Artificial Sphincters to Manage Urinary Incontinence: A Review.

Urinary incontinence affects more than 300 million people worldwide. The implantation of a medical device called an artificial urinary sphincter (AUS) is the gold standard treatment when conservative and minimally invasive therapies fail. In this article, the AUSs (extra-urethral and endo-urethral sphincters) available on the market, both presented at the research level and filed as patents, are reviewed. The ability of the different solutions to effectively replace the natural sphincter are discussed, together with advantages and some possible side effects, such as tissue atrophy, overall invasiveness of the implant, and so forth. Finally, future research priorities are discussed for both endo-urethral and extra-urethral approaches considering key engineering aspects, such as materials, compression and closure mechanisms, and implantation methods, with the long-term aim of developing an effective, reliable, durable, and minimally invasive AUS capable of restoring a normal quality of life for incontinent patients.

Systematic review of surgical treatment of post radical prostatectomy stress urinary incontinence.

Context Stress urinary incontinence (SUI) after radical prostatectomy (RP) continues to be a significant problem with several implications including patient quality of life and other critical postoperative outcomes. Objectives To report the results in terms of efficacy (pad count, 24 hr pad test, QOL questionnaires) and safety (complication rate and type of complications) of all surgical devices approved for the treatment of SUI after RP. Evidence Acquisition A systematic review was conducted in accordance with the PRISMA Statement. A literature search was carried out through the PubMed/Medline, SCOPUS, and Web of Science databases using the keywords "incontinence," "radical prostatectomy," and "'treatment". Inclusion criteria were: number of patients higher than 30, mean follow up longer than 12 months and definition of a successful outcome as the use of 0 to 1 safety pads a day. Evidence Synthesis 113 papers underwent primary review. 51 papers met the inclusion criteria with a total sample size of 4022 patients. Efficacy (0-1 safety pads) was on average 65.7% for AUS, 48.2% for Invance Sling, 48.8% for Advance Sling, 64.2% for ProACT. Twenty four hour pad test and QOL questionnaires were respectively available only in 4 and 18 studies. The overall complication rate was 19.43% for AUS, 7.4% for Invance Sling, 12.3% for Advance Sling, 12.3% for ProACT. Authors' Conclusions Due to the poor overall quality of available studies, it was impossible to identify or refute clinically important differences between the alternative surgical procedures. Although our data seems to suggest that AUS has the highest efficacy in the treatment of SUI following RP it is also associated with the highest complication rate, but this may be due to the longest follow up. Larger rigorous trials are needed in order to support this evidence. Neurourol. Urodynam. 35:875-881, 2016. © 2015 Wiley Periodicals, Inc.

Radical cystectomy and ileal orthotopic bladder substitution after radical retropubic prostatectomy: functional and oncological results.

Men with good functional results following radical retropubic prostatectomy (RRP) and requiring radical cystectomy (RC) for subsequent bladder carcinoma seldom receive orthotopic bladder substitution. Four patients aged 62-72 years (median 67 years), who had undergone RRP for prostate cancer of stage pT2bN0M0 Gleason score 6 (n = 1), pT2cN0M0 Gleason score 5 and 6 (n = 2) and pT3bN0M0 Gleason score 7 (n = 1) 27 to 104 months before, developed urothelial bladder carcinoma treated with RC and ileal orthotopic bladder substitution. After radical prostatectomy three were continent and one had grade I stress incontinence, and three achieved intercourse with intracavernous alprostadil injections. Follow-up after RC ranged between 27 and 42 months (median 29 months). At the 24-month follow-up visit after RC daily urinary continence was total (0 pad) in one patient, two used one pad for mild leakage, and one was incontinent following endoscopic incision of anastomotic stricture. One patient died of progression of bladder carcinoma, while the other three are alive without evidence of disease. The three surviving patients continued to have sexual intercourse with intracavernous alprostadil injections. Men with previous RRP have a reasonable chance of maintaining a satisfactory functional outcome following RC and ileal orthotopic bladder substitution.

Orgasm-associated incontinence (climacturia) after bladder neck-sparing radical prostatectomy: clinical and video-urodynamic evaluation.

