- Email: [email protected]
990 A NEW QUADRATIC SLING FOR MALE STRESS INCONTINENCE - RETROGRADE LEAK POINT PRESSURE AS A MEASURE OF URETHRAL RESISTANCE
Materials & Methods: Management of SUI associated with intrinsic sphincter deficiency (ISD) can be challenging after prior failed therapies. The Uromedica Adjustable Continence Therapy (ACT®) system is a device consisting of two silicone balloons providing urethral coaptation and bladder neck support. Each balloon is attached to a titanium port buried in the labia allowing for post-operative titration. The study population involves females with recurrent SUI with or without urethral hypermobility. Baseline and follow-up tests were performed at 6 weeks, 3 months, 6 months, 9 months, 12 months and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test (PPWT), direct visual stress test, Stamey score and validated questionnaires to assess the degree of stress incontinence, voiding dysfunction, sexual function and quality of life (IQol questionnaire). Results: Between 2002 and 2007, 162 patients were implanted (mean age 67.4 (31-94) years), with 142, 90, 75 and 45 patients completing at least 1, 2, 3 and 4 years follow-up respectively. The majority, 83% (N=135) had at least one or 2 (46%) previous anti-incontinence procedures.. Difficulty of surgery was rated as mild, moderate, or severe in 62%, 30%, and 9% of procedures respectively. Improvement in Stamey score of > 1 grade was achieved in 75.4% (107/142) at 1 year, in 75.6% (68/90) at 2 years, in 84.9% (62/73) at 3 years and in 92.9% (39/42) at 4 years. Dry rate (PPWT < 2 gms) was 51%, 62% and 74%, and 77% and > 50% improved rate was 80%, 86%, 83% and 89% at 1, 2, 3 and 4 years, respectively. IQoL increased from36.8 (SD 23.1) at baseline compared to 70.0 (SD 25.5), 71.7, 74.1 and 80.6 at 1, 2, 3 and 4 years. Optimal continence was achieved with a mean of 3 adjustments. Mean balloon volumes were 3.9 ml (1.0 – 11.5 ml). Device or procedure related complications (bladder perforation, port or balloon erosion, balloon migration, port or balloon related discomfort, intermittent urinary retention) were reported in 25% (39/156) of subjects at the end of 12 months, 19% (22/116) through year 2, 11.1% (10/90) through year 3 and 13.2% (3/22) through year 4. Of these, the majority were considered to be mild in severity. At 4 years 29 patients had undergone permanent explants of both devices, 43 were lost to follow up and 6 had died of unrelated causes. Conclusions: Four year data suggest ACT can be an effective, simple, safe and minimally invasive treatment for recurrent female SUI.
988
Randomized crossover study evaluating impact on quality of life and patient preference of urinary sheaths versus diapers in incontinent men
Chartier-Kastler E.1, Ballanger P.2, Petit J.3, Fourmarier M.4, Bart S.1, RagniGhazarossian E.5, Ruffion A.6, Le Normand L.7, Costa P.8 1 Medical School Pierre et Marie Curie, Paris VI, Dept. of Urology, Paris, France, 2 CHU, Hospital Pellegrin, Dept. of Urology, Bordeaux, France, 3Hospital Sud, Dept. of Urology, Amiens, France, 4Centre Hospitalier du Pays D'Aix, Dept. of Urology, Aix en Provence, France, 5Hospital Nord, Dept. of Urology, Marseille, France, 6Hospital Lyon Sud, Dept. of Urology, Lyon, France, 7CHU Nantes, Dept. of Urology, Nantes, France, 8CHU Caremeau, Dept. of Urology, Nîmes, France Introduction & Objectives: To evaluate the impact of urisheaths versus absorbent products (APs) on QoL in incontinent men. Materials & Methods: A randomised, controlled, crossover trial in 61 outpatient adult men with stable, moderate/heavy urinary incontinence was conducted from June 2007 to February 2009 in 14 urology centres. Participants tested Conveen Optima urisheaths and their usual AP for 2 wk each in random order. Impact on QoL was measured with the King’s Health Questionnaire (KHQ) and the SF-12 Acute questionnaire. Patient’s preference was recorded. A 10-item patient questionnaire was used to assess the product main advantages on an 11-point scale (0: worst; 10: best). A 72-h leakage diary was used to record the number and severity of leaks and daily product consumption. Safety was measured as the number of local adverse events. Results: All dimensions of the KHQ were scored lower with urisheaths, indicating an improvement in QoL, especially for “limitations of daily activities” (−10.24 ± 3.99, p = 0.01) and “impact of incontinence” (−7.05 ± 3.45, p < 0.05). The majority (69%) of patients preferred urisheaths to their usual AP (p = 0.002). Urisheaths scored significantly higher for all parameters (efficacy, self-image, odour management, discretion, skin integrity) other than ease of use. Safety was considered to be good Conclusions: Urisheaths showed a positive impact on QoL (according to the KHQ results) in moderate/heavily incontinent men, long-term users of APs. Participants largely preferred urisheaths. In view of these results, urisheaths may be recommended in preference to APs in incontinent men.
