Development of a patient and institutional-based model for estimation of operative times for robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium.

OBJECTIVES: To design a methodology to predict operative times for robot-assisted radical cystectomy (RARC) based on variation in institutional, patient, and disease characteristics to help in operating room scheduling and quality control. PATIENTS AND METHODS: The model included preoperative variables and therefore can be used for prediction of surgical times: institutional volume, age, gender, body mass index, American Society of Anesthesiologists score, history of prior surgery and radiation, clinical stage, neoadjuvant chemotherapy, type, technique of diversion, and the extent of lymph node dissection. A conditional inference tree method was used to fit a binary decision tree predicting operative time. Permutation tests were performed to determine the variables having the strongest association with surgical time. The data were split at the value of this variable resulting in the largest difference in means for the surgical time across the split. This process was repeated recursively on the resultant data sets until the permutation tests showed no significant association with operative time. RESULTS: In all, 2 134 procedures were included. The variable most strongly associated with surgical time was type of diversion, with ileal conduits being 70 min shorter (P < 0.001). Amongst patients who received neobladders, the type of lymph node dissection was also strongly associated with surgical time. Amongst ileal conduit patients, institutional surgeon volume (>66 RARCs) was important, with those with a higher volume being 55 min shorter (P < 0.001). The regression tree output was in the form of box plots that show the median and ranges of surgical times according to the patient, disease, and institutional characteristics. CONCLUSION: We developed a method to estimate operative times for RARC based on patient, disease, and institutional metrics that can help operating room scheduling for RARC.

International Robotic Radical Cystectomy Consortium: A way forward.

Robot-assisted radical cystectomy (RARC) is an emerging operative alternative to open surgery for the management of invasive bladder cancer. Studies from single institutions provide limited data due to the small number of patients. In order to better understand the related outcomes, a world-wide consortium was established in 2006 of patients undergoing RARC, called the International Robotic Cystectomy Consortium (IRCC). Thus far, the IRCC has reported its findings on various areas of operative interest and continues to expand its capacity to include other operative modalities and transform it into the International Radical Cystectomy Consortium. This article summarizes the findings of the IRCC and highlights the future direction of the consortium.

Analysis of intracorporeal compared with extracorporeal urinary diversion after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium.

BACKGROUND: Intracorporeal urinary diversion (ICUD) has the potential benefits of a smaller incision, reduced pain, decreased bowel exposure, and reduced risk of fluid imbalance. OBJECTIVE: To compare the perioperative outcomes of patients undergoing extracorporeal urinary diversion (ECUD) and ICUD following robot-assisted radical cystectomy (RARC). DESIGN, SETTING, AND PARTICIPANTS: We reviewed the database of the International Robotic Cystectomy Consortium (IRCC) (18 international centers), with 935 patients who had undergone RARC and pelvic lymph node dissection (PLND) between 2003 and 2011. INTERVENTION: All patients within the IRCC underwent RARC and PLND as indicated. The urinary diversion was performed either intracorporeally or extracorporeally. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Demographic data, perioperative outcomes, and complications in patients undergoing ICUD or ECUD were compared. All patients had at least a 90-d follow-up. The Fisher exact test was used to summarize categorical variables and the Wilcoxon rank sum test or Kruskal-Wallis test for continuous variables. RESULTS AND LIMITATIONS: Of 935 patients who had RARC and PLND, 167 patients underwent ICUD (ileal conduit: 106; neobladder: 61), and 768 patients had an ECUD (ileal conduit: 570; neobladder: 198). Postoperative complications data were available for 817 patients, with a minimum follow-up of 90 d. There was no difference in age, gender, body mass index, American Society of Anesthesiologists grade, or rate of prior abdominal surgery between the groups. The operative time was equivalent (414 min), with the median hospital stay being marginally longer for the ICUD group (9 d vs 8 d, p=0.086). No difference in the reoperation rates at 30 d was noted between the groups. The 90-d complication rate was not significant between the two groups, but a trend favoring ICUD over ECUD was noted (41% vs 49%, p=0.05). Gastrointestinal complications were significantly lower in the ICUD group (p ≤ 0.001). Patients with ICUD were at a lower risk of experiencing a postoperative complication at 90 d (32%) (odds ratio: 0.68; 95% confidence interval, 0.50-0.94; p=0.02). Being a retrospective study was the main limitation. CONCLUSIONS: Robot-assisted ICUD can be accomplished safely, with comparable outcomes to open urinary diversion. In this cohort, patients undergoing ICUD had a relatively lower risk of complications.

Efficacy of robot-assisted radical cystectomy (RARC) in advanced bladder cancer: results from the International Radical Cystectomy Consortium (IRCC).

