Patient Perception of Physician Reimbursement by Medicare for Artificial Urinary Sphincter Placement.

INTRODUCTION: Patient perceptions of physician reimbursement commonly differ from actual reimbursement. This study aims to improve health care cost transparency and trust between patients, physicians, and the health care system by evaluating patient perceptions of Medicare reimbursement for artificial urinary sphincter (AUS) placement. METHODS: We identified patients who underwent AUS placement at a single institution from 2014 to 2023. After obtaining informed consent, we administered a telephone survey to ask patients about their perceptions of Medicare reimbursement for AUS surgery and the amount they felt the physician should be compensated. RESULTS: Sixty-four patients were enrolled and completed the survey. On average, patients estimated Medicare physician reimbursement to be $18,920, 25 times the actual average procedure reimbursement. Once informed that the actual amount was $757.52, 97% of respondents felt that the reimbursement was "somewhat lower" (13%) or "much lower" (84%) than what they considered fair. The average amount that patients felt the physician should be paid was $8,844, 12 times the actual average procedure reimbursement. Fifty-four percent of patients estimated their physician's reimbursement to be higher than what they later reported as being "fair," representing a presurvey belief that their physician was overpaid. CONCLUSIONS: Patient perceptions of physician reimbursement for AUS are vastly different than the actual amount paid. The discordance between patient perception and actual reimbursement could impact how patients view health care costs and the relationship with their provider.

Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT.

BACKGROUND: Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. OBJECTIVE: We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. DESIGN: This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. SETTING: The trial was set in 28 UK urological centres in the NHS. PARTICIPANTS: Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. INTERVENTIONS: We compared male synthetic sling with artificial urinary sphincter. MAIN OUTCOME MEASURES: The clinical primary outcome measure was men's reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). RESULTS: In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference -0.034, 95% confidence interval -0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of -15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months' follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. LIMITATIONS: Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. CONCLUSIONS: Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. FUTURE WORK: Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. TRIAL REGISTRATION: This trial is registered as ISRCTN49212975. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Leakage of urine associated with physical exertion (e.g. sporting activities, sneezing or coughing) is common in men who have undergone prostate surgery, but it is difficult to improve. Many men still leak urine 12 months after their prostate surgery and may continue to wear protective pads or sheaths. The most common operation to improve incontinence is implantation of an artificial urinary sphincter. An artificial urinary sphincter is an inflatable cuff that is placed around the urethra, the tube that drains urine from the bladder. The cuff is inflated and compresses the urethra to prevent leaking. When the man needs to pass urine, he must deflate the cuff by squeezing a pump placed in his scrotum, which releases the compression on the urethra and allows the bladder to empty. Recently, a new device, the male sling (made from non-absorbable plastic mesh), has been developed. The sling, which is surgically inserted under the urethra, supports the bladder, but, in contrast to the artificial sphincter, it does not need to be deactivated by a pump and, therefore, the patient does not need to do anything to operate it. A sling is also easier for the surgeon to insert than a sphincter. However, in some men, the sling does not provide enough improvement in incontinence symptoms and another operation, to place an artificial urinary sphincter, is needed. The aim of this study was to determine if the male sling was as effective as the artificial urinary sphincter in treating men with bothersome incontinence after prostate surgery. The study took the form of a randomised controlled trial (the gold standard and most reliable way to compare treatments) in which men were randomised (allocated at random to one of two groups using a computer) to either a male sling or an artificial urinary sphincter operation. We asked men how they got on in the first 2 years after their operation. Regardless of which operation they had, incontinence and quality of life significantly improved and complications were rare. A small number of men did require another operation to improve their incontinence, and it was more likely that an artificial urinary sphincter was needed, rather than another sling operation, if a male sling was not successful. Satisfaction was high in both groups, but it was significantly higher in the artificial urinary sphincter group than in the male sling group. Those who received a male sling were less likely than those who received an artificial urinary sphincter to say that they would recommend their surgery to a friend.

Evaluation of the 24-h pad weight test as continence rate assessment tool after artificial urinary sphincter implantation for postprostatectomy urinary incontinence: A Swedish retrospective cohort study.