989
Multicenter experience with the self anchoring adjustable transobturator male system (ATOMS®) in the treatment of stress urinary incontinence in men; short term results in 99 patients
Primus G.1, Hoda R.2, Von Heyden B.3, Kühn M.4, Schmid N.5, Moll V.6, Hamza A.7, Karsch J.8, Brössner C.9, Fornara P.2, Bauer W.A.9 1 University Medical School Graz, Dept. of Urology, Graz, Austria, 2University Medical School Halle, Dept. of Urology and Kidney Transplantation, Halle, Germany, 3Clinic Plattenwald, Dept. of Urology, Bad Friedrichshall, Germany,
Eur Urol Suppl 2011;10(2):308
Johanniter Hospital Stendal, Dept. of Urology, Stendal, Germany, 5Clinic WelsGrieskirchen, Dept. of Urology, Wels, Austria, 6Diako - Die Stadtklinik, Uro Aktiv - Die Urologen Im Diako Das Ärztehaus, Augsburg, Germany, 7St. Georg Hospital, Dept. of Urology, Leipzig, Germany, 8Loretto Hospital, Dept. of Urology, Freiburg, Germany, 9Hospital Göttlicher Heiland, Dept. of Urology, Vienna, Austria 4
Introduction & Objectives: To report the first multicenter experience with a new designed self-anchoring adjustable transobturator male system (ATOMS®) for treatment of male stress urinary incontinence. Materials & Methods: From May 2009 to July 2010, 99 men with stress urinary incontinence were treated with the ATOMS® device. The most common indication was SUI after radical prostatectomy (92,9%). Failure of previous surgeries or devices was present in 34,3% patients (multiple failures in 17,17%, erosions of other implants 5,05%) and 31,3% patients were after secondary radiation. All patients received the implant with an outside-in technique by passing the obturator foramen and anchoring the device to the inferior pubic ramus. The titanium port was placed on the left symphysis region subcutaneously. Adjustments were performed via port access intraoperatively and after 3-4 weeks postoperatively if necessary. Pre- and postoperative evaluation consisted of assessment of incontinence symptoms, 24h-pad test, and 24h-pad count at 3 month, 6 month and 12 month after surgery. Results: All patients with average age of 70,6 years (55-87y) received the implant without intraoperative complications. 100% of the patients have more than 3 months follow up, 61,6% more than 6 months follow up and 25,3% more than 12 months follow up. The mean surgery time was 47 minutes (n=86, 29–112). After removal of transurethral catheter, temporary urinary retention occurred in 2 patients (2%). Transient perineal/scrotal dysaesthesia or pain was reported by 68 patients (68,6%) postoperatively and resolved spontaneously after using nonopioid analgesics. 6 (6,6%) Patients reported pain longer than 3 months. There were 4 (4,04%) cases of wound infection at the site of the titanium port leading to complete (2 patients) or only port (2 patient) explantation. In 1 (1,01%) patient an urethral erosion occurred after 8 month. After intraoperative adjustments with 4-8 mL, 31 (31,3%) patients were dry. In remaining 68 patients (68,6%) further adjustments were necessary. Mean number of adjustments during the follow-up was 3,8 (1-6). In total, at a mean follow-up time of 10.5 months (3-18), the overall success rate was 92%. At the same time, the mean pad use decreased significantly from 6,4 pads/d (2–12) to 1,13 pads/d (0 to 4 pads/d; p<0.001). Overall, 62 Patients (62,6%) were considered dry, 29 Patients (29,2%) were improved, and 8 patients (8,08%) were considered as failed. Conclusions: The ATOMS® System represents a safe and efficient implant for the treatment of male stress incontinence. Despite the integrated learning curve, the results are comparable with those achieved with other adjustable systems. In our opinion, the option of minimal invasive postoperative adjustment has firmly established its place in the spectrum of modern surgical treatment for incontinence.