INTRODUCTION: Orgasm-Associated Incontinence (OAI) or climacturia has been observed in male patients maintaining sexual potency after radical prostatectomy and cystectomy. AIM: We investigated the incidence and video-urodynamic aspects of this event in continent and potent patients after bladder neck-sparing (BNS) radical prostatectomy (RP). MAIN OUTCOME MEASURE: Comparing functional and morphological aspects between climacturic and non-climacturic patients to identify a possible explanation of this unusual kind of leakage that could seriously impact the sexual life after surgery. METHODS: In a pool of 84 men, potent and continent at least 1 year after BNS RP, 24 (28.6%) reported climacturia and 7 agreed to undergo video-urodynamic evaluation (group 1), which was performed also in 5 controls (group 2). Those 12 men were also evaluated with 24-hour pad test, 5-item International Index of Erectile Function and International Prostate Symptom Score questionnaires. RESULTS: Functional urethral length (FUL) was significantly lower in the climacturia group (P=0.02) and time to continence recovery was significantly longer (P=0.05). No other significant differences were found between the two groups. The radiological appearance of the vesicourethral junction at voiding cystourethrography was similar. CONCLUSIONS: To the best of our knowledge, this is the first functional and morphological evaluation of climacturia after RP. In our experience, this event is indirectly associated with a reduced FUL in the sphincter area, although both patients and controls were continent during daily activities. BNS technique seems to reduce time to continence recovery, although climacturic patients need longer time than control patients. Since in our series no rigidity of the vesicourethral anastomosis was radiographically evident, we believe that differences in FUL could explain OAI. Anatomical difference in membranous urethra length could explain the occurrence of this symptom in patients treated with the same surgical technique.

Urethral Bulking in the Treatment of Stress and Mixed Female Urinary Incontinence: Results from a Multicenter Cohort and Predictors of Clinical Outcomes.

The aim of the present study is to analyze the outcomes of urethral bulking in the treatment of non-neurogenic female stress and mixed urinary incontinence and to assess predictors of clinical outcomes. We retrospectively included all consecutive patients affected by stress or mixed urinary incontinence and treated with urethral bulking. Outcomes were evaluated via the PGI-I questionnaire and the 24-h pad test. Between January 2010 and January 2020, we treated 216 patients (Bulkamid n = 206; Macro-plastique n = 10). The median age at surgery was 66 years (IQR 55−73.75). The median follow-up was 12 months (IQR 12−24). In total, 23.8% of patients were subjected to prior incontinence surgery, 63.8% of patients were affected by genuine stress urinary incontinence, 36.2% reported mixed urinary incontinence, whereas detrusor overactivity was confirmed in only 24.9%. The dry rate was 32.9%; nevertheless, 69.9% of patients declared themselves "very improved" or "improved" (PGI-I1-2). Low complications were observed, mostly classified as Clavien I. After univariate and multivariate analyses, the only statistically significant independent predictor of "dry" outcome was the 24 h pad test, p < 0.001. Urethral bulking could be proposed with more expectations of success in patients with mild urinary incontinence. Patients affected by moderate−severe incontinence are less likely to obtain clinical success; therefore, they should be carefully counselled about clinical expectations before the procedure.

Can urethral re-bulking improve the outcomes of a prior urethral bulking?

AIMS: To analyze the outcomes of urethral re-bulking in the treatment of female stress urinary incontinence. MATERIALS AND METHODS: We performed a multicenter observational retrospective study, which included all consecutive patients treated with urethral re-bulking for the treatment of persistent stress or mixed urinary incontinence after a previous urethral bulking. Objective outcomes were evaluated with the 24 h pad-test, while PGI-I questionnaires were administered to evaluate subjective outcomes. Clinical outcomes were assessed before re-bulking procedure and at last follow-up. Mann-Whitney's U test was used for subgroup analysis. Shapiro-Wilk's tests were used as normality tests. RESULTS: In total, 62 patients who underwent urethral re-bulking between 2013 and 2020 in a multicenter setting were included. Most patients did not reach complete continence after the first procedure (n = 56) while the remainder reported recurrence of urinary incontinence after initial benefit. Median age at surgery was 66 (IQR: 55-73). Median overall follow-up was 30 months (IQR: 24-41). Median time occurred between the first procedure and reintervention was 12 months (IQR: 7-27). Bulking agents for the re-bulking procedures were bulkamid(n = 56), macroplastique(n = 4), and Prolastic(n = 2). A statistically significant reduction of median 24 h pad test from 100 g(IQR: 40-200) to 35 g(IQR: 0-120) was observed (p = 0.003). Dry rate after rebulking was 36.6%, while 85.4% patients declared themselves 'very much improved' or 'much improved' (PGI-I 1-2). Very few low-grade complications were observed (n = 4). A single case of major complication occurred. CONCLUSIONS: Urethral re-bulking can be an effective technique for the treatment of stress urinary incontinence refractory to a previous urethral bulking and can determine a cumulative benefit after the first procedure.