AIM: Patient-reported pad-count as continence rate assessment tool after artificial urinary sphincter (AUS) implantation is common. However, lack of standardized continence definition using this method results in heterogeneous published efficacy outcomes. Data on 24-h pad weight tests (PWT) after primary AUS implantation for postprostatectomy urinary incontinence (PPUI) is scarce. Our aim was to evaluate the 24-h PWT as an efficacy assessment tool and correlate it to qualitative outcomes using validated questionnaires. METHODS: This retrospective, single center, follow-up cohort study, evaluated 180 patients who underwent primary AUS implantation for PPUI from 2005 to 2018. Voiding diaries, 24-h PWT, validated patient satisfaction and quality of life (QoL) questionnaires were collected pre-operatively and at 3-6 months postactivation, using the institution's Electronic Medical Records. RESULTS: The median preoperative and postoperative 24-h PWT values were 494 (interquartile range [IQR]: 304-780) and 7 (IQR: 0-25) g respectively with a significant improvement in urinary leakage of 489.5 g 99.1% (p < 0.001). Median preoperative and postoperative I-QoL results increased from 33.5 (IQR: 19.3-63.6) to 86.4 (IQR: 73.9-94.3) points, with a significant 52.9 points improvement in QoL (p < 0.001). Similarly, the median preoperative and postoperative ICIQ-SF values decreased from 20 (IQR: 17-21) to 5 (IQR: 3-9) points, showing a significant improvement of 15 points (p < 0.001). We also found a significant correlation between PWT and patient satisfaction. CONCLUSION: The 24-h PWT provides a reliable and objective assessment of continence rates, with a strong correlation to qualitative outcomes, after primary AUS implantation for PPUI. Its use could help reduce reported outcome heterogeneity across studies.

Future considerations in prosthetic urology.

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations.

Proof of concept: Exposing the myth of urethral atrophy after artificial urinary sphincter via assessment of circumferential recovery after capsulotomy and intraoperative pressure profiling of the pressure regulating balloon.

Purpose: Rate of continence after artificial urinary sphincter (AUS) placement appears to decline with time. After appropriate workup to exclude inadvertent device deactivation, development of urge or overflow incontinence, and fluid loss, many assume recurrent stress urinary incontinence (rSUI) to be secondary to nonmechanical failure, asserting urethral atrophy as the etiology. We aimed to characterize the extent of circumferential urethral recovery following capsulotomy and that of pressure regulating balloon (PRB) material fatigue in men undergoing AUS revision for rSUI. Materials and Methods: Retrospective review of a single surgeon database was performed. Cases of AUS removal/replacement for rSUI involving ventral subcuff capsulotomy and intraoperative PRB pressure profile assessments were identified. Results: The described operative approach involving capsulotomy was applied in 7 patients from November 2015 to September 2017. Mean patient age was 75 years. Mean time between AUS placement and revision was 103 months. Urethral circumference increased in all patients after capsulotomy (mean increase 1.1 cm; range 0.5-2.5 cm). Cuff size increased, remained the same, and decreased in 2, 3, and 2 patients, respectively. Six of 7 patients underwent PRB interrogation. Four of these 6 PRBs (66.7%) demonstrated pressures in a category below the reported range of the original manufacturer rating. Conclusions: Despite visual appearance to suggest urethral atrophy, subcuff capsulotomy results in increased urethral circumference in all patients. Furthermore, intraoperative PRB profiling demonstrates material fatigue. Future multicenter efforts are warranted to determine if capsulotomy, with or without PRB replacement, may simplify surgical management of rSUI with reductions in cost and/or morbidity.

A cost-utility analysis of artificial urinary sphincter versus AdVance male sling in post prostatectomy stress urinary incontinence: A publicly funded health care perspective.