990
A new quadratic sling for male stress incontinence – retrograde leak point pressure as a measure of urethral resistance
Comiter C.V.1, Nitti V.2, Rhee E.3 1 Stanford Medical School, Dept. of Urology, Stanford, United States of America, 2 New York University, Dept. of Urology, New York, United States of America, 3 Kaiser Permanente, Dept. of Urology, San Diego, United States of America Introduction & Objectives: Objective methods of assessing stress urinary incontinence (SUI) are essential for proper evaluation of post-prostatectomy incontinence (PPI) and for measuring the response to therapy. While symptom score and pad weight may be the most useful methods to evaluate pre-operative versus post-operative SUI status, neither can be used for intra-operative guidance regarding proper sling tensioning. The VIRTUE® quadratic sling is a new device for treating PPI that consists of a large pore knitted monofilament polypropylene mesh with two pre-attached inferior (trans-obturator, TO) extensions and two superior (pre-pubic, PP) extensions. We examine the resistance of the sling to leakage via measurement of retrograde leak point pressure (RLPP) during the key intraoperative fixation steps. Materials & Methods: As part of the evaluation of a new surgical technique for treating PPI, 16 consecutive men who elected VIRTUE sling surgery were evaluated with RLPP prior to surgery, and at critical stages of sling fixation during surgery. RLPP was measured via perfusion sphincterometry. With a 12F Foley catheter in the penile urethra, and the balloon inflated with 1 cc water, a 1-liter saline bag was connected to the catheter via cystoscopy tubing. The RLPP was recorded in centimeters water as the height of the fluid column above the symphysis at which fluid flow commences. RLPP was measured: 1) at baseline (sling extensions are passed, but no tensioning performed); 2) after the TO arms were tensioned and secured; 3) after the PP arms were tensioned (assistant pulling PP arms); and 4) after PP arms were secured in final position. Results: Mean age in the cohort was 70 yrs. Mean baseline RLPP was 36.4 ± 9.1 cm water. After TO fixation, mean RLPP increased to 45.9 ± 7.0 cm water. After PP tensioning, mean RLPP was 59.9 ± 12.1, and final RLPP after PP fixation increased to 68.4 ± 6.4 cm water. Each mean RLPP value for the cohort was statistically significantly higher than the preceding value. Conclusions: The VIRTUE sling provides urethral compression against the perineal membrane using a straightforward PP approach, and ventral elevation
of the bulbous urethra using a TO approach. The four extensions allow for a long segment of urethral compression while avoiding the risks associated with bone screws and retropubic needle passage. Both the TO and PP components of the quadratic fixation contributed to increasing urethral resistance, as measured by intra-operative RLPP. The quadratic fixation technique appears to have a potentially greater ability to provide urethral compression than does a purely prepubic or trans-obturator sling.
991
Two year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence
Rehder P.1, Pichler R.1, Schachtner L.1, Kerschbaumer A.1, Glodny B.2 1 Medical University Innsbruck, Dept. of Urology, Innsbruck, Austria, 2Medical University Innsbruck, Dept. of Radiology, Innsbruck, Austria Introduction & Objectives: To assess the efficacy and safety and of the transobturator retroluminal repositioning sling suspension in the treatment of male stress urinary incontinence (SUI) after prostate surgery with a follow-up of at least two years. The theory is that this sling supports residual sphincter function by optimization of membranous urethral support. Materials & Methods: In 112 patients with SUI after prostatic surgery a transobturator retroluminal repositioning sling suspension was implanted. Fourteen patients were lost to follow-up or had incomplete data. Patients (n=98) were evaluated including: 24-hour pad test, a questionnaire (ICIQ-SF), urodynamic evaluation and endoscopy, including “dynamic” urethroscopy and cystoscopy. Out of 98 patients, 95 had retropubic radical prostatectomies and three were incontinent after transurethral resection of the prostate. Nineteen patients had other previous therapies: 11 received bulking agents, eight had external beam radiotherapy, one had periurethral balloon placemements, one had a compressive sling which was removed. Results: At the two year follow-up 62% of the patients were cured, 21% were improved, and 16% were treatment failures. A significant difference was found between pre- and two year postoperative number of used pads and ICIQ-SF scores (p<0.05). No significant differences between pre- and postoperative postvoid residual urine volume and maximal flow rates were seen. In contrast to early postoperative complications like transient acute urinary retention or perineal pain no further complications occurred. Conclusions: The male transobturator retroluminal repositioning sling suspension is effective and safe in a follow-up period of two years. Long term results remain stable, except in the subgroup of patients that received adjuvant radiotherapy. The extent of preoperative evaluation and examination is much more considerable than when deciding to use a compressive type of treatment. This means that the transobturator retroluminal repositioning sling is successful in the long term, when enough residual sphincter function is left to benefit from dorsal support to the distal membranous urethra.
