT, there was not a significant difference in reinterventions, or complications, in AUS and IPP patients, but there were significantly more infections in IPP patients (7.0% vs 3.9%, RR 1.9 (1.002, 3.5)). Hypogonadal patients have more reinterventions, complications, and infections following urologic implant surgery, to varying levels of significance. TRT may not be completely protective to improve tissue health but with many limitations that should be explored in further research.

International multicenter retrospective study on high-risk patients who underwent artificial urinary sphincter (AUS) Implantation with Transcorporal versus Standard technique

International multicenter retrospective study on high-risk patients who underwent artificial urinary sphincter (AUS) Implantation with Transcorporal versus Standard technique

Urinary deversion as a last resort in patients with failed artificial urinary sphincter implantation

Urinary deversion as a last resort in patients with failed artificial urinary sphincter implantation

Which revision strategy is the best for non-mechanical failure of male artificial urinary sphincter?

Persistence or recurrence of stress urinary incontinence (prSUI) after artificial urinary sphincter (AUS) implantation may be secondary to non-mechanical failure (NOMECA). It have for long been assumed to result from urethral atrophy. Its existence is now debated. As the pathophysiology of NOMECA is not elucidated, the most appropriate management remains unclear. We aimed to compare the several revision techniques for NOMECA of AUS in men. NOMECA was defined as prSUI, with normally functioning device, no erosion, infection or fluid loss. Exclusion criteria were neurogenic SUI, revision or explantation for other causes. From 1991 to 2022, 143 AUS revisions for NOMECA, including 99 cuff DOWNSIZING, 10 cuff repositioning (RELOC), 13 TANDEM-CUFF placement, 18 cuff changing (CHANGE), three increasing balloon pressure (BALLOON-UP), were performed in 10 centers. BALLOON-UP patients weren't included in comparative analysis due to small sample size. All components could be changed during the revision. Patients were also categorized in COMPLETE-CHANGE vs. PARTIAL-CHANGE of the device. The three-months complete continence rate was 70.8% with a significant difference between RELOC and DOWNSIZING groups (p = 0.04). COMPLETE CHANGE was significantly associated with complete continence status at three months in multivariate analysis (83.3% vs.63.3%, OR = 2.7; CI 95% [1.1-7.1], p = 0.03). Estimated five-year reoperation-free and explantation-free survival were respectively 63.4% and 75.9% (p = 0.16; p = 0.30). Those were significantly longer in COMPLETE-CHANGE vs PARTIAL-CHANGE (82.2% vs.69.6%, p = 0.03); (71.2% vs. 58.2%, p = 0.047). AUS revision for prSUI due to NOMECA yields satisfactory outcomes regardless of the technique used. We observed better functional outcomes when repositioning the new cuff. COMPLETE-CHANGE may improve functional outcomes, explantation-free and reoperation-free survivals.

Characterizing and Quantifying Material Fatigue of the Artificial Urinary Sphincter Pressure Regulating Balloon

ObjectiveTo characterize and quantify changes in elastic properties and in vivo pressure characteristics of pressure regulating balloons (PRB) over time, we conducted an analysis of the mechanical characteristics of the PRB after removal from patients for revision surgery. MethodsPressure and elasticity characteristics of new and used 61-70cmH20 PRBs were analyzed. Pressure-volume curves were generated using commercially available urodynamics equipment. PRB pressures were measured at a standard fill volume (23cc). Elastance was calculated by the slope of the tangent line at the inflection point of the pressure-volume curve. Tests were repeated 5 times per PRB and intraclass correlations were used to gauge test-retest reliability. Regression models were used for continuous variables based on data distribution. ResultsTwenty-seven used PRBs were analyzed after excluding three for alternative pressure ratings and two for occult pinpoint leaks. Time from AUS placement to removal ranged from 0.02 to 17.6 years (median 8.4, IQR 5.7-10.0). The mean pressure of all extracted PRBs: 58.8cmH2O (±7.4), 17 (62.9%) below the standard operating range. Each year of use in-vivo was associated with 1.09cmH20 pressure loss on linear regression (p<0.01 CI -1.52 to -0.65). PRB pressures were not significantly different according to indication for removal (one-way ANOVA p=0.11). Loss of elastance was non-linear, decreasing by 1.9% per year on Poisson regression (p<0.01, CI -0.03 to -0.01). When accounting for PRB age, PRB pressure was independently associated with detrusor overactivity. ConclusionsIn PRBs tested for pressure-volume characteristics, increasing PRB age was associated with decreased pressure and elasticity.