AIMS: To investigate the long-term cost-utility of the artificial urinary sphincter (AUS) compared with Transobturator Retroluminal Sling (AdVance) in the treatment of patients with severe post prostatectomy stress urinary incontinence (PPSUI) from a Canadian provincial health perspective. METHODS: A Markov model with Monte Carlo simulation was developed with a cycle length of 1 year and time horizon up to 10 years to estimate the incremental cost per quality-adjusted life years (QALYs). Patients were assigned to treatment with either AUS or an AdVance sling. Transition probabilities, efficacy data, and utility indices were derived from published literature and expert opinion. Cost data were obtained from provincial health care system and hospital data in 2016-Canadian dollars. The primary outcome was cost per quality-adjusted life year. A standard discount rate of 1.5% was applied annually. Probabilistic and one way deterministic sensitivity analyses were performed. RESULTS: AUS implantation had a 10-year mean total cost of $14 228 (SD ± 3,509) for 7.58 QALYs. AdVance sling had a mean total cost $18 938 (SD ± 12,435) for 6.43 QALYs. The incremental cost savings of AUS over 10-years was -$ 4710 with an added effectiveness of 1.15 QALYs. At a willingness to pay threshold of $50 000, AUS remained the most cost-effective option. A limitation of our analysis is the lack of direct long-term comparisons between both scenarios along with standard success definition. CONCLUSIONS: AUS implantation appears to be more economical treatment strategy for severe PPSUI compared with AdVance sling for a publicly funded health care system over a 5- and 10-year time horizon.

Analysis of cost of component replacement versus entire device replacement during artificial urinary sphincter revision surgery.

AIM: To identify the costs of replacing an entire malfunctioning AUS device versus an individual component at the time of device malfunction. METHODS: Decision analysis was performed by analyzing the costs associated with revising a malfunctioning artificial urinary sphincter using one of two techniques: either individual or entire device replacement. Costs were determined by including actual institutional costs. Model assumptions were based on a summary of published literature and were created based on a time horizon of 0-5 years since the original, primary AUS was placed, and models were created for malfunction of each individual component. Sensitivity analysis was done adjusting for costs of the device and failure rates. RESULTS: Total costs to replace an individual component were $8330 for the pump, $7611 for the cuff, and $5599 for the balloon, while entire device replacement cost $15 069. Over a 5-year time horizon the cost per patient for replacement of a balloon, pump, or cuff were $14 407, $17 491, and $15 212, respectively, versus $18 001 if the entire device was replaced. To be less costly to replace the entire device, balloon, pump, and cuff failure rates would need to be >55%, >25%, or >37.5% during the first 2 years after placement. CONCLUSION: In the event of failure of the artificial urinary sphincter, cost analysis demonstrates that removal and replacement of the entire device is more expensive than replacement of a malfunctioning component at any point up to 5 years after initial AUS placement.

Patterns and timing of artificial urinary sphincter failure.

PURPOSE: To assess population-based trends in artificial urinary sphincter (AUS) placement after prostatectomy and determine the effect of timing on device survival and complications. METHODS: We identified patients who underwent prostatectomy and AUS placement in SEER-Medicare from 2002 to 2011. We analyzed factors affecting the time of reoperation from AUS implantation and prostatectomy using multivariable Cox proportional hazard models. RESULTS: In total, 841 men underwent AUS placement at a median 23 months after prostatectomy. Patients who underwent reoperation (28.5%) had higher clinical stage, more likely underwent open prostatectomy, or had prior sling placement (p < 0.03). There were no differences in rates of diabetes, smoking status, prior radiation therapy, or Charlson Comorbidity Index between those requiring reoperation vs. not (all p > 0.15). Patients with AUS placement > 15 months after prostatectomy (75%) initially experienced less need for operative reinterventions. Patients with later AUS placement were significantly more likely to have received radiation therapy [22.9 vs. 3.8% (p < 0.01)]. Nonetheless, late implantation was confirmed to be protective on multivariate analysis during the first 5 years after AUS placement [HR 0.79 (95% CI 0.67-0.92); p < 0.01]. Factors independently associated with a shorter interval time until reoperation included history of radiation [HR 1.93 (95% CI 1.33-2.80); p < 0.01] and history of prior sling [HR 1.70 (95% CI 1.08-2.68); p = 0.02]. Even for patients who underwent radiation therapy, delayed AUS implantation reduced reoperative risk. CONCLUSIONS: Late AUS implantation in the Medicare population is associated with prolonged device survival initially, while radiation and prior sling surgery predict for earlier reoperation. Patients with delayed AUS implantation experience less immediate complications. Further work is required to identify patient-specific factors which may explain variability in timing for AUS.

Artificial urinary sphincter for urinary incontinence after radical prostatectomy: a historical cohort from 2004 to 2015.