When should we use urodynamic testing? Recommendations of the Italian Society of Urodynamics (SIUD). Part 1 - Female population.

Although, until a few years ago, the diagnostic power of urodynamic testing had never been questioned, recent studies in the literature have raised some doubts on the routine use of this tool. The benefits of the urodynamic studies (UDS) should be weighted against costs, time-consumption and patient discomfort. These recommendations are intended to guide clinicians in the right selection of the female patients to submit to a urodynamic evaluation. We reviewed the literature, regarding the use of UDS in female adults with lower urinary tract symptoms (LUTS) and pelvic floor dysfunction. Specifically, we analyzed and compared the guidelines and recommendations of the most important urology and uro-gynecology international scientific societies. These publications were used to create the evidence basis for characterizing the recommendations to perform urodynamic testing. A panel of 10 experts was composed and Delphi process was followed to obtain the panelist consensus. The final recommendations were approved by the unanimous consensus of the panel and compared with the best practice recommendations available in the literature. The recommendations are provided for diagnosis and management of common LUTS in female population. This review provides a summary of the most effective utilization of urodynamic studies for the global evaluation of patients with lower urinary tract symptoms and how to use them when really needed, avoiding unnecessary costs and patient inconveniences.

When should we use urodynamic testing? Recommendations of the Italian Society of Urodynamics (SIUD). Part 2 - Male and neurogical population.

Recent studies in literature, have raised some doubts on the routine use of urodynamic testing. Many physicians and articles recommend a selective use of this tool, considering carefully risks and benefits. These recommendations are intended to guide clinicians in the right selection of the male and neurological patients to submit to a urodynamic evaluation. This is the second part of a previous article regarding the urodynamic recommendations in the female population. We reviewed the literature, regarding the use of UDS in male and neurological population with lower urinary tract symptoms (LUTS). Specifically, we analyzed and compared the guidelines and recommendations of the most important urology and urogynecology international scientific societies. These publications were used to create the evidence basis for characterizing the recommendations to perform urodynamic testing. A panel of 10 experts was composed and Delphi process was followed to obtain the panelist consensus. The final recommendations were approved by the unanimous consensus of the panel and compared with the best practice recommendations available in the literature. The recommendations are provided for diagnosis and management of common LUTS in male and neurological population. This review provides a summary of the most effective utilization of urodynamic studies for the global evaluation of patients with LUTS, and how to use them when really needed, avoiding unnecessary costs and patient inconveniences.

Bladder pressure measurement in a critically ill patient: report of a case.

Elevated intra-abdominal pressure has been recognized as a cause of significant morbidity and mortality in critically ill patients, exerting a considerable impact on organ function. Early detection and adequate treatment have been identified as essential measures to prevent the development of abdominal compartment syndrome. We present a case of early abdominal decompression with signs of organ failure in a patient with elevated intra-abdominal pressure measured by urinary bladder pressure.

Could the sling position influence the clinical outcome in male patients treated for urinary incontinence? A magnetic resonance imaging study with a 3 tesla system.

