Complications of the urinary incontinence system ATOMS: description of risk factors and how to prevent these pitfalls.

BACKGROUND: We report on our multicentre evaluation of the occurrence and management of complications with the ATOMS device (A.M.I., Austria). PATIENTS AND METHODS: Between 10/09 and 09/18, a total of 187 patients with persistent postoperative stress urinary incontinence received an ATOMS device in Madrid (n = 101) or Halle (n = 86). This prospective evaluation was carried out consecutively. In addition to complications, patient age, BMI, comorbidities and previous treatments for prostate cancer and urinary incontinence were examined. Statistical analysis was performed with GraphPad Prism 7® (GraphPad Software, Inc., La Jolla, USA); p < 0.05 was considered significant. RESULTS: The average age of the overall population was 69.4 years, with a mean CCI of 4.3. In total, 18.2% of the patients had diabetes mellitus, 21.9% were irradiated, and 14.1% and 22.9% underwent previous surgery for urinary incontinence and urethral stricture, respectively. The overall success rate of the device was 80.2%. A total of 51 postoperative complications (51/187, 27.3%) were observed, with 18 grade I (9.6%), 1 grade II (0.5%), 3 grade IIIa (1.6%) and 29 grade IIIb (15.5%) complications. The most serious postoperative complications were primary wound infection (8/187, 4.3%) and long-term cutaneous erosion with subsequent infection (15/187, 8.02%). The main risk factors for complications were previous radiotherapy (p = 0.003) and surgery for urethral stricture (p = 0.017). No other parameters were significant in bivariate analysis (p > 0.05). CONCLUSION: The most severe complications of ATOMS implantation were primary wound infection and cutaneous erosion, especially in the presence of previous radiotherapy. Particular focus on performing hygienic and accurate implantation techniques is recommended.

An overview of the ATOMS generations: port types, functionality and risk factors.

BACKGROUND: We report the multicentre comparison of the different port types of the adjustable transobturator male incontinence system (ATOMS, A.M.I., Austria). METHODS: Between 10/09 and 10/16, 383 patients received an ATOMS. Of these, 63% received the inguinal port (IP, 2009-2013), 23% the intraoperative manually connectable scrotal port (SP, 2013-2015), and 14% the pre-connected fully silicone-covered scrotal port (SSP, 2014-2016). During the follow-up period, continence parameters, pain and quality of life ratings and postoperative port-associated complications were evaluated and compared. Statistical analysis was performed with GraphPad Prism 7®, p < 0.05 considered as significant. RESULTS: Regarding preoperative parameters (BMI, ASA score, previous radiotherapy/incontinence surgery, and preoperative 24-h pad count/24-h pad test), no significant differences were found. Regarding perioperative parameters, the mean operative time was significantly shorter for the SP and SSP (IP vs. SP p < 0.0001, IP vs. SSP p = 0.0048, SP vs. SSP p = 0.697). Comparison of the postoperative 24-h pad count, 24-h pad test and uroflowmetry data revealed no significant differences. However, the postoperative ICIQ-SF score was significantly better for the SSP (p = 0.0232) than the SP. A significant difference was also observed in postoperative port-associated complications. According to the Clavien-Dindo classification, we identified one grade I and 29 grade IIIb complications for the IP, 1 grade I and 6 grade IIIb complications for the SP, but only 2 grade IIIb complications for the SSP (IP vs. SP p = 0.0231, IP vs. SSP p = 0.0189 and SP vs. SSP p = 0.0453). CONCLUSION: The SSP shows fewer complications while retaining comparable efficacy.

Significance of Hyperbaric Oxygenation in the Treatment of Fournier's Gangrene: A Comparative Study.

INTRODUCTION: Hyperbaric oxygenation (HBO), in addition to anti-infective and surgical therapy, seems to be a key treatment point for Fournier's gangrene. The aim of this study was to investigate the influence of HBO therapy on the outcome and prognosis of Fournier's gangrene. PATIENTS AND METHODS: In the present multicenter, retrospective observational study, we evaluated the data of approximately 62 patients diagnosed with Fournier's gangrene between 2007 and 2017. For comparison, 2 groups were distinguished: patients without HBO therapy (group A, n = 45) and patients with HBO therapy (group B, n = 17). The analysis included sex, age, comorbidities, clinical symptoms, laboratory and microbiological data, debridement frequency, wound dressing, antibiotic use, outcome and prognosis. The statistical analysis was performed with GraphPad Prism 7® (GraphPad Software, Inc., La Jolla, USA). RESULTS: Demographic data showed no significant differences. The laboratory parameters C-reactive protein and urea were significantly higher in group B (group B: 301.7 vs. 140.6 mg/dL; group A: 124.8 vs. 54.7 mg/dL). Sepsis criteria were fulfilled in 77.8 and 100% of the patients in groups A and B respectively. Treatment in the intensive care unit (ICU) was therefore indicated in 69% of the patients in group A and 100% of the patients in group B. The mean ICU stay was 9 and 32 days for patients in groups A and B respectively. The wound debridement frequency and hospitalization stay were significantly greater in group B (13 vs. 5 debridement and 40 vs. 22 days). Initial antibiosis was test validated in 80% of the patients in group A and 76.5% of the patients in group B. Mortality was 0% in group B and 4.4% in the group A. CONCLUSION: The positive influence of HBO on the treatment of Fournier's gangrene can be estimated only from the available data. Despite poorer baseline findings with comparable risk factors, mortality was 0% in the HBO group. The analysis of a larger patient cohort is desirable to increase the significance of the results.

Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

OBJECTIVE: To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. PATIENTS AND METHODS: In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (<10 mL/day and 0-1 pad/day), device durability, treatment failure, and device complications were recorded. Nonparametric tests were used for statistical analyses. RESULTS: After a median (interquartile range [IQR]) follow-up of 31 (10-54) months and a median (IQR) of 3 (2-4) adjustments, the overall success rate was 90% (258 men) and the dry rate was 64% (184). Daily pad test and pad use decreased from a median of 400 mL/day and 4 pads/day to a median of 18 mL/day and 1 pad/day (both P < 0.001), concomitantly QoL ratings significantly improved and changed to a high level of satisfaction (PGI-I 4 to 2, ICIQ-SF 17 to 5; both P < 0.001). The UI results at 12 months were comparable to those at final follow-up. Chronic pain and intraoperative complications did not occur. Most of the postoperative complications were Clavien-Dindo grade I-III (no grade IV or V). At present, 231 (80%) of all the ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P < 0.001) were prognostic factors for beneficial treatment outcome. CONCLUSION: The ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy.

Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation.

BACKGROUND: We report on our 5-year experience with the adjustable transobturator male system (ATOMS®, A.M.I., Feldkirch, Austria). METHODS: Between 10-2009 and 10-2014, 54 patients received an ATOMS. The mean follow-up of this retrospective observational trial was 27.5 ± 18.4 (2.3-59) months. Within each follow-up, the following were evaluated: micturition protocol, 24-h pad count, uroflowmetry and residual volume. Statistical analysis was performed with SigmaPlot® 11.0, p < 0.05 considered as significant. RESULTS: Stress urinary incontinence (SUI) I°, II° and III° was seen in 1 (1.9 %), 16 (29.6 %) and 37 patients (68.5 %), respectively. In summary, 48.1 % of the patients became "dry" (0-"safty pad"/day), while 29.6 % achieved at least an "improvement" of about more than 50 % (1-2 pads/day), which corresponds to an overall success rate of 77.7 %. The mean number of pads/day decreased from 7.7 to 1.6. Regarding the initial degree of SUI, patients with mild or moderate incontinence had a significantly better outcome (p = 0.002, 95 % CI 0.9066 to 2.760). Postoperative complications were scaled according to the Clavien classification, in which we have seen 4 grade I-, 1 grade IIIa- and 9 grade IIIb-complications (overall 25.9 %). The evaluation of quality of life by ICIQ-SF showed a significant improvement (p = 0.0001, 95 % CI -14.56 to -11.75). CONCLUSION: The treatment of male SUI using the ATOMS incontinence system achieved the best results in patients with mild and moderate incontinence. For severe incontinent patients, the system represents an efficient alternative.

Performance and functional outcome of endoscopic extraperitoneal radical prostatectomy in relation to obesity: an assessment of 500 patients.

OBJECTIVE: To investigate the impact of obesity on the performance and functional outcome of endoscopic extraperitoneal radical prostatectomy (EERPE). PATIENTS AND METHODS: We retrospectively examined 500 patients treated with EERPE; they were categorized into three groups according to the World Health Organization classification of obesity: normal weight (body mass index, BMI, <25.0 kg/m(2)), overweight (25.0-29.9 kg/m(2)) and obese (30.0 kg/m(2)). The database of our institution was reviewed and perioperative data evaluated. The functional data were collected through questionnaires before and after EERPE and analysed statistically. RESULTS: The age, prostate size and preoperative PSA level were similar in all three groups. The mean (sd) BMI was 27 (3.3) kg/m(2), with 26.8%, 56.6% and 16.6% of the patients classed as normal, overweight and obese, respectively. A pelvic lymph node dissection and nerve-sparing was done in 218 and 123 patients, respectively. There was no statistically significance difference in the number of patients in each group who had previous procedures. Obese patients had a significantly higher American Society of Anesthesiologists score. The mean operative duration for all patients was 149 min; there was a statistically significant difference in duration among the three groups, with EERPE or nerve-sparing EERPE requiring a mean of 20 min more in obese patients. There was no conversion to open surgery. The estimated mean blood loss was 200 mL; four patients, none of them in the obese group, received a blood transfusion. At 3 months after EERPE there was a trend to worse continence in obese patients, but it was not statistically significant, and was not apparent at 6 months. There was no difference in transfusion rate and duration of catheterization. CONCLUSION: EERPE seems to be a feasible and reproducible surgical technique in obese patients, although the operation takes longer.

