The impact of perioperative complications on favorable outcomes after artificial urinary sphincter implantation for post-prostatectomy incontinence

ABSTRACT Objective To investigate the effect of perioperative complications involving artificial urinary sphincter (AUS) implantation on rates of explantation and continence as well as health-related quality of life (HRQOL). Materials and methods Inclusion criteria encompassed non-neurogenic, moderate-to-severe stress urinary incontinence (SUI) post radical prostatectomy and primary implantation of an AUS performed by a high-volume surgeon (>100 previous implantations). Reporting complications followed the validated Clavien-Dindo scale and Martin criteria. HRQOL was assessed by the validated IQOL score, continence by the validated ICIQ-SF score. Statistical analysis included Chi (2) test, Mann-Whitney-U test, and multivariate regression models (p <0.05). Results 105 patients from 5 centers met the inclusion criteria. After a median follow-up of 38 months, explantation rates were 27.6% with a continence rate of 48.4%. In the age-adjusted multivariate analysis, perioperative urinary tract infection was confirmed as an independent predictor of postoperative explantation rates [OR 24.28, 95% CI 2.81-209.77, p=0.004). Salvage implantation (OR 0.114, 95% CI 0.02-0.67, p=0.016) and non-prostatectomy related incontinence (OR 0.104, 95% CI 0.02-0.74, p=0.023) were independent predictors for worse continence outcomes. Low visual analogue scale scores (OR 9.999, 95% CI 1,42-70.25, p=0.021) and ICIQ-SF scores, respectively (OR 0.674, 95% CI 0.51-0.88, p=0.004) were independent predictors for increased HRQOL outcomes. Perioperative complications did not significantly impact on continence and HRQOL outcomes. Conclusion Findings show postoperative infections adversely affect device survival after AUS implantation. However, if explantation can be avoided, the comparative long-term functional results and HRQOL outcomes are similar between patients with or without perioperative complications.

Proposal of a new way to evaluate the external sphincter function prior male sling surgey

ABSTRACT Objective: To propose a new way to objectively evaluate the external sphincter function prior to male sling surgery. Materials and Methods: We evaluated the pre-operative sphincter function throughout sphincter pressure at rest (SPAR) and sphincter pressure under contraction (SPUC) obtained throughout urethral profilometry profile (UPP) of 10 consecutive patients (age range, 54-79 years) treated with the retrourethral transobturator sling (RTS) for stress urinary incontinence (SUI) because of prostate surgery. The primary endpoint for surgery success rate was post-operative pad weight test. This was correlated to pre-operative pad test, RT, SPAR and SPUC. Post-operatively patients were classified as continent (no pad use) and those who still were incontinent. Results: Mean SPUC in the continent and incontinent group was respectively 188 + 8.8 (median 185.1, range 181 to 201) and 96.9 + 49.4 (median 109.9, range 35.6 to 163.6) (P = 0.008). Mean 24-hour pad test was 151 + 84.2gm (median 140, range 80 to 245) and 973 + 337.1gm (median 1940, range 550 to 1200) in post-operative continent and incontinent groups respectively (P = 0.008). The repositioning test (RT) was positive in all continent patients except one. The RT was also positive in three incontinence patients (false positive). In all post-operative continent patients SPUC was higher than 180cmH2O and pre-operative pad test was less than 245gm. Conclusions: SPUC seems to be a way for optimizing the sphincter evaluation as well to become a useful tool for patient selection prior to RTS surgery.

Técnica quirúrgica de la implantación de dispositivo ajustable transobsturador anti-incontinencia urinaria masculina tipo Atoms en una clínica de III nivel en Bogotá / Surgical Technique of the Implantation of Adjustable Masculine Transobsturador Anti-Incontinence Urinary Device Type Atoms in a Clinic of III Level in Bogotá