OBJECTIVE: To analyze the morphologic changes visible on magnetic resonance imaging (MRI) after sling procedure in continent patients and to compare MRI findings with the incontinent ones, to detect possible factors explaining the different clinical outcomes. METHODS: Twenty-seven male patients who were treated with Advance sling for urinary stress incontinence after prostate surgery were enrolled: 16 had clinical recovery, whereas 11 had persistent incontinence. Patients after sling were defined as continent if used 0-1 dry "security pad" or incontinent >1 pad. Magnetic Resonance examinations were performed with a 3 Tesla system and included 3-dimensional T2-weighted sequence. Three readers performed a qualitative (representation of the bulb and indentation of the sling) and a quantitative analysis (length of the bulb posterior to the sling and distance of the sling from a line bisecting the pubic symphysis). RESULTS: The sling was clearly recognizable in all 16 continent patients but only in 2 of 11 incontinent ones. The length of the bulb posterior to the sling was >10 mm (range, 10-28) in all continent patients and in 2 of the incontinent ones. The sling was coincident with a line drawn through the long axis of the pubic bone in 9 of 16 continent patients. A statistically significant association was found between MRI qualitative findings and continence status (P <.0001). CONCLUSION: On the basis of our MRI results, the position of the sling and, in particular, the length of the urethral bulb posterior to the sling seem to be correlated with continence and must be considered in case of treatment failure.

Recurrent pseudodiverticula of female urethra: five-year experience.

OBJECTIVES: To report our experience of transvaginal diverticulectomy with pubovaginal sling placement in a series of 32 women with recurrent urethral pseudodiverticula. METHODS: A total of 32 women underwent surgical repair from January 2000 to June 2007. Of the 32 women, 12 had undergone other concomitant previous urethral surgery, predominantly for stress urinary incontinence. Transvaginal excision of the diverticulum and concomitant pubovaginal sling placement were performed routinely. The women were evaluated postoperatively for symptom relief, anatomic result, and postoperative continence status at 1, 6, and 12 months and annually thereafter. Pelvic magnetic resonance imaging was repeated after 1 year. RESULTS: The mean follow-up was 4.3 years. In all cases, the voiding urethrogram after catheter removal showed a good urethral shape with an absence of urinary leaks. At the postoperative urodynamic investigation, 27 patients had an unobstructed and 5 an equivocal Blaivas-Groutz nomogram. Three patients (20%) reported a persistent degree of stress urinary incontinence, including 2 with grade 1 stress urinary incontinence and 1 with mixed incontinence. Two patients presented with clinically evident diverticulum recurrence, and in 1 patient, an intraurethral diverticulum, was found at the 1-year magnetic resonance imaging examination. CONCLUSIONS: A pubovaginal sling added routinely to all diverticulectomy procedures offers significant support to the urethral repair and/or prevention of urinary incontinence, including in recurrent cases, and does not increase the risk of erosion into the urethra or fistula formation.

Sacral neuromodulation enabling simultaneous pancreas and kidney transplantation: a first case.

We report a case where simultaneous pancreas and kidney transplantation was precluded because of recurrent urinary tract infections due to non-obstructive chronic urinary retention requiring clean intermittent self catheterisation in a diabetic woman with end stage renal disease. Sacral neuromodulation restored voiding and cured recurrent urinary tract infections, enabling her to undergo simultaneous pancreas and kidney transplantation.

Hyperbaric oxygen therapy in BKV-associated hemorrhagic cystitis refractory to intravenous and intravesical cidofovir: case report and review of literature.

Hemorrhagic cystitis is a common complication in hematopoietic stem cell transplant recipients. We report here a case of severe BKV-associated hemorrhagic cystitis who did not respond to intravenous cidofovir. Overt hematuria successfully resolved after a few days on hyperbaric oxygen and intravesical instillations of cidofovir, while BK viruria dropped after a few weeks and remained low. We review the literature for therapeutic options in hemorrhagic cystitis and try to explain how hyperbaric oxygen stimulates mucosal repair in the urinary bladder.

Cold-knife incision of anastomotic strictures after radical retropubic prostatectomy with bladder neck preservation: efficacy and impact on urinary continence status.