Protocol for a systematic review and meta-analysis on preoperative risk factors for failure after fixed sling implantation for post-prostatectomy stress urinary incontinence

Background: Post-prostatectomy urinary incontinence (PPI) is a bothersome complication affecting patients undergoing prostate surgery that in up 10% of cases will require an invasive treatment with fixed slings or artificial urinary sphincters (AUS). Although fixed slings have several advantages over AUS, failure rates after slings range between 15% and 45% while current knowledge of predictors of sling efficacy remains limited. By systematically combining and summarizing all relevant literature, the present review and meta-analysis aim to address this research need assessing the association between preoperative risk factors and sling failure. Methods: Studies pertaining to fixed synthetic male perineal slings as treatment for adult male suffering from PPI, will be included. A systematic search will be conducted in PubMED, Scopus, Web of Science and Cochrane databases, and in the reference lists of retrieved articles. Independent reviewers will conduct study selection and data extraction. Outcomes will include failure to achieve the continence cure and overall success (cure plus improvement), measured as per included studies. Exposures will include any preoperative variables evaluated for association with sling failure. The QUIPS tool will be used for study quality assessment and a random-effects DerSimonian-Laird model, with Hartung-Knapp adjustment, will be used to pool adjusted and unadjusted odds ratios separately. Sensitivity analysis will be performed using the leave-one-out methodology and subgroup meta-analyses based on pre-specified studies’ characteristics will be conducted to explain the heterogeneity. Certainty of evidence will be assessed according to GRADE methodology and review reporting will comply with the PRISMA-P statement. Discussion: By summarising all relevant literature in the field, our results will help to incorporate available evidence into clinical practice assisting healthcare professionals managing PPI patients in treatment decision-making. The present review will also provide researchers with the necessary, evidence-based groundwork to perform future high-quality prognostic studies in the field. Registration: CRD42022307160.

An evaluation of three validated comorbidity indices to predict short-term postoperative outcomes after prosthetic urologic surgery.

Commonly used comorbidity indices include the Charlson Comorbidity Index (CCI), Elixhauser/Van Walraven Index (VWI), and modified frailty index (mFI). This study evaluates whether these indices predict postoperative readmissions and complications after inflatable penile prosthesis (IPP) and artificial urinary sphincter (AUS) placement. We identified adult males who underwent IPP or AUS placement using the State Inpatient and State Ambulatory Surgery and Services Databases for Florida (2010-2015) and California (2010-2011). CCI, VWI, and mFI scores were calculated for each patient. We extracted 30-day emergency department services, 30-day readmissions, 90-day device complications (e.g., removal, replacement, or infection), and 90-day postoperative complications (excluding device complications). Receiver-operating characteristic curves were constructed and areas under the curve (AUC) were compared between the indices using the VWI as the reference model. We considered an AUC < 0.7 to represent poor predictive power. We identified 4242 IPP and 1190 AUS patients. All three indices had AUCs and 95% confidence intervals less than 0.70 for all outcomes following IPP and AUS placement making these indices poor predictors for postoperative outcomes. There were no significant differences in predicting 90-day postoperative complications between the VWI (AUC = 0.59, 95% CI [0.54-0.63]), CCI (AUC = 0.59, 95% CI [0.54-0.63], p = 0.99), and mFI (AUC = 0.60, 95% CI [0.55-0.66], p = 0.53) for IPPs and VWI (AUC = 0.54, 95% CI [0.47-0.61]), CCI (AUC = 0.50, 95% CI [0.43-0.57], p = 0.30), and mFI (AUC = 0.52, 95% CI [0.43-0.60], p = 0.56) for AUS placements. All three comorbidity indices were poor predictors of readmissions and complications following urologic prosthetic surgeries. A better comorbidity index is needed for risk-stratification of patients undergoing these surgeries.

