Patient reported outcomes of intermittent self-dilatation after direct vision internal urethrotomy.

PURPOSE: Long-term results on quality of life (QoL) as well as clinical outcomes of intermittent self-dilatation (ISD) of the urethra after direct visual internal urethrotomy (DVIU) are scarce. The aim of this study was to prospectively evaluate patient reported outcomes (PROs) on voiding symptoms and QoL in a large cohort of urethral stricture patients performing ISD. METHODS: We identified a total of 121 patients who performed ISD following DVIU between 2008 and 2013. Baseline assessment was conducted for each patient before ISD was started. Follow-up visits were scheduled in 6-month intervals. Each assessment included the following questionnaires: International prostate symptom score (IPSS), IPSS quality of life index (IPSS-QoL), patient global impression of severity (PGI-S), and patient global impression of improvement (PGI-I). Additional parameters were maximum urinary flow rate (Qmax ), postvoid residual urine, rate of complications, and stricture recurrence. Linear mixed models were used to examine the change over the course of the follow-up visits to the baseline. RESULTS: The median age of the patients was 58 years (interquartile range [IQR]: 43-70). The median follow-up was 17 months (IQR: 7-30). Mean change from baseline IPSS was -6.1, -5.9, -4.2, and -4.8 points at 6, 24, 36, and 48 months. Mean change from baseline IPSS-QoL was -1.3, -1.4, -1.6, and -1.8 points, respectively. Mean PGI-I was 1.7 points at 6, 1.9 points at 24, 1.9 points at 36, and 2.2 points at 48 months after ISD initiation. Mean change of Qmax ranged from 1.7 at 6 to 2.2 mL/s at 48 months. The median complication rate was 3.3% per 6-month ISD interval. Overall, 11 patients developed stricture recurrence (9%). CONCLUSION: ISD after DVIU had no negative impact on patients' QoL (IPSS-QoL, PGI-I, PGI-S). Urodynamic parameters remained stable for up to 48 months with low complications and an acceptable stricture recurrence rate.

Long-Term Results after Suprapubic ARC Procedure for the Treatment of Stress Urinary Incontinence in Women: A Retrospective Data Analysis.

INTRODUCTION: The aim of this study was to evaluate long-term safety and efficacy of the suprapubic arc (SPARC) procedure for the surgical treatment of stress urinary incontinence (SUI). MATERIALS AND METHODS: 139 female patients treated by SPARC were included in this retrospective analysis, whereby 126 patients were available for follow-up after 1 year, 70 after 6 years, and 41 after 9 years. The cough test, pad test, uroflowmetry, and post-void residual volume measurements were performed. Severity of bother (visual analogous scale [VAS] 0-10), continence, and the satisfaction rate were assessed. Objective cure was defined as a negative cough test and pad weight ≤1 g, subjective cure as no urine loss during daily activities and no usage of pads. The VAS, pad weight, number of pads per day, and maximal flow rate were compared preoperatively and postoperatively. RESULTS: Objective cure rates at 1, 6, and 9 years were 78.6, 71.4, and 70.7% and subjective cure rates were 72.2, 55.7, and 65.8%, respectively. The VAS, pad weight, number of pads, and maximal flow rate decreased significantly. Study limitations include a relatively small sample size and the retrospective fashion of the analysis. CONCLUSIONS: In the long-term context, SPARC showed to represent an efficient and safe procedure for treatment of female SUI.

Adjustable Continence Balloons in Men: Adjustments Do Not Translate Into Long-term Continence.

OBJECTIVE: To evaluate the functional results, morbidity, and quality of life of the adjustable continence balloons ProACT for the treatment of male stress urinary incontinence after prostate surgery considering both short- and long-term results. METHODS: Between 2002 and 2012, twenty-two consecutive male patients were implanted with the ProACT device. Continence was defined by the use of 0 pads daily, and the quality of life was assessed by validated questionnaires. RESULTS: Only 1 patient (4.5%) was immediately continent after ProACT implantation, and the other 21 men (95.5%) needed ≥1 balloon refillments postoperatively. The baseline daily pad number decreased from a mean of 5.9 pads (range, 3-12 pads) to a mean of 1.7 pads (range, 0-5 pads) per day after refilling but increased to a mean of 3.9 (range, 0-10) at the last follow-up visit. After balloon adjustments, 4 patients (18%) were continent and 18 patients (82%) showed an improvement with a 95% rate of subjective satisfaction. Revision and explantation rates were 73% and 55%, respectively. At a median follow-up of 57 months, only 1 patient (4.5%) remained dry, and only 10 patients (45%) remained satisfied with the procedure, whereas 12 patients (55%) were unchanged and dissatisfied. CONCLUSION: The ProACT device appears to be safe and efficacious in the short term. The postoperative readjustment allows the achievement of a short-term continence status. However, on the long term, the ProACT does not appear to be an ideal device for durable continence and patients' satisfaction.

