Age at surgery is not a prognostic factor for the AdVance-XP male sling efficacy: A post-hoc analysis of a prospective 7-year multicentric study.

OBJECTIVE: To evaluate the factor age at the surgery on long-term postoperative outcomes in patients with postprostatectomy incontinence (PPI) after AdVance XP transobturator male sling implantation. METHODS: A total of 115 male patients with PPI, who had undergone AdVance XP sling implantation, were included. Patients had PPI with endoscopically confirmed good sphincteric-contractility and a positive coaptive response. Kruskal-Wallis test with Dunn post-hoc tests were used to analyze the postoperative outcome differences between the patient groups aged less than 66, 66-75, and over greater than 75 years. Outcome measures were the 24 h pad test, the number of daily pads used, the International Consultation on Incontinence Questionnaire short form (ICIQ-SF), International Quality of Life Score (IQOL), Patient Global Impression of Improvement (PGI-I), International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), and Visual Analog Scale scores. Observation time points were 3, 6, 12, 24, 36, 48, 60, and 84 months after surgery. RESULTS: Between the age groups, there was no difference in the success rate of the procedure (defined as 0 pads/24 h and less than 5 g in the 24-h pad test) at any point in time. Subjective parameters measures using the ICIQ-SF, PGI-I, IQOL, and IPSS scores showed no differences between the two cohorts. Only erectile function (IIEF-5 score) was lower in older patients in comparison to the cohort aged less than 66 years (p < 0.05 at 3, 6, 12, 24, 36, and 48 months). CONCLUSIONS: The present study complements the European multicentre AdVance XP follow-up study. Here, we show that age at surgery does not affect the objective success, subjective success, or the complication rate. Thus, we do not recommend factoring in chronological age into surgical selection criteria for the AdVance XP implantation.

Five-Year Results of a Prospective Multicenter Trial: AdVance XP for Postprostatectomy-Incontinence in Patients with Favorable Prognostic Factors.

OBJECTIVE: The aim of this study was to assess the security, value, and efficacy of the second-generation AdVance male sling XP (Boston Scientific®), after implementation in 2010 with advantageous modifications in the sling structure and needle shape, in a prospective multicenter long-term follow-up study. METHODS: In total, 115 patients were included. Exclusion criteria were earlier incontinence (UI) surgery, nocturnal UI, former radiotherapy, or night-time incontinence. We also excluded patients with a functional urethra <1 cm in a preoperatively performed repositioning test. A consistent 24-h pad test, International Quality of Life (IQOL) score, visual analog pain scale (VAS), International Consultation-Incontinence Questionnaire (ICIQ-UI SF), International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), and Patient Global Impression of Improvement (PGI-I) scores were requested postoperatively. RESULTS: The 24-month follow-up (114 patients) revealed 64.0% cured and 28.8% improved patients. Mean urine loss was reduced significantly to 19.0 g (p < 0.001). A mean PGI score of 1.5 and a mean VAS score of 0.2 were obtained. The 60-month follow-up (59 patients) revealed 57.6% cured and 25.4% improved patients. Mean urine loss was reduced significantly to 18.3 g (p < 0.001). A mean PGI score of 1.6 and a mean VAS score of 0.2 were obtained. CONCLUSIONS: The AdVance XP displays excellent continence results and secure effectiveness over a 5-year period. Moreover, these data are demonstrating low complication rates and improved quality of life in the long-term use of AdVance XP.

Extended follow-up of the AdVance XP male sling in the treatment of male urinary stress incontinence after 48 months: Results of a prospective and multicenter study.

OBJECTIVE: To evaluate the efficacy and safety of the AdVance XP male sling in a midterm follow-up for the treatment of male urinary incontinence in a selected patient cohort. MATERIALS AND METHODS: In all, 115 patients with postprostatectomy incontinence were prospectively enrolled. A previous endoscopic evaluation of a sufficient coaptive zone in the repositioning test was mandatory. Patients with urine leakage in supine position or previous incontinence surgery were excluded. Postoperatively a standardized 24-hour pad test and pad usage were evaluated. To compare pre- and postoperative continence status nonparametric t test was used. A P-value of <.05 was seen as statistically significant. RESULTS: Median preoperative urine loss in the 24-hour pad test was 272 g (min. 42-max. 1600) and was significantly improved at any point in follow-up. Success was defined as 0 pads per day and a maximum of 5 g in the 24-hour pad test. After a follow-up of 48 months, 71.7% of the patients were cured, whereas 15.0% of patients had an improved continence situation and 13.3% were classified as failed. Mean urine loss decreased significantly to 24.4 g (P ≤ .001). No severe intra- or postoperative complications are to be reported. Median follow-up was 4.2 years. CONCLUSIONS: A stable effectiveness in a selected patient cohort can also be demonstrated in an extended follow-up. The complication rates are low and no late postoperative complications occurred, indicating the safety of the procedure.

