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.

Sexuality and erectile function after implantation of an Adjustable Transobturator Male System (ATOMS) for urinary stress incontinence. A multi-institutional prospective study.

OBJECTIVES: To investigate erectile function and sexuality before/after implantation of the ATOMS device including continence outcome, pain perception and co-morbidities. MATERIALS AND METHODS: We collected data from 34 patients (2010-2014) who were provided with an ATOMS implant due to mild or moderate stress urinary incontinence (SUI) after radical prostatectomy (RPE), transurethral resection (TURP) or radiotherapy. Previous failed implants were no contraindication. Sexuality was evaluated with the International Index of Erectile Function (IIEF-5). The Visual Analog Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) were used to analyse pain perception. Results regarding continence, influence of co-morbidities and drug intake were interpreted. RESULTS: IIEF-5 score increased 6 months after ATOMS implantation with a mean difference of 2.18 (Cl: 1.22, 3.14), p < 0,001). Non-sexually active patients had the greatest benefit. However, 50% of patients achieved a mean IIEF-5 of 10.1 and 38% of patients reported a new onset of sexual activity at follow up (mean IIEF-5 score of 12.9). This is in accordance with reduced SUI and absence of persistent pain syndrome. Overall success rate regarding 24h pad-use was 88% (no pad rate 38%). Previous failed implants did not influence results but diabetes, obesity and drug intake (beta-blockers, antidepressants) led to poorer outcomes. CONCLUSION: Sexuality and erectile function improves significantly 6 months after ATOMS implantation. We postulate that reduced SUI (also during sexual activity) and absence of chronic pain are the improving factors. ATOMS should be offered to men with mild to moderate SUI who are interested in regaining their erectile function and sexual activity.

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.

Bladder outlet obstruction (BOO) in men with castration-resistant prostate cancer.

OBJECTIVE: To evaluate the frequency of bladder outlet obstruction (BOO) and detrusor overactivity (DO) in patients with castration-resistant prostate cancer (CRPC) and lower urinary tract symptoms (LUTS). PATIENTS AND METHODS: Our prospective urodynamics database was queried. Inclusion criteria were CRPC and an International Prostate Symptom Score (IPSS) ≥ 20. Exclusion criteria were previous local therapy to the prostate gland, known urethral stricture disease, and a neurological component of LUTS. Twenty-one patients were identified. Urodynamic findings were analysed and compared with those of a matched cohort of 42 patients with benign prostatic enlargement (BPE). RESULTS: The median age of patients in the CRPC group was 74 years, and the median prostate-specific antigen (PSA) level at the time of the urodynamic study was 90 ng/mL. According to the BOO index, three patients (14%) were obstructed, three were equivocally obstructed (14%) and 15 were unobstructed. DO was seen in 12 patients (57%). Compared with the BPE group, patients with CRPC had lower cystometric bladder capacities (P = 0.003), were less likely to have BOO (14 vs 43%, P = 0.009) and more likely to have DO (57 vs 29%, P = 0.028). CONCLUSIONS: This study generates the hypothesis that only a minority of CRPC patients with LUTS have BOO, and that more than half of patients have DO. LUTS in CRPC may therefore be seldom attributable to BOO, but are, at least in part, related to DO and reduced cystometric capacity. A urodynamic investigation may be necessary before palliative transurethral resection of the prostate to select appropriate candidates. Larger prospective studies are needed to confirm our findings.

Bladder outlet obstruction in men with acute urinary retention: an urodynamic study.

OBJECTIVE: To identify clinical predictors of bladder outlet obstruction (BOO) in men with the first episode of spontaneous acute urinary retention (AUR), in order to facilitate patient selection for early de-obstructive prostate surgery. METHODS: A multichannel urodynamic investigation was performed in 156 consecutive men ≥ 50 years five days following AUR. Clinical routine parameters were evaluated for their ability to predict BOO, which was defined as a BOO-index (BOOI) >40. Univariable and multivariable logistic regression models were fitted. A nomogram was constructed from significant variables of a reduced multivariable model. Discrimination and calibration of the nomogram were assessed. RESULTS: The mean age of the 156 men was 71.6 years, and the mean drained volume was 953 mL. Seventy-two men (46.2 %) had severe AUR-associated pain. On urodynamic evaluation, 79 (50.6 %) were obstructed (BOOI > 40). In multivariable regression analysis, age (p = 0.014) drained volume (p = 0.044) and pain intensity (p < 0.001) were independently associated with BOO. These variables formed the basis of the nomogram, which predicted BOO with a bootstrap-corrected accuracy of 78.2 %. The positive predictive value, sensitivity, and specificity of a 70 % nomogram cutoff was 83, 51, and 90 %, respectively. Decision-curve analysis demonstrated a net benefit with use of the nomogram. CONCLUSIONS: The routine clinical parameters age, drained volume, and pain intensity are independent predictors of BOO in men with AUR. According to our model, patients with a nomogram predicted BOO probability of >70 % might be candidates for early surgery. External validation of the nomogram is advocated.

Lower urinary tract symptoms and depression.

UNLABELLED: Study Type--Symptom prevalence (cohort) Level of Evidence 2b. What's known on the subject? and What does the study add? Depression plays an important role in pathogenesis of BPH. Our study shows that prostatic symptoms can be helpful in the screening for depression. OBJECTIVE: • To evaluate the relationship between lower urinary tract symptoms (LUTS) and depression in men through validated questionnaires. PATIENTS AND METHODS: • Healthy male workers (n = 673) were invited to a free health check-up. • Patients underwent a detailed medical examination. • All participants completed the International Prostate Symptom Score (IPSS) questionnaire and the Beck Depression Inventory (BDI). RESULTS: • Under multiple logistic regression analysis (adjusted for total testosterone and age), a significant effect of IPSS on BDI score was observed: mild depression (BDI score >9): odds ratio (OR) 1.092, 95% confidence interval (CI) 1.056-1.129; P < 0.001; moderate-to-severe depression (BDI score >19): OR 1.093, 95% CI 1.031-1.159; P = 0.003; and severe depression (BDI score >29): OR 1.176, 95% CI 1.048-1.320; P = 0.006. CONCLUSIONS: • In healthy men, LUTS are significantly associated with depression. • The treatment of LUTS is very important for the mental health of older men.