Sexual function in women with stress urinary incontinence treated with the SPARC sling system.

AIM: To evaluate the impact of SPARC on female sexual function. METHODS: 151 women with a mean age of 60 ± 11.90 and SUI had a complete urodynamic investigation and underwent SPARC operation. 98 women completed the validated female sexual function index questionnaire (FSFI) at baseline and 94 women at follow-up. A minimum follow-up of 12 months was required for study inclusion. RESULTS: 52/98 women were sexually active at baseline. Postoperatively only 33 patients were sexually active. The FSFI score of all 33 pre- and postoperative sexually active women increased from 25.3 ± 5.7 at baseline to 27.4 ± 4.8 at follow-up (P = 0.1). Scores of women with reduced sexual function at baseline increased significantly in the domains desire, arousal, and lubrication as well as orgasm and satisfaction and total FSFI-score (P = 0.002) postoperatively. CONCLUSIONS: Our results suggest that the SPARC-sling procedure for SUI did not negatively interfere with female sexual function.

Clinical impact of body mass index on the outcome of the SPARC-sling system for the treatment of female stress urinary incontinence.

PURPOSE: Of this observational study was to evaluate the clinical outcome of the suprapubic arc (SPARC)-sling system in women with stress urinary incontinence according to body mass index (BMI). MATERIALS AND METHODS: A total of 151 women underwent SPARC between June 2001 and March 2009 at a single tertiary academic center. A complete urodynamic investigation was performed preoperatively. A minimum follow-up of 12 months was required, which left data of 93 individuals for analyses. Participants were divided into the following: A, non-obese (BMI 18.5 to <25 kg/m(2)), B, overweight (BMI 25 to <30 kg/m(2)), and C, obese (BMI 30-35 kg/m(2)). Objective and subjective cure rates, as well as overall success rate and self-perceived severity of bother, were measured. Moreover, participants were asked about their satisfaction after surgery. RESULTS: Median follow-up was 7.6 years. Mean number of pads/day, pad test, and self-perceived severity of bother were significantly reduced overall, as well as in each BMI category (P < 0.001). In multivariable analyses, BMI was not an independent predictor of objective cure rate, coded either as continuous (P = 0.108) or as categorical variable (P for trend 0.301). Similarly, BMI was not an independent predictor of subjective cure rate, both coded as continuous (P = 0.475) and as categorical variable (P for trend 0.690). Overall, 92% (A), 85% (B), and 80% (C) of participants were satisfied with the surgical outcome at follow-up, respectively. CONCLUSIONS: BMI failed to achieve independent predictor status regarding objective and subjective cure rate at follow-up. A high BMI is not a contraindication to SPARC, more studies are recommended to confirm these findings.

Early results of a European multicentre experience with a new self-anchoring adjustable transobturator system for treatment of stress urinary incontinence in men.

OBJECTIVE: To report our experience with a new self-anchoring adjustable transobturator male system (ATOMS®; AMI, Vienna, Austria) for the treatment of stress urinary incontinence (SUI) in men. PATIENTS AND METHODS: A total of 99 men, in a number of centres, were treated for SUI with the new ATOMS® device. The device was implanted in all patients using an outside-in technique by passing the obturator foramen and anchoring the device to the inferior pubic ramus. The titanium port was placed s.c. on the left symphysis region. Adjustments were performed via port access. Postoperative evaluation consisted of physical examination, 24-h pad test, and 24 h-pad count. Preoperatively and at 6-month follow-up, patients completed a validated quality-of-life questionnaire. Two-way ANOVA was used to analyse changes over time. Within-group effects for time were tested using post hoc Dunnett's contrasts of baseline values vs subsequent measurements. RESULTS: The most common indication was SUI after radical prostatectomy (92.9%). Failure of previous surgeries was present in 34.3% patients and 31.3% patients had undergone secondary radiation. The mean (SD; range) surgery time was 47 (13.8; 29-112) min. Temporary urinary retention occurred in two patients (2%) and transient perineal/scrotal dysaesthesia or pain was reported by 68 patients (68.7%) and resolved after 3-4 weeks of non-opioid analgesics. There were four (4%) cases of wound infection at the site of the titanium port leading to explantation. No urethral or bladder injuries related to the device or erosions occurred. The mean (SD; range) number of adjustments to reach the desired result (dryness, improvement and/or patient satisfaction) was 3.8 (1.3; 1-6). After a mean (SD; range) follow-up time of 17.8 (1.6; 12-33) months, the overall success rate was 92% and the mean pad use decreased from 7.1 to 1.3 pads/24 h (P < 0.001). Overall, 63% were considered dry and 29% were improved. CONCLUSION: Treatment of male SUI with this self-anchored adjustable system is safe and effective.