36-month data for the AdVance XP® male sling: results of a prospective multicentre study.

OBJECTIVES: To evaluate the efficacy and safety of the AdVance XP® sling (Boston Scientific, formerly American Medical Systems) in male stress urinary incontinence (SUI) after radical prostatectomy in a prospective multicentre study, as in recent years several studies have shown the effectiveness and safety of the AdVance sling for treating male SUI and in 2010 the second-generation AdVance XP was introduced with several changes in the sling design and a new needle shape. PATIENTS AND METHODS: In all, 115 patients were included. Patients with nocturnal UI, previous UI surgery, previous radiotherapy and a coaptive zone of <1 cm in the preoperative repositioning test were excluded. Postoperatively, a standardised 24-h pad test, quality-of-life scores [International Quality of Life score (IQOL) and International Consultation on Incontinence Questionnaire short form (ICIQ-UI SF)], visual analogue scale (VAS) for pain, five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS) and Patient Global Impression of Improvement (PGI-I) score, were performed. All patients with a 0-5 g pad test were defined as cured and improved with a reduction of urine loss of >50%. All others were classified as failures. Significance analysis was performed using the Wilcoxon test. RESULTS: The mean (median) preoperative urine loss in the 24-h pad test was 272.0 (272.0) g. After a follow-up of 3 months (114 patients), 64.9% of the patients were cured and 31.6% had an improved continence status. The mean urine loss decreased significantly to 34.9 g (P < 0.001), with a mean VAS score of 0.5, and mean PGI-I of 1.5. After a follow-up of 24 months (80 patients), 68.8% of the patients were cured and 22.5% had improved. The mean urine loss decreased significantly to 19.1 g (P < 0.001), with a mean VAS score of 0.3, and mean PGI-I of 1.5. After a follow-up of 36 months (47 patients), 66.0% of the patients were cured and 23.4% had improved. The mean urine loss decreased significantly to 21.8 g (P < 0.001), with a mean VAS score of 0.0, and mean PGI-I of 1.6. The mean IQOL and ICIQ-UI SF improved significantly (both P < 0.001) after 36 months. There were no significant postoperative changes in IIEF-5 and IPSS. No intraoperative and no long-term complications occurred. No erosion or explanations occurred. CONCLUSION: The AdVance XP shows good and stable effectiveness and low complication rates even at a mid-term follow-up of up to 36 months.

AdVanceXP male sling: 2-year results of a multicentre study.

PURPOSE: For the treatment of persistent post-prostatectomy incontinence (PPI), several surgical treatment options including male slings are available. In 2010, the second generation of the retrourethral male sling Advance, AdVanceXP, was introduced. Aim of the study was to examine in a prospective multicentre study the outcome of AdVanceXP in the treatment of PPI. METHODS: Ninety-four patients were treated with AdVanceXP. Patients with nocturnal incontinence, previous incontinence surgery, with coaptive zone <1 cm and irradiated patients were excluded. Measurements included: daily pad usage, 24-h pad weight test, post-operative pain in the visual analogue scale, International Quality of Life questionnaire, International Consultation on Incontinence Questionnaire short form, IEEF5 and Patient Global Impression of Improvement. Adverse events were recorded. All patients with no pads and 0-5 g in the 24-h pad test were defined as cured and those with a reduction in urine loss >50 % as improved. RESULTS: Preoperatively, the median 24-h pad weight test was 274 g and daily pad usage was 3. At 1-year follow-up, 66.3 % of patients could be classified as cured and 25.3 % as improved. After 2 years, 73.1 % could be classified as cured and 19.6 % as improved. Urine loss decreased (p < 0.001), and quality of life improved significantly (p < 0.001). Mean PGI was 1.5 after 1 year and 1.4 after 2 years. Majority of complications were minor. No intraoperative complications and five serious post-operative events occurred (grade IIIB complications). No explantation was necessary. CONCLUSIONS: AdVanceXP, when correctly indicated, shows good effectiveness and low complication rates after up to 2 years.