OBJECTIVES: To evaluate the incidence and characteristics of anastomotic strictures (AS) after radical retropubic prostatectomy (RRP) with bladder-neck preservation (BNP), the efficacy of management with cold-knife incision (CKI), and its impact on urinary continence. METHODS: Seven hundred five consecutive patients who underwent RRP with BNP were prospectively followed with uroflowmetry at postoperative months 1, 3, 6, 9, 12, and investigated for urinary incontinence with the 1-h pad test at AS diagnosis obtained with urethroscopy. If the instrument could not dilate the stricture, CKI was subsequently performed. Follow-up after treatment was performed with uroflowmetry and 1-h pad test at months 1, 3, 6, 9, 12. Recurrent AS was always treated with repeated CKI. RESULTS: Six hundred forty-eight patients were assessable. After a median time of 3.8 mo from RRP, 46 (7.1%) patients developed AS. Urinary incontinence was present in 21 (46%) men at AS diagnosis. Three (7%) patients were successfully managed by urethroscopic dilation only, whereas 43 (93%) required CKI. Eleven (26%) of the latter had recurrent AS. After a median follow-up of 48 mo from the last AS treatment, all patients are stricture-free, de novo urinary incontinence was never documented, and of the 21 originally incontinent men, 11 became continent, 8 improved and 2 remained unchanged. CONCLUSIONS: In our experience, BNP does not decrease the incidence of AS after RRP; however, AS can be effectively managed with repeated CKI with a final 100% success rate. CKI has a possible positive impact on urinary continence in 90% of patients, without causing de novo incontinence.

Contribution of early intensive prolonged pelvic floor exercises on urinary continence recovery after bladder neck-sparing radical prostatectomy: results of a prospective controlled randomized trial.

AIMS: In this prospective controlled randomized trial we assessed the effects of early, intensive, prolonged pelvic floor exercises (PFE) on urinary incontinence following bladder neck (BN) sparing RRP. METHODS: A sample of 152 patients with localized prostate cancer underwent RRP with BN preservation. Out of this group we randomized 107 incontinent patients into 2 groups. We considered incontinent patients with 24 hr Pad test >2 g. The T group received instructions regarding an intensive program of PFE, from 7 days after catheter removal for as long as any degree of incontinence persisted, within a period of 1 year. The control (C) group did not receive instructions. The outcome was assessed using the 24 hr Pad test, a visual analogue scale (VAS) and a single question of QoL. Results at baseline and at 1, 3, 6, and 12 months were available for 54 and 40 patients, respectively. RESULTS: The overall spontaneous continence rate after catheter removal was 23.6%. The proportion of men still incontinent was significantly higher in the C group than treatment (T) group at 1 (97.5% vs. 83.3%; P = 0.04), 3 (77.5% vs. 53.7%; P = 0.03), 6 (60% vs. 33.3%; P = 0.01), and 12 months (52.5% vs. 16.6%; P < 0.01). Similarly, the VAS and the response to the QoL question at 12 months significantly differed between the two groups (P = 0.01 and 0.03, respectively). CONCLUSIONS: Our study suggests that early intensive prolonged PFE can further increase the number of continent patients and this improvement persists in the first 12 months. The second 6 months following surgery are still useful to recovery.

Male bulbourethral sling after radical prostatectomy: intermediate outcomes at 2 to 4-year followup.

PURPOSE: We reviewed our experience with 49 consecutive patients undergoing a male sling procedure. MATERIALS AND METHODS: The 7-item International Prostate Symptom Score and 22-item incontinence quality of life questionnaire (although not validated in Italian) were used to assess the clinical impact of the bulbourethral sling. Surgical outcome was also assessed by videourodynamics at 1 year. Urodynamic success was defined as no leakage during videourodynamic evaluation. RESULTS: Mean followup was 32 months (range 26 to 48). Preoperatively 3 patients used 2 pads daily (mild incontinence), 34 used 3 to 5 (moderate incontinence) and the remaining 12 used more than 5 (severe incontinence). Clinical success was defined as a decrease in pad use to completely dry (no pad) or to social continence (1 pad daily) at followup. Of the 49 patients 38 (77%), 33 (67%) and 63% (31) were considered socially continent at the 3-month, 1-year and 3-year followup, respectively. Only 15 of the 49 patients (30%) were considered completely dry at the 3-year followup. Significant perineal pain was reported in the early postoperative period but it resolved in all patients. Infection occurred in 3 patients, while no erosion was found. CONCLUSIONS: The male perineal sling is a safe surgical option for post-prostatectomy urinary incontinence, especially when strict patient selection is done. Patient satisfaction is superior to urodynamic results and the procedure allows physiological voiding. Patients should be informed of the possibility of progressive failure with time and significant perineal pain in the early postoperative period.