Sex hormone-binding globulin is an independent predictor of biochemical recurrence after radical prostatectomy.

PURPOSE: We studied the association of serum sex hormone levels with clinicopathological variables and biochemical recurrence in men with prostate cancer treated with radical prostatectomy. MATERIALS AND METHODS: We prospectively studied preoperative serum sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, and free and total testosterone in 372 patients undergoing radical prostatectomy. Biochemical recurrence was analyzed in 285 patients and defined as prostate specific antigen 0.2 ng/ml or higher at least 30 days after radical prostatectomy. Median followup was 43.6 months. RESULTS: Median sex hormone-binding globulin was 37.4 nmol/l, luteinizing hormone 4.1 mU/ml, follicle-stimulating hormone 5.9 mU/ml, and free and total testosterone 0.069 and 3.7 ng/ml, respectively. There was no significant association of sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone or total testosterone with T and N stage, and margin status. Luteinizing hormone, follicle-stimulating hormone, and free and total testosterone were not associated with biochemical recurrence. In contrast, for each 10 U increase in sex hormone-binding globulin the risk of biochemical recurrence increased by 12% (p = 0.045). On multivariable analysis sex hormone-binding globulin achieved independent predictor status after adjusting for standard clinicopathological variables. After stepwise regression a model containing T and N stage, Gleason score, margin status, prostate weight and sex hormone-binding globulin improved the accuracy of a base model by 1.3% (79.0% vs 77.7%). CONCLUSIONS: Preoperative serum sex hormone-binding globulin is independently associated with biochemical recurrence after radical prostatectomy and increases the predictive accuracy of a standard multivariable model. Routine assessment of sex hormone-binding globulin sex hormone-binding globulin may be a helpful adjunct to identify patients who need early adjuvant therapy.

The value of transurethral bladder biopsy after intravesical bacillus Calmette-Guérin instillation therapy for nonmuscle invasive bladder cancer: a retrospective, single center study and cumulative analysis of the literature.

PURPOSE: We evaluated the need of routine transurethral biopsies after an induction course of intravesical bacillus Calmette-Guérin for high grade nonmuscle invasive bladder cancer. MATERIALS AND METHODS: This retrospective study included 180 patients with high grade nonmuscle invasive bladder cancer who underwent a 6-week induction course of bacillus Calmette-Guérin. Cystoscopic findings, urinary cytology and pathological results of transurethral biopsy were evaluated. For cumulative meta-analysis we systematically reviewed studies indexed in MEDLINE®, EMBASE® and Web of Science®. The records of 740 patients from a total of 7 studies were finally analyzed. RESULTS: Biopsy was positive in 58 patients (32%). Cystoscopy appeared normal in 75 patients (42%) and showed only erythema in 51 (28%) and tumor in 54 (30%), of whom 6 (8%), 11 (22%) and 41 (76%), respectively, showed positive findings at biopsy. The positive predictive value of erythema was 15% with negative cytology and 56% with positive cytology. The positive predictive value of a tumor with negative and positive cytology was 63% and 89%, respectively. A combination of negative cytology and normal cystoscopy was associated with a negative biopsy in 94% of cases. A total of 970 bladder biopsies were taken, of which 137 (14%) were positive, including 20 of 125 erythematous lesions (16%), 73 of 107 tumors (68%) and 44 of 738 normal-appearing areas (6%). Cumulative analysis findings were comparable. CONCLUSIONS: Routine transurethral bladder biopsies after a bacillus Calmette-Guérin induction course are not necessary. An individually approach is recommended, tailored from cystoscopic findings and cytology.

Prospective randomized multicenter study comparing prostate cancer detection rates of end-fire and side-fire transrectal ultrasound probe configuration.

OBJECTIVE: To prospectively test the hypothesis that end-fire transrectal ultrasound prostate biopsy probes have greater cancer detection rates than side-fire probes. Retrospective studies have suggested that such probes might have greater cancer detection rates. METHODS: The present prospective randomized multicenter trial aimed to compare the prostate cancer detection rates of the end-fire versus side-fire probe configuration during transrectal ultrasound-guided 12-core prostate biopsy. Patients were randomized according to age, prostate-specific antigen level and prostate volume. An interim analysis was planned after the inclusion of 300 patients. RESULTS: At the interim analysis after the inclusion of 297 patients, no differences were found in the mean prostate-specific antigen level (P = .412), mean age (P = .519), mean prostate volume (P = .730), and positive digital rectal examination findings (P = .295). The prostate cancer detection rate did not differ between the end-fire and side-fire probe (34.3% vs 34.4%, P = .972). On multivariate analysis, suspicious digital rectal examination findings (relative risk 8.185, P < .001), prostate-specific antigen level (relative risk 1.051, P = .041), and prostate volume (relative risk 0.973, P < .001), but not probe configuration (relative risk 0.942, P = .831), were independent predictive factors for the detection of prostate cancer. The interim analysis committee suggested that, because no difference of 5 absolute percent was achieved after 300 patients, no additional recruitment was necessary. Therefore, the study was terminated early. CONCLUSION: The results of the present study have shown that the transrectal ultrasound probe configuration does not affect the prostate cancer detection rate during transrectal ultrasound-guided prostate biopsy.