La prevalencia de incontinencia urinaria de esfuerzo (IUE) post-prostatectomía varía entre el 4% y el 50%, siendo más frecuente en pacientes que son llevados a prostatectomía radical. Es una condición que afecta la calidad de vida de los pacientes y presenta un impacto de grado variable de severidad. Existen diferentes opciones para el tratamiento de esa entidad, dentro de los cuales se encuentran: terapia de piso pélvico con biofeedback, fisioterapia, sistemas recolectores de orina, clamps peneanos, inyecciones periuretrales de materiales abultantes, esfínter urinario artificial (EUA) y cintas pubouretrales.[1] [2] El gold standard para la IUE es el EUA con tasa de éxito entre 50%­80%, no obstante, con una tasa de explante de hasta el 33%. Se han desarrollado otras alternativas con cintas pubouretrales las cuales han reportado una tasa de éxito hasta del 83%.[2] La principal limitante de esas alternativas en el manejo de la IUE, ha sido la necesidad de reajustar esos dispositivos con procedimientos quirúrgicos, exponiendo en repetidas ocasiones a los pacientes a los riesgos de anestesia y del procedimiento quirúrgico, situación que se ha tratado de mejorar con el dispositivo ATOMS®, introducido en Europa desde marzo del 2009, el cual ofrece la oportunidad de realizar tales ajustes en el consultorio.[3] La indicación para la colocación del ATOMS® es la IUE, sin tener claridad en su severidad, hasta en un 92,9% de las ocasiones, y usualmente son pacientes con antecedente de cirugías previas anti-incontinencia fallidas (34,3%). El tiempo quirúrgico promedio es de 47 minutos, entre 29 minutos a 112 minutos.[1]

Sling Surgery for Male Urinary Incontinence Including Post Prostatectomy Incontinence: A Challenge to the Urologist / 대한배뇨장애요실금학회지

The management of postprostatectomy urinary incontinence (PPI) is still challenging for urologists. In recent decades, various kinds of male sling system have been developed and introduced; however, they have not yet shown as good a result as that of artificial urinary sphincter (AUS). However, a male sling is still in an important position because patients have a high demand for sling implantation, and it can allow the avoidance of the use of mechanical devices like AUS. Recently, the male sling has been widely used in mild-to-moderate PPI patients; however, there are no studies that compare individual devices. Thus, it is hard to directly compare the success rate of operation, and it is impossible to judge which sling system is more excellent. It is expected that many sling options will be available in addition to AUS in the near future with the technological development of various male slings and the accumulation of long-term surgical outcomes. In that in patients with PPI, sling implantation is an option that must be explained rather than an option that need not be explained to them, this review would share the latest outcomes and complications.

Artificial Urinary Sphincter Cuff Size Predicts Outcome in Male Patients Treated for Stress Incontinence: Results of a Large Central European Multicenter Cohort Study / 대한배뇨장애요실금학회지

PURPOSE: The aim was to study the correlation between cuff size and outcome after implantation of an AMS 800 artificial urinary sphincter. METHODS: A total of 473 male patients with an AMS 800 sphincter implanted between 2012 and 2014 were analyzed in a retrospective multicenter cohort study performed as part of the Central European Debates on Male Incontinence (DOMINO) Project. RESULTS: Single cuffs were implanted in 54.5% and double cuffs in 45.5% of the patients. The cuffs used had a median circumference of 4.5 cm. Within a median follow of 18 months, urethral erosion occurred in 12.8% of the cases and was associated significantly more often with small cuff sizes (P<0.001). Multivariate analysis showed that, apart from cuff size (P=0.03), prior irradiation (P<0.001) and the penoscrotal approach (P=0.036) were associated with an increased erosion rate. Continence rate tended to be highest with median cuff sizes (4–5.5 cm). CONCLUSIONS: Apart from irradiation and the penoscrotal approach, small cuff size is a risk factor for urethral erosion. Results are best with cuff sizes of 4.5–5.5 cm.