992
One hundred FlowSecure artificial urinary sphincters
Alonso Rodriguez D., Fes Ascanio E., Fernandez Barranco L., Vicens Vicens A., Garcia-Montes F. University Hospital Son Dureta, Dept. of Urology, Palma de Mallorca, Spain Introduction & Objectives: The FlowSecure artificial sphincter (AUS) with conditional occlusion was designed to address the problems reported with the currently gold standard AUS, the AMS-800. We report the outcome of this novel prosthesis on 100 patients over a mean follow up period of 21.7 months. Materials & Methods: 100 patients with stress urinary incontinence (SUI) of various aetiologies underwent bulbar urethra (96) or bladder neck (4) implantation of a FlowSecure AUS. All patient had tried conservative methods, 59 patients had undergone unsuccessful procedures for SUI (suburethral mesh, bulking agents, Proact and AMS-800) and 9 patients had undergone previous pelvic radiotherapy. At implantation, the device was left at atmospheric pressure in all cases. Patients attended for initial pressurisation 2-4 weeks after surgery and they were recalled at two week periods for a repeat pressurisation procedure when required. Pressurisation was conducted by injecting normal saline trough the self sealing port of the prosthesis in order to increase or decrease system pressure depending on individual clinical needs. Results: The procedure took an average of 38-47 minutes. Mean inpatient stay was 4.3 days. 53 patients had postoperative self-limited scrotal haematoma. Initial pressurisation required a mean volume of 3.7 ml. Further pressurisation was needed in 97 patients requiring a mean additional volume of 4.3 ml. Overall, 3 pressurisations procedures were required for recognition of socially satisfactory continence in 89 patients. Implants had to be removed in 28 patients due to early infection (8), late infection secondary to pressurisation (5), perforation of the pump at pressurisation (9) and mechanical failure (6). Conclusions: The FlowSecure AUS is an easily implantable prosthesis which allows for adjustability when needed. Though it has been designed for bulbar urethra, the implant can also be placed around the bladder neck. Satisfactory continence rates can be achieved operating at a lower pressure than the AMS-800. We have identified a high risk for system infection and pump puncturing during the
pressurisation procedure. A revision of the mechanical system has been performed and the pump has been redesigned to prevent punctures in the future.
Poster Session 83 OUTCOMES FOLLOWING OPEN VERSUS LAPAROSCOPIC/ROBOTIC PROSTATECTOMY Monday, 21 March, 14.00-15.30, Hall E2
993
A meta-analysis comparing complication and positive surgical margin rates of 110,016 patients undergoing open retropubic, laparoscopic, and robotic-assisted radical prostatectomy
Sooriakumaran P.1, Bloch D.2, Kreaden-Seshadri U.3, Hebert A.E.3, Wiklund P.4, Tewari A.K.1 1 Weill Cornell Medical College, Dept. of Urology, New York, United States of America, 2Stanford University School of Medicine, Dept. of Statistics, Stanford, United States of America, 3Intuitive Surgical, Inc., Dept. of Statistics, Sunnyvale, United States of America, 4Karolinska Institute, Dept. of Urology, Stockholm, Sweden Introduction & Objectives: There is no clear evidence to support one form of surgical approach over another with regards radical prostatectomy. The aim of this study was to analyze the literature available between 2002 and 2008 and compare positive surgical margin and complication rates for open retropubic, laparoscopic, and robotic radical prostatectomy. Materials & Methods: A total of 110,016 patients formed the basis of this metaanalysis, representing the largest compilation of radical prostatectomy patients in the literature. Summary data were abstracted on year of publication, preoperative patient characteristics, positive surgical margins, estimated blood loss, blood transfusions, conversions, length of hospital stay, and total intra- and perioperative complications, with a further 21 individual perioperative complications selected a priori for abstraction and analysis. Results: The open and laparoscopic surgical groups had similar overall positive surgical margin rates, with the robotic group having lower rates. Both minimally invasive approaches showed significantly lower estimated blood loss and rate of blood transfusions, and a shorter length of hospital stay when compared to an open approach. A further decrease in these parameters was seen when robotic assistance was used. Total complication rates were highest for the open approach, intermediate for the laparoscopic cohort, and lowest for the robotic group. For the individual complication analysis, the rates for death, readmission, reoperation, ureteral, bladder, and rectal injury, ileus, pneumonia, fistula, and wound infection showed significant differences between groups. Conclusions: Robotic assisted laparoscopic radical prostatectomy has overall lower perioperative morbidity and improved early oncologic outcomes compared to conventional laparoscopic or open approaches. Further studies comparing longer term oncologic and functional outcomes, as well as cost-benefit comparisons are needed before making recommendations for or against a specific type of surgery.