Quo Vadis Botulinum Toxin: Normative Constraints and Quality of Life for Patients With Idiopathic OAB?

Background: Idiopathic overactive bladder (iOAB), with or without urge incontinence (UI), has significant psychosocial effects on patients' quality of life (QoL). The first choice of treatment for iOAB is anticholinergics and, alternatively, the ß-3-adrenoceptor agonist mirabegron. However, systemic side effects and contraindications should be considered for both medications. Objective: We report the efficacy, safety and effects on QoL of botulinum toxin therapy (onabotulinum toxin type A, BOTOX®, Allergan) among patients with iOAB ± UI. Patients and Methods: Between 2005 and 2013, 51 patients were treated with onabotulinum toxin A (100 units). The inclusion criteria were the presence of confirmed iOAB ± UI with previous use of anticholinergic medication. Micturition frequency, pad count, postvoid residual volume and QoL were evaluated using two validated questionnaires [the Client Satisfaction Questionnaire-8 (CSQ-8) and the King's Health Questionnaire (KHQ)]. Statistical analysis was performed with SPSS 24.0 (p < 0.05). Results: After botulinum toxin injection, a significant improvement in iOAB ± UI symptoms was observed. The micturition frequency decreased from 10.4 ± 0.5 to 5.2 ± 0.4 micturitions per day (p = 0.026), and the pad count decreased from 3.6 ± 1.0 to 1.2 ± 0.3 pads per day (p = 0.033). Anticholinergics were not used during the administration of botulinum toxin therapy. Complications and postoperative need for intermittent self-catheterization (ISC) were not observed. Overall, 72 and 24% of patients reported being "satisfied" or "very satisfied" with the treatment. Additionally, 66% of patients would choose botulinum toxin again for the treatment of iOAB. Conclusion: Botulinum toxin therapy is an efficient, safe, and life-improving treatment for iOAB.

Desperate need for better management of Fournier's gangrene.

INTRODUCTION: To compare earlier and later patient groups with Fournier's gangrene, specifically with the incidence of rising antibiotic resistance rates in mind. Primary endpoints were to compare therapy, outcomes, and resistance rates. MATERIAL AND METHODS: A multicentric, retrospective, multi-national study was performed. Two groups with different time frames of treatment were defined: Group 1 (n = 50) and Group 2 (n = 104). Demographics and outcomes were analysed using Student-t test, chi-square test, or Fisher exact test. Survival data were estimated using the Kaplan Meier method and compared by Log rank testing. RESULTS: There were no significant demographic differences. Nor was there any significant difference in therapy or outcomes in the groups except for the duration of intensive care unit treatment, which lasted a mean 6.3 days in Group 1 and 11.5 days in Group 2 (p = 0.018). Survival time did not improve over the years (p = 0.268). We fortunately did not observe an increased rate of multi-resistant organisms (p = 1.000). This study's limitations are mainly due to its retrospective study design. CONCLUSIONS: Despite increasing antibiotic resistance rates worldwide, it was not apparent in our population. But the situation for these patients is alarming, since final outcome failed to improve over the last ten years despite more intensive critical-care therapy.

[Treatment of ureteropelvic junction obstruction in adult age]. / Therapie der ureteropelvinen Stenose im Erwachsenenalter.

Ureteropelvic stenosis, also known as ureteropelvic junction obstruction, is an obstruction in the region of the pyeloureteral junction resulting in a urinary discharge disorder of the renal pelvis, which requires treatment.Since the first description of pyeloplasty by Trendelenburg in 1886 and the successful establishment of open pyeloplasty by Anderson and Hynes in 1949, the treatment strategies for ureteropelvic junction obstruction have developed considerably, especially in the last two decades. Although open pyeloplasty is still considered to be the gold standard, this concept is supplemented by modern minimally-invasive techniques today. These include laparoscopic pyeloplasty, laparoscopic single-site pyeloplasty, robot-assisted pyeloplasty, robot-assisted single-site pyeloplasty, and endopyelotomy. This article provides an overview of the different treatment strategies for ureteropelvic junction obstruction as well as the complication management of pyeloplasty in adult age.