Artificial Urinary Sphincter for Postradical Prostatectomy Urinary Incontinence — Is It the Best Option? / 대한배뇨장애요실금학회지

Male stress urinary incontinence (SUI) can undoubtedly reduce quality of life and promote personal distress and psychosocial alienation. The frequency of postprostatectomy urinary incontinence (PPI) counts on the characterization of urinary incontinence and the periods of patient follow-up. Operational therapeutics, for instance, urethral male slings and artificial urinary sphincters, are well-chosen as adequate and secure surgeries for male SUI in men with continual PPI when conservative treatment is ineffective. Over the former 2 decades, surgery has progressed regarding both operative approach and sling architecture. However, there are no guidelines about when surgery should be carried out and which is the most appropriate surgical option. In this review, we summarize recent advances in implantable devices for PPI and also discuss traditional surgical care. When we are planning the male PPI surgery, careful preoperative work-up should be performed and surgical method should be chosen according to the severity of the disease. Male sling is preferred in mild and moderate symptomatic patients with normal detrusor pressure and it is recommended to select traditional artificial urinary sphincter device in those with severe symptoms. It is expected that effective devices without adverse events will be developed with technical advances in near future.

Artificial sphincter "BR - SL - AS 904" in the treatment of urinary incontinence after radical prostatectomy: efficacy, practicality and safety in a prospective and multicenter study

ABSTRACT Purpose: The objective of the present study is to test the efficiency and practicality of a new artificial sphincter "BR - SL - AS - 904" in the control of urinary incontinence in post - PR patients and to evaluate their complications. Patients and Methods: Fifteen patients with incontinence after one year of radical prostatectomy were included prospectively. All patients underwent artificial urethral sphincter (AUS) implant "BR - SL - AS - 904" according to established technique. Independent variables such as free urinary flow, PAD weight test, ICIQ - SF score and urinary symptoms through the IPSS score were compared in different follow-up moments. Results: Patients submitted to AUS implantation did not present trans - operative or post - operative complications related to the surgical act such as: infection, hematoma, erosion or urinary retention. Device was inert to the body during the follow-up, showing an excellent adaptation of the patients, besides the easy handling. The mean age was 68.20 years 40% of the patients had systemic arterial hypertension, 6.7% diabetes mellitus, 6.7% were hypertensive and diabetic, 13.4% were hypertensive, had diabetes and hypercholesterolemia and 26.7% patients had no comorbidities. It was evidenced that the urinary flow peak during the follow-up remained stable. Decreased averages and median PAD weight test were 135.19 to 75.72 and 106.00 to 23.50, respectively. The IPSS score decreased and the quality of life increased (12.33 to 3.40 and 2.50 to 3.20 respectively). The ICQF - SF questionnaire score also showed a decrease, ranging from 16, 71 to 7.33. Conclusion: The artificial sphincter implant "BR - SL - AS 904" was reproducible, safe and effective in the control of urinary incontinence in post - PR patients.

Salvage surgical procedure for artificial sphincter extrusion

ABSTRACT Case Hypothesis: Surgical removal is the standard treatment for artificial sphincter extrusion. However in some specific situations is possible to maintain the prosthesis with good results. Case report: We report a 60 years old patient presenting sphincter pump extrusion one month after artificial urinary sphincter (AUS) AMS 800™ placement for treating post-radical prostatectomy urinary incontinence (PRPUI). He also had a penile pros- thesis implant one year before that was replaced in the same surgery the sphincter was implanted. As patient refused sphincter removal and there were no signals of active infection he was treated by extensive surgical washing with antibiotics and antiseptics. Pump was repositioned in the opposite side of the scrotum. Patient had good evolution with sphincter activation 50 days later. After 10 months of follow up, patient is socially continent and having regular sexual intercourse. Savage surgery may be an option in select cases of artificial sphincter extrusion. Promising future implications: Like in some patients with penile prosthesis some pa- tients with artificial sphincter extrusion can be treated without removing the device. This may be a line of research about conservative treatment of artificial sphincter complications.