This study aimed to retrospectively evaluate a cohort of patients with prostate cancer and persistent urinary incontinence after radical prostatectomy. From January 2004 to December 2015, eighty-six individuals were identified to have received an AUS implant, provided by a private nonprofit HMO operating in Belo Horizonte, Brazil. On total, there were 91 AUS implants, with a median interval between radical prostatectomy and AUS implant of 3.6 years (IQR 1.9 to 5.5). The rate of AUS cumulative survival, after a median follow-up of 4.1 years (IQR 1.7-7.2 years), was 44% (n=40). The median survival of AUS implants was 2.9 years (IQR 0.5-7.9 years). Thirty-seven AUS implants (40.7%) resulted in grade III surgical complications. There were 5 deaths at 2.1, 4.7, 5.7, 5.7 and 6.5 years of follow-up, but none due to causes directly associated to the AUS implant. Persistent severe incontinence was documented in 14 (15.3%) additional patients. From the 51 AUS implants which resulted in grade III surgical complications or persistent severe incontinence, 24 (47.1%) underwent surgical revisions. Explantation of the sphincter or its components was observed in 6 cases (25.0%). Mechanical failure, described as fluid loss and/or inability to recycle the AUS device, was observed in 4 devices (16.7%). In conclusion, although AUS implants are recommended as the gold-standard treatment of severe urinary incontinence after prostatectomy, the observed high rates of malfunction and grade III adverse events are a matter of concern warranting further assessment on the safety and efficacy of these devices.

Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up.

PURPOSE: to assess the efficacy of transcorporal artificial urinary sphincter (AUS) implantation on continence for male stress urinary incontinence in cases of prior surgical treatment or/and radiation failure, and as a first option in radiation patients. MATERIALS AND METHODS: From March 2007 to August 2012, 37 male patients were treated with transcorporal AUS AMS™ 800. Twelve patients had primary placement of transcorporal cuff, a surgical option due to a previous history of radiation and 25 patients had secondary procedure after failure of AUS or urinary incontinence surgery. Functional urinary outcomes were assessed by daily pad use, 24-hour Pad-test and ICIQ-SF questionnaire. Quality of life and satisfaction were assessed based on I-QoL and PGI-I questionnaires. RESULTS: After a median of 32 months, the continence rate (0 to 1 pad) was 69.7%. Median pad test was 17.5g (0-159), mean ICIQ-SF score was 7.3/21 (±5.4) and mean I-QoL score was 93.9/110. A total of 88% of the patients reported satisfaction with the AUS. The 5-year actuarial revision-free for AUS total device was 51%. Patients for primary implant for radiation were not more likely to experience revision than non-radiation patients. Preservation of erections was reported in half of the potent patients. CONCLUSIONS: Transcorporal AUS cuff placement is a useful alternative procedure option for severe male UI treatment, especially in patients with a compromised urethra after prior surgery or radiation. A high continence rate was reported and implantation as first option in radiation patients should be considered.

Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up

ABSTRACT Purpose to assess the efficacy of transcorporal artificial urinary sphincter (AUS) implantation on continence for male stress urinary incontinence in cases of prior surgical treatment or/and radiation failure, and as a first option in radiation patients. Materials and Methods From March 2007 to August 2012, 37 male patients were treated with transcorporal AUS AMS™ 800. Twelve patients had primary placement of transcorporal cuff, a surgical option due to a previous history of radiation and 25 patients had secondary procedure after failure of AUS or urinary incontinence surgery. Functional urinary outcomes were assessed by daily pad use, 24-hour Pad-test and ICIQ-SF questionnaire. Quality of life and satisfaction were assessed based on I-QoL and PGI-I questionnaires. Results After a median of 32 months, the continence rate (0 to 1 pad) was 69.7%. Median pad test was 17.5g (0-159), mean ICIQ-SF score was 7.3/21 (±5.4) and mean I-QoL score was 93.9/110. A total of 88% of the patients reported satisfaction with the AUS. The 5-year actuarial revision-free for AUS total device was 51%. Patients for primary implant for radiation were not more likely to experience revision than non-radiation patients. Preservation of erections was reported in half of the potent patients. Conclusions Transcorporal AUS cuff placement is a useful alternative procedure option for severe male UI treatment, especially in patients with a compromised urethra after prior surgery or radiation. A high continence rate was reported and implantation as first option in radiation patients should be considered.

National study of utilization of male incontinence procedures.