Premature preoperative discontinuation of antiplatelet drug therapy in cardiovascular risk patients: a preliminary study on the role of P2Y12 receptor monitoring.

BACKGROUND AND OBJECTIVE: In high-bleeding risk procedures, discontinuation of antiplatelet drug therapy with clopidogrel may be requested by surgeons, usually 7-10 days before the surgical procedure. New platelet function tests, such as the vasodilator-stimulated phosphoprotein phosphorylation assay, may help to assess the perioperative status of the clopidogrel-specific P2Y12 receptor. METHODS: Using vasodilator-stimulated phosphoprotein phosphorylation assay, the platelet reactivity index (PRI) was measured in 80 individuals, including 20 healthy volunteers, 20 cardiologic patients under full antiplatelet drug therapy with clopidogrel and aspirin, 20 surgical patients without any antiplatelet drugs and 20 patients under clopidogrel, discontinued 7 days before the surgical procedure. RESULTS: The mean PRI (95% confidence interval) in healthy volunteers was 86 (82-89%) and that in the surgical control group was 77% (72-81%). In cardiologic patients under full antiplatelet therapy, mean PRI was 51% (42-60%). In the clopidogrel discontinuation group, PRI increased from 51% (40-62%) on day 0 to 65% (57-74%) on day 3 and to 76% (69-84%) on day 5. On the morning of surgery, mean PRI was 85% (80-91%). The PRI values on the 5th day were equivalent to those of the surgical control group (mean difference -0.4%, 95% confidence interval -8.6% to 7.8%, P = 0.9). Fifty-five percent of the patients in the discontinuation group had a PRI of more than 50% on day 0. CONCLUSION: The study using vasodilator-stimulated phosphoprotein phosphorylation assay, one of the new platelet function assays for the assessment of inhibition of platelet P2Y12 receptor, demonstrates that the PRI on day 5 after discontinuation of clopidogrel is equivalent to a surgical control group and it questions the rigid practice of delaying surgery for 7-10 days, particularly in patients without a clopidogrel effect.

SPARC sling system for treatment of female stress urinary incontinence in the elderly.

OBJECTIVE: To investigate the safety and efficacy of the suprapubic arch (SPARC) sling procedure for the management of stress urinary incontinence (SUI) in elderly women. METHOD: Forty-three women, aged 65-91 yr, underwent the SPARC procedure for urodynamic SUI. Before surgery, a complete medical history was obtained and a urogynecology examination and urodynamic test were performed. The objective cure rate was evaluated by clinical and urodynamic examination at 3, 6, and 12 mo and the subjective cure rate was assessed using a visual analogue score and a global patient impression questionnaire. RESULTS: No severe intraoperative or postoperative complications occurred. No patient referred de novo urge incontinence. Significant differences were found between the preoperative and postoperative number of daytime voidings (p < 0.001), the pad weights and numbers of pads used (p < 0.001), and the visual analogue score (p = 0.021). No significant differences in preoperative and postoperative urodynamic parameters were reported. At the mean follow-up of 36+/-14 mo (range, 12-54 mo), objective and subjective cure rates were 91% and 95%, respectively. CONCLUSIONS: The SPARC procedure is effective and offers a satisfactory cure rate without significant morbidity in elderly women with SUI.

Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy.

OBJECTIVES: We assessed the incidence of morbidity and bother on quality-of-life (QL) after radical retropubic prostatectomy for prostate cancer. METHODS: At least 12 months after surgery, self-reporting questionnaires were completed and returned by 368 (77.8%) of 473 eligible patients. Surgery related morbidity was evaluated by adhoc constructed questions. QL was assessed by the European Organization for Research and Treatment of Cancer QL core questionnaire (EORTC QLQ-C30). Multivariate and univariate analysis as well as regression analysis were used to assess the bother factors. RESULTS: Postoperative urinary incontinence significant enough for the patient to use some kind of protection was reported by 27.2%. After surgery, 14.2% of preoperative potent men were able to get and maintain an erection sufficient enough for sexual intercourse without any aid. Overall 10.6% of respondents had undergone surgery for anastomotic stricture and 23.6% reported on adjuvant therapy. Furthermore, 43.2% reported on fear of not being cured from cancer. Postoperative urinary incontinence and fear of not being cured were associated with significant lower global QL scores and turned out as independent predictors for global QL. In contrast, postoperative erectile dysfunction, anastomotic stricture and adjuvant therapy were not independent predictors. In addition, 82.1% would vote for surgery again. CONCLUSION: The majority of the patients would opt for surgical treatment again, although morbidity is common after radical prostatectomy and may impair QL. Particularly urinary incontinence and fear of not being cured are independent predictors for global QL after surgery. Therefore, surgical techniques with a low morbidity are requested as well as some kind of psychological support in order to cope with existential fear.