Single perineal incision placement of artificial urinary sphincter with cadaveric correlation of sub-dartos pump placement

ABSTRACT Purpose We present a novel AUS implantation technique using a single perineal incision for single device placement or in combination with an inflatable penile prosthesis (IPP). Urinary and sexual dysfunction following the management of prostate cancer has a significant impact on the quality of life of our patients. While there are marginal changes in the prosthetic devices, we strive to reduce post-operative morbidity while maximizing efficacy. Materials and Methods We retrospectively reviewed the outcomes of 6 patients who underwent single perineal incision placement of a virgin AUS in 2014, 3 with simultaneous IPP placement. In all cases, the pressure regulating balloons (PRB) were placed in a high sub-muscular ectopic position and the pumps were placed into a sub-dartos pouch through the perineal incision, which was also validated using a cadaveric model. Results The mean patient age was 61 (SD, 7.5 years) with mean body mass index of 31 (SD, 5.9). The average pre-operative pad usage was 7.7 (SD 1.63) pads per day. The mean follow-up was 13.9 months (SD 9.45). Four out of the six patients reported utilizing ≤1 pad daily at follow-up. The one patient who was not initially dry required downsizing of his cuff to 3.5cm; the remaining patient was lost to follow-up. There were no identifiable perioperative or post-operative complications. Conclusions We present our initial report of using a single perineal incision for AUS implantation with a validated sub-dartos pump location, which is safe and effective for implantation of an AUS as a single or double implantation in well-selected patients.

Long-term results of the implantation of the AMS 800 artificial sphincter for post-prostatectomy incontinence: a single-center experience

ABSTRACT Objectives Report the long-term outcomes of the AMS 800 artificial sphincer (AS) for the treatment post-prostatectomy incontinence (PPI) in a single center in Brazil. Materials and Methods Clinical data from patients who underwent the procedure were retrieved from the medical records of individuals with more than 1 year of follow-up from May 2001 to January 2016. Continence status (number of pads that was used), complications (erosion or extrusion, urethral atrophy, and infection), malfunctions, and need for secondary implantation were evaluated. The relationship between complications and prior or subsequent radiation therapy (RT) was also examined. Results From May 2001 to January 2016, 121 consecutive patients underwent AS implantation for PPI at an oncological referral center in Brazil. At the last visit, the AS remained implanted in 106 patients (87.6%), who reported adequate continence status (maximum of 1 pad/day). Eight-two subjects (67.8%) claimed not to be using pads on a regular basis at the final visit (completely dry). Revision occurred in 24 patients (19.8%). Radiation therapy (RT) for prostate cancer following radical prostatectomy was used in 47 patients before or after AS placement. Twelve patients with a history of RT had urethral erosion compared with 3 men without RT (p=0.004). Conclusion Considering our outcomes, we conclude that AS implantation yields satisfactory results for the treatment of PPI and should remain the standard procedure for these patients. Radiation therapy is a risk factor for complication.

Coronary artery spasm as the probable cause of cardiac arrest immediately after the induction of spinal anesthesia: A case report

A 72-year-old man underwent spinal anesthesia for artificial urinary sphincter placement for urinary incontinence. After the block level was confirmed below T6, 1 g of cefotetan, which had not shown any reaction on skin test, was administered as a prophylactic antibiotic. The patient began complaining of chest discomfort and dyspnea shortly after injection. ST elevation appeared on the electrocardiogram and the patient's pulse could not be palpated. Accordingly, cardiopulmonary resuscitation was performed for 5 minutes; the patient recovered spontaneous circulation. The patient was diagnosed as experienced coronary artery spasm by coronary angiography with spasm test. Because coronary artery spasm can also develop in patients with no history of coronary artery disease and under spinal anesthesia, careful observation, suspicion of coronary artery spasm and prompt response to hemodynamic and electrocardiogram changes are necessary.

Artificial urinary sphincter revision for urethral atrophy: comparing single cuff downsizing and tandem cuff placement