AIMS: We explored re-interventions and short and long term adverse events associated with procedures for male incontinence among Medicare beneficiaries. METHODS: All inpatient and outpatient claims for a simple random sample of Medicare beneficiaries for 2000-2011 were queried to identify patients of interest. All male patients with an International Classification of Diseases, 9th Edition (ICD-9) diagnosis code for stress incontinence or mixed incontinence were included. Artificial urinary sphincter recipients, patients who underwent a sling operation and those receiving an injection of a bulking agent were identified with Current Procedure Terminology (CPT-4) and ICD-9 Procedure Codes. RESULTS: The entire cohort of 1,246 patients were operated on between 2001 and 2011. 34.9% of them received an artificial urinary sphincter (AUS), 28.7% with a bulking agent, and 36.4% with a sling. There were no statistically significant differences in demographics or comorbidities between the treatment groups, except that more sling patients were obese (P = 0.006) and fewer bulk patients had diabetes (P = 0.007). There are, however, significant changes in procedures selected over time (P < 0.001). In the first year and over the entire follow-up after surgery, patients treated with bulking agents had the most subsequent interventions (40.1% and 52.9%), followed by sling (10.4% and 15.5%), and AUS (2.3% and 20%) (P < 0.001). Post-operative and 90 day complications were low. CONCLUSIONS: All three treatments seem to be safe among Medicare beneficiaries with multiple comorbidities. The urological, infectious, and neurological complication occurrences were low.

High submuscular placement of urologic prosthetic balloons and reservoirs: 2-year experience and patient-reported outcomes.

OBJECTIVE: To present our updated experience and patient-reported outcomes of high submuscular (HSM) placement of urologic prosthetic balloons and reservoirs (UPBRs). METHODS: A retrospective review was performed of patients who underwent inflatable penile prosthesis and/or artificial urinary sphincter placement between 2011 and 2013. UPBRs were placed in an HSM location between the transversalis fascia and the rectus abdominis muscle by blunt dissection through the external inguinal ring via a trans-scrotal approach. Patient demographics, perioperative outcomes, and patient-reported outcomes were reviewed. RESULTS: During the study period, 146 patients received 158 HSM implants: inflatable penile prosthesis reservoirs (n = 93) or artificial urinary sphincter balloons (n = 65). Patients completed a standardized survey at a mean of 3.2 months (range, 1.1-23.4 months) after surgery and were last followed up at a mean of 5.5 months (range, 1.1-28.7 months). Overall, 94% (n = 149) of UPBRs caused no bother, and patients were satisfied with 96% (n = 151) of implants. Patients were unable to palpate 80% (n = 126) of UPBRs and minimally palpate 16% (n = 26). The primary surgeon was unable to palpate 72% (n = 115) of UPBRs and minimally palpate 20% (n = 31). Type of UPBR, body mass index, reservoir volume, and reservoir manufacturer were not associated with patient or surgeon palpability. Of the 158 UPBRs placed, only 2 (1.3%) were revised due to bothersome patient palpability. No bowel, bladder, ureteral, or vascular injuries occurred. CONCLUSION: HSM placement of UPBR is safe and feasible, well tolerated, and avoids deep retropubic dissection. Patient-reported outcomes support low palpability, low bother, and high patient satisfaction.

Esfíncter urinário artificial na incontinência urinária masculina grave pós-prostatectomia / Artificial urinary sphincter in severe male urinary incontinence after prostatectomy