994
Prospective non-randomized comparison of surgical invasiveness of extraperitoneal laparoscopic and open retropubic radical prostatectomy
Hoda M.R., Greco F., Wagner S., Fischer K., Kawan F., Fornara P. Martin-Luther University Halle/Wittenberg, Dept. of Urology and Kidney Transplantation Center, Halle, Germany Introduction & Objectives: Major surgical procedures cause often a systemic stress response with subsequent changes in hemodynamics and organ perfusion. Laparoscopic surgery has been proposed to result in less induced surgical trauma and a diminished stress response. Perioperative release of inflammatory markers, cytokines and adipocytokines in patients undergoing laparoscopic and open radical prostatectomy was examined. Materials & Methods: A total of 580 patients were enrolled in this prospective, non-randomized study. Blood samples were collected preoperatively, and up to 5 day postoperatively. Serum concentrations of acute phase markers (CRP and SAA), interleukins (IL-6, IL-10) and adipocytokine leptin were measured at each time-point by means of ELISA. Clinical data were collected by reviewing patients records. Laparoscopic extraperitoneal radical prostatectomy (LRP) was performed in 286 patients (group I), open retropubic radical prostatectomy (RRP) in 294 patients (group II). Results: LRP resulted in less bleeding (p<0.05), faster recovery (p<0.05) and less duration of catheterization (p<0.05). There were no significant differences in the oncological outcome of patients treated by RRP or LRP in our series. Patients undergoing LRP had significantly lower IL-6 and adipocytokine levels at all measurement time-points. However, a biphasic kinetics of adipocytokine serum levels has been observed during the postoperative course in all patients.
Eur Urol Suppl 2011;10(2):309
988
Randomized crossover study evaluating impact on quality of life and patient preference of urinary sheaths versus diapers in incontinent men
Chartier-Kastler E.1, Ballanger P.2, Petit J.3, Fourmarier M.4, Bart S.1, RagniGhazarossian E.5, Ruffion A.6, Le Normand L.7, Costa P.8 1 Medical School Pierre et Marie Curie, Paris VI, Dept. of Urology, Paris, France, 2 CHU, Hospital Pellegrin, Dept. of Urology, Bordeaux, France, 3Hospital Sud, Dept. of Urology, Amiens, France, 4Centre Hospitalier du Pays D'Aix, Dept. of Urology, Aix en Provence, France, 5Hospital Nord, Dept. of Urology, Marseille, France, 6Hospital Lyon Sud, Dept. of Urology, Lyon, France, 7CHU Nantes, Dept. of Urology, Nantes, France, 8CHU Caremeau, Dept. of Urology, Nîmes, France Introduction & Objectives: To evaluate the impact of urisheaths versus absorbent products (APs) on QoL in incontinent men. Materials & Methods: A randomised, controlled, crossover trial in 61 outpatient adult men with stable, moderate/heavy urinary incontinence was conducted from June 2007 to February 2009 in 14 urology centres. Participants tested Conveen Optima urisheaths and their usual AP for 2 wk each in random order. Impact on QoL was measured with the King’s Health Questionnaire (KHQ) and the SF-12 Acute questionnaire. Patient’s preference was recorded. A 10-item patient questionnaire was used to assess the product main advantages on an 11-point scale (0: worst; 10: best). A 72-h leakage diary was used to record the number and severity of leaks and daily product consumption. Safety was measured as the number of local adverse events. Results: All dimensions of the KHQ were scored lower with urisheaths, indicating an improvement in QoL, especially for “limitations of daily activities” (−10.24 ± 3.99, p = 0.01) and “impact of incontinence” (−7.05 ± 3.45, p < 0.05). The majority (69%) of patients preferred urisheaths to their usual AP (p = 0.002). Urisheaths scored significantly higher for all parameters (efficacy, self-image, odour management, discretion, skin integrity) other than ease of use. Safety was considered to be good Conclusions: Urisheaths showed a positive impact on QoL (according to the KHQ results) in moderate/heavily incontinent men, long-term users of APs. Participants largely preferred urisheaths. In view of these results, urisheaths may be recommended in preference to APs in incontinent men.