Evaluation and Revision of Artificial Urinary Sphincter Failure for Male Stress Urinary Incontinence

Evaluation and Revision of Artificial Urinary Sphincter Failure for Male Stress Urinary Incontinence

The 51-60 cm H2O Artificial Urinary Sphincter Pressure Regulating Balloon: Indications and Outcomes

To describe the role and long-term outcomes of using the 51-60 cm H2O pressure regulating balloon (PRB) in male patients with an artificial urinary sphincter (AUS). From 2005 to 2021, 90 patients with a variety of urethral risk factors underwent AUS placement with use of the low pressure 51-60 cm H2O PRB to treat stress incontinence. Patient demographics, indication for use of the 51-60 cm H2O PRB, perioperative data, and postoperative outcomes were examined and Pearson's chi squared test and Wilcoxon rank sum test were used to identify associations with future revisions, erosion, and mechanical failure. 90 patients were included in the study. After median follow-up of 46.6 months (range: 6 - 146 months), 4 (4.44%) patients developed an erosion-related complication that required device removal, 4 developed an infection, and 3 underwent surgery for pump relocation. One patient had a reported mechanical failure of unknown source. 30 patients underwent revision surgery to reduce incontinence. Of the 4 patients with erosion, 1 was due to iatrogenic catheterization. The remaining 3 had numerous urethral risk factors. Univariate analysis was performed to identify predictors of cuff erosion, infection, and revision in patients with a 51-60 cm H2O PRB. No significant associations were found including prior pelvic radiation, age at AUS placement, presence of IPP, prior AUS erosion, or previous urethroplasty. The low pressure 51-60 cm H2O PRB can be used in high-risk male patients with urinary incontinence with low rates of complications including erosion, infection, and mechanical failure. While patients may choose to undergo future revisional surgery to improve continence, the 51-60 cm H2O PRB should be considered as the initial PRB in patients with urethral risk factors.

Robot-assisted Periprostatic Artificial Urinary Sphincter Implantation in Men with Neurogenic Stress Urinary Incontinence: Description of the Surgical Technique and Comparison of Long-term Functional Outcomes with the Open Approach

BackgroundPeriprostatic artificial urinary sphincter implantation (pAUSi) is a rare yet relevant indication for male neurogenic stress urinary incontinence (SUI). ObjectiveTo describe the surgical technique of robot-assisted pAUSi (RApAUSi) and compare the long-term functional results with the open pAUSi (OpAUSi). Design, setting, and participantsData of 65 consecutive men with neurogenic SUI undergoing pAUSi between 2000 and 2022 in a tertiary centre were collected retrospectively. Surgical procedureThirty-three patients underwent OpAUSi and 32 underwent RApAUSi. OpAUSi cases were performed by a single surgeon, experienced in functional urology and prosthetic surgery. RApAUSi cases were performed by the same surgeon together with a second surgeon, experienced in robotic surgery. MeasurementsOutcome measures were achievement of complete urinary continence, intra- and postoperative complications, and surgical revision–free survival (SRFS). Results and limitationsRApAUSi showed superior results to OpAUSi in terms of median (interquartile range) operative time (RApAUSi: 170 [150–210] min vs OpAUSi: 245 [228–300] min; p < 0.001), estimated blood loss (RApAUSi: 20 [0–50] ml vs OpAUSi: 500 [350-700] ml; p < 0.001), and median length of hospital stay (LOS; RApAUSi: 5 [4–6] d vs OpAUSi: 11 [10–14] d; p < 0.001). Clavien-Dindo grade ≥3a complications occurred more frequently after OpAUSi (RApAUSi: 1/32 [3%] vs OpAUSi: 10/33 [30%]; p = 0.014). Achievement of complete urinary continence (zero pads) was comparable between the groups (RApAUSi: 24/32 [75%] vs OpAUSi: 24/33 [73%]; p = 0.500). The median follow-up periods were 118 (50–183) and 56 (25–84) mo for OpAUSi and RApAUSi, respectively (p < 0.001). A tendency towards longer SRFS was observed in the RApAUSi group (p = 0.076). The main study limitation was its retrospective nature. ConclusionsRApAUSi is an efficient alternative to OpAUSi, resulting in shorter operative times, less blood loss, fewer severe complications, and a shorter LOS with similar functional results and need for revision surgery. Patient summaryCompared with open periprostatic artificial urinary sphincter implantation (pAUSi), robot-assisted pAUSi leads to faster recovery and similar functional results, with fewer postoperative complications.