Demandante: American Medical System, INC - EUA. Tipo: Produto, dispositivo implantável cirurgicamente. Nome comercial: AMS 800. N° de registro na ANVISA: 80219980027. Validade do registro: 28/12/2014. Indicação de uso e finalidade do produto na ANVISA: incontinência urinária grave Indicação proposta: incontinência urinária grave pós-prostatectomia radical em pacientes com câncer de próstata. Descrição da Tecnologia: O esfíncter urinário é um dispositivo implantável de elastômero de silicone sólido, cheio de líquido, utilizado para tratar a incontinência urinária, restabelecendo o processo natural de controle urinário. O dispositivo simula a função esfincteriana normal ao abrir e fechar a uretra sob o controle do paciente. É composto por três componentes interligados: uma manga oclusora, uma bomba e um balão regulador da pressão. Os três componentes estão ligados por tubos resistentes a dobras. Considerações finais: A análise da evidência disponível sobre o implante de esfíncter urinário artificial e opções terapêuticas como slings e injeções, para o manejo de incontinência urinária moderada a grave, permitem uma abordagem indireta da efetividade comparativa dessas técnicas. Em relação ao uso de injeções de preenchimento, não parece ser uma terapia adequada para incontinência moderada a grave, pois praticamente não foi estudada e, no único estudo teve efetividade baixa. Com base nas informações disponíveis, o esfíncter artificial e os slings parecem ser terapias efetivas no manejo de incontinência urinária moderada a grave pós-prostatectomia radical para o tratamento do câncer de próstata. Em pacientes com sintomas moderados, ambas as estratégias parecem ter efetividade similar, tendo em vista a sobreposição dos intervalos de confiança das estimativas da meta-análise de cada terapia. Por outro lado, para casos com sintomas graves, o EA parece ter um benefício adicional em melhora dos sintomas e cura (intervalos de confiança não se cruzam). A análise econômica demonstrou que a alternativa de tratamento usual para incontinência urinária (medidas comportamentais e medicamentos) apresentou-se como a tecnologia menos custosa, mas também menos efetiva. Já a relação custo-efetividade das comparações entre as tecnologias esfíncter urinário e sling, parece estar relacionada ao grau de gravidade da incontinência urinária. Nos cenários de incontinência moderada e moderada/grave, o sling foi dominante, sendo mais efetivo e de menor custo do que o esfíncter artificial. Para o cenário de incontinência grave, não houve dominância, porém a RCEI do esfíncter quando comparado ao sling foi bastante alta. Diante do exposto, e por considerar a necessidade prévia de elaboração de um protocolo clínico e diretrizes terapêuticas (PCDT) para a linha de cuidado da incontinência urinária antes da incorporação isolada de tecnologias para essa condição, os membros da CONITEC, presentes na 12ª reunião ordinária do plenário dos dias 05 e 06/02/2013, recomendaram, por unanimidade, a não incorporação no SUS do esfíncter urinário artificial para tratamento da incontinência urinária masculina grave pós-prostatectomia. A Portaria nº 22, de 23 de maio de 2013 - Torna pública a decisão de não incorporar o esfíncter urinário artificial para o tratamento da incontinência urinária masculina grave pós-prostatectomia no Sistema Único de Saúde (SUS).

The impact of an antibiotic coating on the artificial urinary sphincter infection rate.

PURPOSE: In April 2008 InhibiZone® antibiotic coated artificial urinary sphincters were introduced. The antibiotic coating significantly increased the cost of the device by an average of $1,300 per artificial urinary sphincter. To our knowledge, no clinical data to date support the theory that this antibiotic coating decreases the risk of artificial urinary sphincter infection. Therefore, we compared infection rates in our cases before and after the introduction of InhibiZone coated artificial urinary sphincters to determine whether the coating decreased the device infection rate. MATERIALS AND METHODS: We retrospectively reviewed the records of 426 consecutive patients in whom an artificial urinary sphincter was implanted by a single surgeon from January 2005 to June 2012. Patients were divided equally into 213 consecutive males who received an artificial urinary sphincter without the antibiotic coating from January 2005 to March 2008 and 213 consecutive males implanted with the antibiotic coated artificial urinary sphincter from April 2008 to June 2012. Demographics and infection rates were compared. RESULTS: Patient mean age, associated comorbidities and complexity were almost identical in the groups with and without the antibiotic coating, and infection rates were identical at 7 patients (3.3%) per group (p = 0.99). In the more complex patient subgroup with revision the antibiotic coating did not impact the infection rate. Infection developed in 2 of 50 patients (5%) with the antibiotic coated device and in 3 of 38 (6%) with the uncoated device (p = 0.42). CONCLUSIONS: The InhibiZone coating of the artificial urinary sphincters did not alter the infection rate in our study. The added cost of the antibiotic coated artificial urinary sphincters (total of approximately $276,000 more for all 213 coated devices) was of no benefit in our series. Based on this assessment, we will transition to using artificial urinary sphincters without InhibiZone in our practice.

Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery.