The Adjustable Transobturator Male System in Stress Urinary Incontinence After Transurethral Resection of the Prostate.

OBJECTIVE: To investigate the efficacy and safety of the Adjustable Transobturator Male System (ATOMS) in men with stress urinary incontinence after transurethral resection of the prostate (TURP). MATERIALS AND METHODS: From a large international prospectively administrated ATOMS register, we identified 49 patients with an ATOMS device as a result of persistent stress urinary incontinence after TURP. For evaluation, the men were divided into standard transurethral resection of the prostate (sTURP) and palliative transurethral resection of the prostate (pTURP) in radiated patients. Baseline and follow-up measurements included continence parameters, urodynamics, quality-of-life surveys (Patient Global Impression-Improvement and International Consultation on Incontinence Questionnaire-Short Form), and pain ratings. The dry rate (0-1 security pad/<10 mL urine loss), the success rate (overall improvement), removals, complications, and treatment failures were recorded. A P value of <.05 was considered statistically significant. RESULTS: After a median of 34 and 22 months' follow-up and 2-3 adjustments, the sTURP and pTURP cohorts had 58% and 50% dry rates and 90% and 87% success rates. Hence, no improvement was seen in 10% and 13%. The removal rate was higher in pTURP (50% vs 10%, P = .0171) and infection was the most common side effect (50%) observed. Neither intraoperative nor Clavien-Dindo 4 and 5 adverse events were recorded. In sTURP and pTURP, the median daily pad count and the pad test improved significantly (all P <.001), and quality-of-life parameters shifted to a high satisfaction level (P <.001 and P = .001). Urodynamics remained unchanged and postoperative pain was not an issue. CONCLUSION: The ATOMS device shows promising treatment outcomes in patients after TURP and a similar efficacy as in postprostatectomy incontinence. There is no difference in continence outcome between sTURP and pTURP; however, a higher removal rate was found after pTURP, which may be important for patient counseling.

Registry of implants for the reconstruction of pelvic floor in males and females: A feasibility case series.

INTRODUCTION: Most aspects of implant-assisted reconstruction of pelvic floor in males and females are under debate and the research is not standardized. Registries are supposed to shed light to the indications, surgical techniques and material properties and to establish a standardized evaluation. METHODS: A working group was formed to create an online platform for registration and outcome measurement of implant-assisted operations for pelvic organ prolapse (POP) and female and male stress urinary incontinence (SUI). 20 patients with modified mesh materials were evaluated over 23 months follow up in the registry to prove the feasibility of the registry. For validation a previously published modified "satisfaction, anatomy, continence, safety - S.(A.)C.S score" was used. RESULTS: A consensus was met on definitions and classifications of patient variables, surgical procedures and implants, as well as outcome parameters (efficacy, continence, satisfaction, complications). Different subgroup modules were formed in accordance with treated condition. The maximum score of cure was reached by 25-100% of patients depending on the indication. CONCLUSION: A prospective registry in accordance with IDEAL-D framework is justified for the evaluation and regulation of implants for pelvic floor reconstruction.

Risk Factors for Treatment Failure With the Adjustable Transobturator Male System Incontinence Device: Who Will Succeed, Who Will Fail? Results of a Multicenter Study.

OBJECTIVE: To identify risk factors for treatment failure of men with the adjustable transobturator male system (ATOMS) for treating stress urinary incontinence (SUI). PATIENTS AND METHODS: Sixty-two patients with SUI after prostate surgery were provided with an ATOMS. The self-defined criteria for treatment failure (implant removal [A], no improvement or ≥3 pads/24 hours [B], and no improvement or ≥150 mL urine loss/24 hours [C]) were compared to anamnestic, clinical, and time-specific parameters: age, Charlson comorbidity index (CCI), urine culture (UC), previous ineffective implants, body mass index, radiotherapy, renal function (serum creatinine), smoker status, urethral strictures, SUI severity, surgery time, time to and season at implantation, and port system application. RESULTS: After a median follow-up of 17.7 months, 9 ATOMS (15%) were removed due to infection (8) or dysfunction (1); 23% and 16% had treatment failure of criteria B and C. Dry rate/overall success rate was 61%/87%. Age alone was no risk factor but the CCI and a positive UC were univariate significant predictors of the criteria A, B, and C. Besides, previous devices and renal failure were significantly associated with implant removal (A) and SUI severity with criterion C. In multivariate analysis, previous devices (P = .0163), positive UC (P = .0190), and SUI severity (P = .0123) were the strongest predictors of A, B, and C, respectively. CONCLUSION: A poor CCI, preoperative positive UC, severe SUI, and previous implants lead to more treatment failure and removal. Age, body mass index, radiotherapy, urethral strictures, current smoking, time-specific parameters, seasonality, and port system application did not influence the outcome.