989
Multicenter experience with the self anchoring adjustable transobturator male system (ATOMS®) in the treatment of stress urinary incontinence in men; short term results in 99 patients
Primus G.1, Hoda R.2, Von Heyden B.3, Kühn M.4, Schmid N.5, Moll V.6, Hamza A.7, Karsch J.8, Brössner C.9, Fornara P.2, Bauer W.A.9 1 University Medical School Graz, Dept. of Urology, Graz, Austria, 2University Medical School Halle, Dept. of Urology and Kidney Transplantation, Halle, Germany, 3Clinic Plattenwald, Dept. of Urology, Bad Friedrichshall, Germany,
Eur Urol Suppl 2011;10(2):308
Johanniter Hospital Stendal, Dept. of Urology, Stendal, Germany, 5Clinic WelsGrieskirchen, Dept. of Urology, Wels, Austria, 6Diako - Die Stadtklinik, Uro Aktiv - Die Urologen Im Diako Das Ärztehaus, Augsburg, Germany, 7St. Georg Hospital, Dept. of Urology, Leipzig, Germany, 8Loretto Hospital, Dept. of Urology, Freiburg, Germany, 9Hospital Göttlicher Heiland, Dept. of Urology, Vienna, Austria 4
Introduction & Objectives: To report the first multicenter experience with a new designed self-anchoring adjustable transobturator male system (ATOMS®) for treatment of male stress urinary incontinence. Materials & Methods: From May 2009 to July 2010, 99 men with stress urinary incontinence were treated with the ATOMS® device. The most common indication was SUI after radical prostatectomy (92,9%). Failure of previous surgeries or devices was present in 34,3% patients (multiple failures in 17,17%, erosions of other implants 5,05%) and 31,3% patients were after secondary radiation. All patients received the implant with an outside-in technique by passing the obturator foramen and anchoring the device to the inferior pubic ramus. The titanium port was placed on the left symphysis region subcutaneously. Adjustments were performed via port access intraoperatively and after 3-4 weeks postoperatively if necessary. Pre- and postoperative evaluation consisted of assessment of incontinence symptoms, 24h-pad test, and 24h-pad count at 3 month, 6 month and 12 month after surgery. Results: All patients with average age of 70,6 years (55-87y) received the implant without intraoperative complications. 100% of the patients have more than 3 months follow up, 61,6% more than 6 months follow up and 25,3% more than 12 months follow up. The mean surgery time was 47 minutes (n=86, 29–112). After removal of transurethral catheter, temporary urinary retention occurred in 2 patients (2%). Transient perineal/scrotal dysaesthesia or pain was reported by 68 patients (68,6%) postoperatively and resolved spontaneously after using nonopioid analgesics. 6 (6,6%) Patients reported pain longer than 3 months. There were 4 (4,04%) cases of wound infection at the site of the titanium port leading to complete (2 patients) or only port (2 patient) explantation. In 1 (1,01%) patient an urethral erosion occurred after 8 month. After intraoperative adjustments with 4-8 mL, 31 (31,3%) patients were dry. In remaining 68 patients (68,6%) further adjustments were necessary. Mean number of adjustments during the follow-up was 3,8 (1-6). In total, at a mean follow-up time of 10.5 months (3-18), the overall success rate was 92%. At the same time, the mean pad use decreased significantly from 6,4 pads/d (2–12) to 1,13 pads/d (0 to 4 pads/d; p<0.001). Overall, 62 Patients (62,6%) were considered dry, 29 Patients (29,2%) were improved, and 8 patients (8,08%) were considered as failed. Conclusions: The ATOMS® System represents a safe and efficient implant for the treatment of male stress incontinence. Despite the integrated learning curve, the results are comparable with those achieved with other adjustable systems. In our opinion, the option of minimal invasive postoperative adjustment has firmly established its place in the spectrum of modern surgical treatment for incontinence.
990
A new quadratic sling for male stress incontinence – retrograde leak point pressure as a measure of urethral resistance
Comiter C.V.1, Nitti V.2, Rhee E.3 1 Stanford Medical School, Dept. of Urology, Stanford, United States of America, 2 New York University, Dept. of Urology, New York, United States of America, 3 Kaiser Permanente, Dept. of Urology, San Diego, United States of America Introduction & Objectives: Objective methods of assessing stress urinary incontinence (SUI) are essential for proper evaluation of post-prostatectomy incontinence (PPI) and for measuring the response to therapy. While symptom score and pad weight may be the most useful methods to evaluate pre-operative versus post-operative SUI status, neither can be used for intra-operative guidance regarding proper sling tensioning. The VIRTUE® quadratic sling is a new device for treating PPI that consists of a large pore knitted monofilament polypropylene mesh with two pre-attached inferior (trans-obturator, TO) extensions and two superior (pre-pubic, PP) extensions. We examine the resistance of the sling to leakage via measurement of retrograde leak point pressure (RLPP) during the key intraoperative fixation steps. Materials & Methods: As part of the evaluation of a new surgical technique for treating PPI, 16 consecutive men who elected VIRTUE sling surgery were evaluated with RLPP prior to surgery, and at critical stages of sling fixation during surgery. RLPP was measured via perfusion sphincterometry. With a 12F Foley catheter in the penile urethra, and the balloon inflated with 1 cc water, a 1-liter saline bag was connected to the catheter via cystoscopy tubing. The RLPP was recorded in centimeters water as the height of the fluid column above the symphysis at which fluid flow commences. RLPP was measured: 1) at baseline (sling extensions are passed, but no tensioning performed); 2) after the TO arms were tensioned and secured; 3) after the PP arms were tensioned (assistant pulling PP arms); and 4) after PP arms were secured in final position. Results: Mean age in the cohort was 70 yrs. Mean baseline RLPP was 36.4 ± 9.1 cm water. After TO fixation, mean RLPP increased to 45.9 ± 7.0 cm water. After PP tensioning, mean RLPP was 59.9 ± 12.1, and final RLPP after PP fixation increased to 68.4 ± 6.4 cm water. Each mean RLPP value for the cohort was statistically significantly higher than the preceding value. Conclusions: The VIRTUE sling provides urethral compression against the perineal membrane using a straightforward PP approach, and ventral elevation
of the bulbous urethra using a TO approach. The four extensions allow for a long segment of urethral compression while avoiding the risks associated with bone screws and retropubic needle passage. Both the TO and PP components of the quadratic fixation contributed to increasing urethral resistance, as measured by intra-operative RLPP. The quadratic fixation technique appears to have a potentially greater ability to provide urethral compression than does a purely prepubic or trans-obturator sling.