BACKGROUND: Incontinence after prostatectomy for benign or malignant disease is a well known and often a feared outcome. Although small degrees of incidental incontinence may go virtually unnoticed, larger degrees of incontinence can have a major impact on a man's quality of life.Conceptually, postprostatectomy incontinence may be caused by sphincter malfunction and/or bladder dysfunction. The majority of men with post-prostatectomy incontinence (60 to 100%) have stress urinary incontinence, which is the complaint of involuntary urinary leakage on effort or exertion, or on sneezing or coughing. This may be due to intrinsic sphincter deficiency and may be treated with surgery for optimal management of incontinence. Detrusor dysfunction is more common after surgery for benign prostatic disease. OBJECTIVES: To determine the effects of surgical treatment for urinary incontinence related to presumed sphincter deficiency after prostate surgery for either benign LUTS secondary to BPH (transurethral resection of prostate (TURP), photo vaporization of the prostate, laser enucleation of the prostate and open prostatectomy) or radical prostatectomy for prostate cancer (retropubic, perineal, laparoscopic, or robotic). SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Register (searched 28 June 2010), MEDLINE (January 1966 to January 2010), EMBASE (January 1988 to January 2010), LILACS (January 1982 to January 2010) and the reference lists of relevant articles, handsearched conference proceedings and contacted investigators to locate studies. SELECTION CRITERIA: Randomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery. DATA COLLECTION AND ANALYSIS: Two authors independently screened the trials identified, appraised quality of papers and extracted data. MAIN RESULTS: Only one study with 45 participants met the inclusion criteria. Men were divided in two subgroups (minimal or total incontinence) and each group was randomized to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. In the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (OR 5.67, 95% CI 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the confidence intervals were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUTHORS' CONCLUSIONS: The evidence available at present is limited because only one small randomised clinical trial was identified. Although the result is favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.

An adjustable continence therapy device for treating incontinence after prostatectomy: a minimum 2-year follow-up.

OBJECTIVE: To evaluate the efficacy and safety of the ProACT (Uromedica, Inc., MN, USA) balloon device, an alternative for the surgical management of incontinence after prostatectomy. PATIENTS AND METHODS: The initial patients who received this device at our institution were evaluated, using urodynamics at baseline and at 6 months. Perioperative variables were recorded and pad usage, volume adjustments, an estimate of Incontinence Quality of Life (I-QoL) and adverse events were recorded at baseline, and 1, 3, 6, 12 and 24 months after surgery. RESULTS: In all, 37 patients were treated on this protocol between November 2001 and March 2005. Of these, 30 had had radical prostatectomy and seven holmium laser enucleation of the prostate. The mean (range) pad usage decreased from 2.81 (1-12) at baseline to 0.7 (0-4) pads at 24 months, and the I-QOL increased from 49.7 (4.5-77) to 81.3 (13.6-100) over the same period. At 24 months, 62% of 34 men were pad-free and 81% required one pad or less. Bilateral explantation was required in three patients (11%) for infection (one) and balloon migration (two). All other adverse events were mild and transient. CONCLUSIONS: The ProACT balloon device is an acceptable therapy for the surgical management of incontinence after prostatectomy.

Cost and time benefits of dual implantation of inflatable penile and artificial urinary sphincter prosthetics by single incision.

OBJECTIVES: To evaluate the efficiency, safety, and cost-effectiveness of synchronous prosthetic treatment of male urinary incontinence and impotence using a single transverse scrotal incision. METHODS: A total of 92 inflatable penile prostheses (IPPs), 21 artificial urinary sphincters (AUSs), and 15 combined IPPs/AUSs were implanted in 128 men at Brooke Army Medical Center and the University of Texas Health Science Center at San Antonio. The operative times and outcomes were compared among three groups (group 1, IPP; group 2, AUS; and group 3, dual IPP/AUS). We performed cost estimates of synchronous versus two-stage implant procedures. RESULTS: Dual implantation in a single-stage procedure significantly reduced (24.7%) the operative time (P <0.05, mean 113 minutes) compared with the total time for the individual procedures (IPP, average of 78 minutes; AUS, average of 72 minutes; total 150 minutes). No prosthetic infections or erosions occurred in this series. Dual implantation was associated with approximately a $7000 cost savings compared with individual procedures. CONCLUSIONS: The results of our study have shown that dual prosthetic implantation through a single incision is safe, efficient, and cost-effective.