REtrospective Multicenter Observational study of immediate Voiding at End of Urinary Sphincter surgery [REMOVE

Patients may remain catheterized after Artificial Urinary Sphincter surgery to prevent urinary retention, despite a lack of evidence to support this practice. Our study aims to evaluate the feasibility of outpatient, catheter-free continence surgery using a multi-institutional database. We hypothesize that between catheterized controls and patients without a catheter, there would be no difference in the rate of urinary retention or postoperative complications. We conducted a retrospective review of patients undergoing first-time AUS placement from 2009-2021. Patients were stratified by postoperative catheter status into either no catheter (leaving the procedure without a catheter) or catheter (postoperative indwelling catheter for ∼24 hours). The primary outcome, urinary retention, was defined as catheterization due to subjective voiding difficulty or documented PVR over 250 mL. Our study identified 302 catheter and 123 no catheter patients. Twenty (6.6%) catheter and nine (7.3%) no catheter patients developed urinary retention (p=0.8). On multivariable analysis, controlling for age, cuff size, radiation history and surgeon there was no statistically significant association between omitting a catheter and urinary retention[OR:0.45(95%CI:0.13-1.58);p=0.2]. Furthermore, at 30 months follow up, Kaplan-Meier survival analysis revealed at device survival was 70% (95%CI:62-76%) vs. 69% (95%CI:48-82%) for the catheter and no catheter group, respectively. In our multi-institutional cohort, overall retention rates were low (7%) in groups with a catheter and without. Obviating postoperative catheterization facilitates outpatient incontinence surgery without altering reoperation over medium-term follow-up.

Guiding Clinical Decision Making for Surgical Incontinence Treatment After Prostatectomy: A Review of the Literature.

Stress urinary incontinence after prostatectomy is a common and debilitating side effect. Immediate post-prostatectomy management emphasizes pelvic floor muscle exercises. Per American Urologic Association guidelines, if incontinence persists for more than 12months postoperatively, surgical interventions are the mainstay of treatment. Treatment decisions depend on a multitude of factors. The goal of this paper is to review recent literature updates regarding the diagnosis of male SUI to better guide surgical treatment decision-making. Patient history is a critical component in guiding surgical decision making with severity and bother being primary factors driving treatment decisions. Recent studies indicate that a history of pelvic radiation continues to impact the overall duration and complication rate associated with artificial urinary sphincters (AUS). Cystoscopy should be done on every patient preparing to undergo surgical SUI treatment. Urodynamics and standing cough stress tests are additional diagnostic testing options; these tests may augment the diagnosis of SUI and better delineate which patients may benefit from a male sling versus AUS. Treatment of SUI after prostatectomy can improve health-related quality of life. A patient history focused on severity and degree of bother in addition to the use of ancillary office testing can help guide surgical treatment decisions to optimize patient continence goals.

Use of implants to treat male urinary incontinence

Treatments for benign and malignant pathologies of the prostate can compromise urine control. Urinary incontinence (UI) affects the quality of life of patients and limits their ability to carry out usual activities. The degree of impact of UI is variable and the associated discomforts make patients seek treatment for it. At the center of the management of urinary incontinence in men are surgical interventions that seek to replace the affected sphincter function through implants. The artificial urinary sphincter since its development in the 1970s has been considered the standard of treatment for UI in men. More recently artificial sphincter and slings have been shown to be effective in a selected group of incontinent men. The goals of surgical treatment of incontinence include the preservation of bladder function, the ability to improve the strength of the urinary sphincter, and to reduce or eliminate urine leakage, and thereby improve the quality of life. The aim of the article is to present various implants for the correction of male urinary incontinence.

The Role of Artificial Urinary Sphincter in Female Incontinence in 2023: A Literature Update

This in-depth analysis of the literature provides a 2023update on the crucial function of artificial urinarysphincters (AUS) in the treatment of femaleincontinence. This review illustrates the tremendousadvancements in AUS technology, particularly theintroduction of flexible cuff pressure and occlusive cufftechniques, which have considerably improvedtreatment outcomes and patient satisfaction. It drawson the most recent research from the last ten years.