991
Two year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence
Rehder P.1, Pichler R.1, Schachtner L.1, Kerschbaumer A.1, Glodny B.2 1 Medical University Innsbruck, Dept. of Urology, Innsbruck, Austria, 2Medical University Innsbruck, Dept. of Radiology, Innsbruck, Austria Introduction & Objectives: To assess the efficacy and safety and of the transobturator retroluminal repositioning sling suspension in the treatment of male stress urinary incontinence (SUI) after prostate surgery with a follow-up of at least two years. The theory is that this sling supports residual sphincter function by optimization of membranous urethral support. Materials & Methods: In 112 patients with SUI after prostatic surgery a transobturator retroluminal repositioning sling suspension was implanted. Fourteen patients were lost to follow-up or had incomplete data. Patients (n=98) were evaluated including: 24-hour pad test, a questionnaire (ICIQ-SF), urodynamic evaluation and endoscopy, including “dynamic” urethroscopy and cystoscopy. Out of 98 patients, 95 had retropubic radical prostatectomies and three were incontinent after transurethral resection of the prostate. Nineteen patients had other previous therapies: 11 received bulking agents, eight had external beam radiotherapy, one had periurethral balloon placemements, one had a compressive sling which was removed. Results: At the two year follow-up 62% of the patients were cured, 21% were improved, and 16% were treatment failures. A significant difference was found between pre- and two year postoperative number of used pads and ICIQ-SF scores (p<0.05). No significant differences between pre- and postoperative postvoid residual urine volume and maximal flow rates were seen. In contrast to early postoperative complications like transient acute urinary retention or perineal pain no further complications occurred. Conclusions: The male transobturator retroluminal repositioning sling suspension is effective and safe in a follow-up period of two years. Long term results remain stable, except in the subgroup of patients that received adjuvant radiotherapy. The extent of preoperative evaluation and examination is much more considerable than when deciding to use a compressive type of treatment. This means that the transobturator retroluminal repositioning sling is successful in the long term, when enough residual sphincter function is left to benefit from dorsal support to the distal membranous urethra.
992
One hundred FlowSecure artificial urinary sphincters
Alonso Rodriguez D., Fes Ascanio E., Fernandez Barranco L., Vicens Vicens A., Garcia-Montes F. University Hospital Son Dureta, Dept. of Urology, Palma de Mallorca, Spain Introduction & Objectives: The FlowSecure artificial sphincter (AUS) with conditional occlusion was designed to address the problems reported with the currently gold standard AUS, the AMS-800. We report the outcome of this novel prosthesis on 100 patients over a mean follow up period of 21.7 months. Materials & Methods: 100 patients with stress urinary incontinence (SUI) of various aetiologies underwent bulbar urethra (96) or bladder neck (4) implantation of a FlowSecure AUS. All patient had tried conservative methods, 59 patients had undergone unsuccessful procedures for SUI (suburethral mesh, bulking agents, Proact and AMS-800) and 9 patients had undergone previous pelvic radiotherapy. At implantation, the device was left at atmospheric pressure in all cases. Patients attended for initial pressurisation 2-4 weeks after surgery and they were recalled at two week periods for a repeat pressurisation procedure when required. Pressurisation was conducted by injecting normal saline trough the self sealing port of the prosthesis in order to increase or decrease system pressure depending on individual clinical needs. Results: The procedure took an average of 38-47 minutes. Mean inpatient stay was 4.3 days. 53 patients had postoperative self-limited scrotal haematoma. Initial pressurisation required a mean volume of 3.7 ml. Further pressurisation was needed in 97 patients requiring a mean additional volume of 4.3 ml. Overall, 3 pressurisations procedures were required for recognition of socially satisfactory continence in 89 patients. Implants had to be removed in 28 patients due to early infection (8), late infection secondary to pressurisation (5), perforation of the pump at pressurisation (9) and mechanical failure (6). Conclusions: The FlowSecure AUS is an easily implantable prosthesis which allows for adjustability when needed. Though it has been designed for bulbar urethra, the implant can also be placed around the bladder neck. Satisfactory continence rates can be achieved operating at a lower pressure than the AMS-800. We have identified a high risk for system infection and pump puncturing during the
pressurisation procedure. A revision of the mechanical system has been performed and the pump has been redesigned to prevent punctures in the future.