ABSTRACT Objective To compare outcomes for single urethral cuff downsizing versus tandem cuff placement during artificial urinary sphincter (AUS) revision for urethral atrophy. Materials and Methods We identified 1778 AUS surgeries performed at our institution from 1990-2014. Of these, 406 were first AUS revisions, including 69 revisions for urethral atrophy. Multiple clinical and surgical variables were evaluated for potential association with device outcomes following revision, including surgical revision strategy (downsizing a single urethral cuff versus placing tandem urethral cuffs). Results Of the 69 revision surgeries for urethral atrophy at our institution, 56 (82%) were tandem cuff placements, 12 (18%) were single cuff downsizings and one was relocation of a single cuff. When comparing tandem cuff placements and single cuff downsizings, the cohorts were similar with regard to age (p=0.98), body-mass index (p=0.95), prior pelvic radiation exposure (p=0.73) and length of follow-up (p=0.12). Notably, there was no difference in 3-year overall device survival compared between single cuff and tandem cuff revisions (60% versus 76%, p=0.94). Likewise, no significant difference was identified for tandem cuff placement (ref. single cuff) when evaluating the risk of any tertiary surgery (HR 0.95, 95% CI 0.32-4.12, p=0.94) or urethral erosion/device infection following revision (HR 0.79, 95% CI 0.20-5.22, p=0.77). Conclusions There was no significant difference in overall device survival in patients undergoing single cuff downsizing or tandem cuff placement during AUS revision for urethral atrophy.

A new material to prevent urethral damage after implantation of artificial devices: an experimental study

ABSTRACT Objective To validate the application of the bacterial cellulose (BC) membrane as a protecting barrier to the urethra. Materials and Methods Forty female Wistar rats (four groups of 10): Group 1 (sham), the urethra was dissected as in previous groups and nothing applied around; Group 2, received a 0.7cm strip of the BC applied around the urethra just below the bladder neck; Group 3, received a silicon strip with the same dimensions as in group 2; Group 4, had a combination of 2 and 3 groups being the silicon strip applied over the cellulosic material. Half of the animals in each group were killed at 4 and 8 months. Bladder and urethra were fixed in formalin for histological analysis. Results Inflammatory infiltrates were more intense at 4 months at lymphonodes (80% Grade 2), statistically different in the group 2 compared with groups 1 (p=0.0044) and 3 (p=0.0154). At 8 months, all samples were classified as grade 1 indicating a less intense inflammatory reaction in all groups. In group 2, at 8 months, there was a reduction in epithelial thickness (30±1μm) when com-pared to groups 1 (p=0.0001) and 3 (p<0.0001). Angiogenesis was present in groups 2 and 4 and absent in group 3. In BC implant, at 4 and 8 months, it was significant when comparing groups 4 with 1 (p=0.0159). Conclusion BC membrane was well integrated to the urethral wall promoting tissue remodeling and strengthening based on morphometric and histological results and may be a future option to prevent urethral damage.

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

ABSTRACT 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.

Targeting Moderate and Severe Male Stress Urinary Incontinence With Adjustable Male Slings and the Perineal Artificial Urinary Sphincter: Focus on Perioperative Complications and Device Explantations / 대한배뇨장애요실금학회지

PURPOSE: To analyze perioperative complications and postoperative explantation rates for selected readjustable male sling systems and the perineal single-cuff artificial urinary sphincter (AUS) in a large, contemporary, multi-institutional patient cohort. METHODS: Two hundred eighty-two male patients who underwent implantation between 2010 and 2012 in 13 participating institutions were included in the study (n=127 adjustable male sling [n=95 Argus classic, n=32 Argus T], n=155 AUS). Perioperative characteristics and postoperative complications were analyzed. The explantation rates of the respective devices were assessed using the Fisher exact test and the Mann-Whitney U-test. A Kaplan-Meier curve was generated. Potential features associated with device explantation were analyzed using a multiple logistic regression model (P<0.05). RESULTS: We found significantly increased intraoperative complication rates after adjustable male sling implantation (15.9% [adjustable male sling] vs. 4.2% [AUS], P=0.003). The most frequent intraoperative complication was bladder perforation (n=17). Postoperative infection rates did not vary significantly between the respective devices (P=0.378). Device explantation rates were significantly higher after AUS implantation (9.7% [adjustable male sling] vs. 21.5% [AUS], P=0.030). In multivariate analysis, postoperative infection was a strong independent predictor of decreased device survival (odds ratio, 6.556; P=0.001). CONCLUSIONS: Complication profiles vary between adjustable male slings and AUS. Explantation rates are lower after adjustable male sling implantation. Any kind of postoperative infections are independent predictors of decreased device survival. There is no significant effect of the experience of the implanting institution on device survival.