Intravesical liposomal tacrolimus for hemorrhagic cystitis: a phase 2a multicenter dose-escalation study

BackgroundHemorrhagic cystitis (HC) is an inflammatory disease of the bladder with sustained hematuria for which there is currently no approved drug treatment. We evaluated a liposomal tacrolimus preparation (LP-10) in patients with refractory moderate to severe sterile HC.MethodsThis phase 2a dose-escalation study assessed the safety and efficacy of up to 2 intravesical instillations of LP-10 (2, 4, or 8 mg tacrolimus) in 13 patients with HC. Primary efficacy outcomes were changes from baseline in the number of bleeding sites on cystoscopy, microscopic urine analysis for red blood cells (RBCs), and hematuria on dipstick. Additional efficacy measures included urinary incontinence, frequency, and urgency on a 3-day diary and cystoscopy global response assessment (GRA). Blood samples for pharmacokinetic (PK) assessment were obtained in all patients.ResultsIntravesical LP-10 was well tolerated, with no treatment-related severe or serious adverse events (AEs) and only 3 drug-related AEs (artificial urinary sphincter malfunction, dysuria, and bladder spasms). LP-10 blood levels showed short durations of minimal systemic uptake. Treatment resulted in significant improvements in bleeding on cystoscopy, RBC counts in urine, hematuria on dipstick, and urinary incontinence. Bleeding on cystoscopy and urinary incontinence showed dose-dependent improvements that were more pronounced in the 4 mg and 8 mg dose groups. All dose groups showed a significant improvement in cystoscopy GRA.ConclusionLP-10 was well tolerated, with clinically relevant efficacy seen in improvements in cystoscopic bleeding, hematuria, and urinary incontinence. The benefit-risk profile supports the further clinical development of LP-10 at a tacrolimus dose of 4 mg.

A robot-assisted laparoscopic revision of an artificial urinary sphincter in a patient with spinal cord injury.

This step-by-step article demonstrates our approach to robot-assisted laparoscopic revision of a bladder neck sited artificial urinary sphincter (AUS) for a spinal cord injured patient. The bladder neck location of an AUS in the spinal cord injured demographic is ideal to minimise urethral complications and urinary tract infections, whilst the transabdominal approach reduces the risk of wound breakdown that can occur via the typical perineal incision for AUS insertion. The accompanying video will guide viewers as to our minimally invasive technique for cuff revision in the event of secondary surgery for recurrent urinary incontinence.

Urinary Artificial Sphincter in Male Stress Urinary Incontinence: Where Are We Today? A Narrative Review

Introduction: Urinary incontinence is a prevalent condition, especially in elderly men, with stress urinary incontinence (SUI) being a common cause after radical prostatectomy. The artificial urinary sphincter (AUS), particularly the AMS 800™ device, has been the gold-standard treatment for moderate-severe male SUI for decades. Despite some technical advancements and alternative devices like ZSI-375, Victo, and BR-SL-AS 904 being introduced, there is limited literature comparing their effectiveness to the AMS 800™. Methods: This literature review compares the AMS 800™ to the newer technologies in the management of SUI. We reviewed the current literature on urinary sphincter implant in male stress incontinence, including AMS 800™, ZSI-375, Victo, and BR-SL-AS 904. Findings: The AMS 800™ is a sophisticated system consisting of an inflatable cuff, a pressure-regulating balloon, and a control pump. Studies show continence rates ranging from 61% to 100% with AMS 800™ implants, with low infection rates and significant improvement in patients’ quality of life. The ZSI-375 sphincter is a unique single-piece cuff without an abdominal reservoir, simplifying implantation. Preliminary data show a social continence rate of 73% at six months, with lower complication rates than the AMS 800™. The VICTO® device offers adjustable pressure and a stress relief mechanism, providing conditional occlusion of the urethra. Early studies report a satisfaction rate of up to 94.2% and a complication rate of 17.6%. BR-SL-AS 904 is a newly proposed urinary sphincter, but due to the limited number of cases and a single study, its efficacy and complication rates remain uncertain. Conclusions: Overall, AMS 800™ remains the gold-standard treatment for SUI after radical prostatectomy. Alternative devices like ZSI-375 and VICTO® show promising results, but longer studies and more data are needed to establish their effectiveness and safety compared with the AMS 800™. Further research and ongoing monitoring are essential to address mechanical issues associated with AUS implants.

Artificial Urinary Sphincters for Moderate Post-Prostatectomy Incontinence: Current Research and Proposed Approach.

Male urinary incontinence is a common complication after radical prostatectomy. The severity of incontinence can be assessed in various ways and helps determine the best surgical intervention to restore continence. While most patients with mild incontinence receive a sling and those with severe incontinence receive an artificial urinary sphincter (AUS), there are no clear guidelines on how to manage patients with moderate post-prostatectomy incontinence (PPI). Our discussion will focus on the current literature, which demonstrates that an AUS should be considered first-line in men with moderate PPI despite perceived concerns over complications and reintervention rates.