Poster Session 83 OUTCOMES FOLLOWING OPEN VERSUS LAPAROSCOPIC/ROBOTIC PROSTATECTOMY Monday, 21 March, 14.00-15.30, Hall E2
993
A meta-analysis comparing complication and positive surgical margin rates of 110,016 patients undergoing open retropubic, laparoscopic, and robotic-assisted radical prostatectomy
Sooriakumaran P.1, Bloch D.2, Kreaden-Seshadri U.3, Hebert A.E.3, Wiklund P.4, Tewari A.K.1 1 Weill Cornell Medical College, Dept. of Urology, New York, United States of America, 2Stanford University School of Medicine, Dept. of Statistics, Stanford, United States of America, 3Intuitive Surgical, Inc., Dept. of Statistics, Sunnyvale, United States of America, 4Karolinska Institute, Dept. of Urology, Stockholm, Sweden Introduction & Objectives: There is no clear evidence to support one form of surgical approach over another with regards radical prostatectomy. The aim of this study was to analyze the literature available between 2002 and 2008 and compare positive surgical margin and complication rates for open retropubic, laparoscopic, and robotic radical prostatectomy. Materials & Methods: A total of 110,016 patients formed the basis of this metaanalysis, representing the largest compilation of radical prostatectomy patients in the literature. Summary data were abstracted on year of publication, preoperative patient characteristics, positive surgical margins, estimated blood loss, blood transfusions, conversions, length of hospital stay, and total intra- and perioperative complications, with a further 21 individual perioperative complications selected a priori for abstraction and analysis. Results: The open and laparoscopic surgical groups had similar overall positive surgical margin rates, with the robotic group having lower rates. Both minimally invasive approaches showed significantly lower estimated blood loss and rate of blood transfusions, and a shorter length of hospital stay when compared to an open approach. A further decrease in these parameters was seen when robotic assistance was used. Total complication rates were highest for the open approach, intermediate for the laparoscopic cohort, and lowest for the robotic group. For the individual complication analysis, the rates for death, readmission, reoperation, ureteral, bladder, and rectal injury, ileus, pneumonia, fistula, and wound infection showed significant differences between groups. Conclusions: Robotic assisted laparoscopic radical prostatectomy has overall lower perioperative morbidity and improved early oncologic outcomes compared to conventional laparoscopic or open approaches. Further studies comparing longer term oncologic and functional outcomes, as well as cost-benefit comparisons are needed before making recommendations for or against a specific type of surgery.
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Prospective non-randomized comparison of surgical invasiveness of extraperitoneal laparoscopic and open retropubic radical prostatectomy
Hoda M.R., Greco F., Wagner S., Fischer K., Kawan F., Fornara P. Martin-Luther University Halle/Wittenberg, Dept. of Urology and Kidney Transplantation Center, Halle, Germany Introduction & Objectives: Major surgical procedures cause often a systemic stress response with subsequent changes in hemodynamics and organ perfusion. Laparoscopic surgery has been proposed to result in less induced surgical trauma and a diminished stress response. Perioperative release of inflammatory markers, cytokines and adipocytokines in patients undergoing laparoscopic and open radical prostatectomy was examined. Materials & Methods: A total of 580 patients were enrolled in this prospective, non-randomized study. Blood samples were collected preoperatively, and up to 5 day postoperatively. Serum concentrations of acute phase markers (CRP and SAA), interleukins (IL-6, IL-10) and adipocytokine leptin were measured at each time-point by means of ELISA. Clinical data were collected by reviewing patients records. Laparoscopic extraperitoneal radical prostatectomy (LRP) was performed in 286 patients (group I), open retropubic radical prostatectomy (RRP) in 294 patients (group II). Results: LRP resulted in less bleeding (p<0.05), faster recovery (p<0.05) and less duration of catheterization (p<0.05). There were no significant differences in the oncological outcome of patients treated by RRP or LRP in our series. Patients undergoing LRP had significantly lower IL-6 and adipocytokine levels at all measurement time-points. However, a biphasic kinetics of adipocytokine serum levels has been observed during the postoperative course in all patients.
Eur Urol Suppl 2011;10(2):309