OBJECTIVE: To characterise the surgical feasibility and outcomes of robot-assisted radical cystectomy (RARC) for pathological T4 bladder cancer. PATIENTS AND METHODS: Retrospective evaluation of a prospectively maintained International Radical Cystectomy Consortium database was conducted for 1118 patients who underwent RARC between 2003 and 2012. We dichotomised patients based on pathological stage (≤pT3 vs pT4) and evaluated demographic, operative and pathological variables in relation to morbidity and mortality. RESULTS: In all, 1000 ≤pT3 and 118 pT4 patients were evaluated. The pT4 patients were older than the ≤pT3 patients (P = 0.001). The median operating time and blood loss were 386 min and 350 mL vs 396 min and 350 mL for p T4 and ≤pT3, respectively. The complication rate was similar (54% vs 58%; P = 0.64) among ≤pT3 and pT4 patients, respectively. The overall 30- and 90-day mortality rate was 0.4% and 1.8% vs 4.2% and 8.5% for ≤pT3 vs pT4 patients (P < 0.001), respectively. The body mass index (BMI), American Society of Anesthesiology score, length of hospital stay (LOS) >10 days, and 90-day readmission were significantly associated with complications in pT4 patients. Meanwhile, BMI, LOS >10 days, grade 3-5 complications, 90-day readmission, smoking, previous abdominal surgery and neoadjuvant chemotherapy were significantly associated with mortality in pT4 patients. On multivariate analysis, BMI was an independent predictor of complications in pT4 patients, but not for mortality. CONCLUSIONS: RARC for pT4 bladder cancer is surgically feasible but entails significant morbidity and mortality. BMI was independent predictor of complications in pT4 patients.

Impact of surgeon and volume on extended lymphadenectomy at the time of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium (IRCC).

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Lymph node dissection and it's extend during robot-assisted radical cystectomy varies based on surgeon related factors. This study reports outcomes of robot-assisted extended lymphadenectomy based on surgeon experience in both academic and private practice settings. OBJECTIVE: To evaluate the incidence of, and predictors for, extended lymph node dissection (LND) in patients undergoing robot-assisted radical cystectomy (RARC) for bladder cancer, as extended LND is critical for the treatment of bladder cancer but the role of minimally invasive surgery for extended LND has not been well-defined in a multi-institutional setting. PATIENTS AND METHODS: Used the International Robotic Cystectomy Consortium (IRCC) database. In all, 765 patients who underwent RARC at 17 institutions from 2003 to 2010 were evaluated for receipt of extended LND. Patients were stratified by age, sex, clinical stage, institutional volume, sequential case number, and surgeon volume. Logistic regression analyses were used to correlate variables to the likelihood of undergoing extended LND. RESULTS: In all, 445 (58%) patients underwent extended LND. Among all patients, a median (range) of 18 (0-74) LNs were examined. High-volume institutions (≥100 cases) had a higher mean LN yield (23 vs 15, P < 0.001). On univariable analysis, surgeon volume, institutional volume, and sequential case number were associated with likelihood of undergoing extended LND. On multivariable analysis, surgeon volume [odds ratio (OR) 3.46, 95% confidence interval (CI) 2.37-5.06, P < 0.001] and institution volume [OR 2.65, 95% CI 1.47-4.78, P = 0.001) were associated with undergoing extended LND. CONCLUSIONS: Robot-assisted LND can achieve similar LN yields to those of open LND after RC. High-volume surgeons are more likely to perform extended LND, reflecting a correlation between their growing experience and increased comfort with advanced vascular dissection.

Surgery-related complications of robot-assisted radical cystectomy with intracorporeal urinary diversion.

OBJECTIVES: To assess the surgery-related complications at robot-assisted radical cystectomy with total intracorporeal urinary diversion during our learning curve in treating 45 patients with bladder cancer. METHODS: A total of 45 patients were pooled in 3 consecutive groups of 15 cases each to evaluate the complications according to the Clavien classification. As a surrogate for our learning curve, the following parameters were assessed: operative time, blood loss, urinary diversion type, lymph node yield, surgical margin status, and length of hospital stay. RESULTS: Early surgery-related complications were noted in 40% of the patients and late complications in 30%. The early Clavien grade III complications remained significant (27%) and did not decline with time. Overall, fewer complications were observed between the groups over time, with a significant decrease in late versus early complications (P = .005 and P = .058). The mean operative times declined from the first group to the second and third groups (P = .005) and the hospital stays shortened (P = .006). No significant difference was observed between groups regarding the lymph node yield at cystectomy (P = .108), with a mean of 22.5 nodes (range 10-52) removed. More patients received an orthotopic bladder substitute (Studer) in each of the latter 2 groups than in the first. CONCLUSIONS: Although robot-assisted radical cystectomy with total intracorporeal urinary diversion is a complex procedure, we observed decreased surgery-related complications and improved outcomes over time in the present series. Our results need to be confirmed by others before robot-assisted radical cystectomy with totally intracorporeal urinary diversion can be accepted as a treatment option for patients with bladder cancer.

Analgesia during extracorporeal shockwave lithotripsy: fentanyl citrate versus parecoxib sodium.

BACKGROUND AND PURPOSE: Shockwave-induced pain may become an important issue during extracorporeal shockwave lithotripsy (SWL), although the new generation of lithotriptors generally produces less pain than previous models. The aim of the study was to compare the analgesic effect of a cyclooxygenase-2-specific inhibitor (parecoxib sodium) with that of our standard method of analgesia (fentanyl citrate) in patients who needed pain relief when undergoing SWL. PATIENTS AND METHODS: Fifty-eight patients who were undergoing SWL for renal calculi were randomized to receive intravenously either fentanyl citrate (group A, n = 30) or parecoxib sodium (group B, n = 28) when they felt that their pain during the session became intolerable. Lithotripsy was recommenced 10 minutes after administration of analgesia. The severity of pain before and after administration of the analgesic regimens was evaluated using a five-level verbal scale. The effectiveness of each drug was evaluated with respect to degree of pain relief and ensuing tolerance of the procedure to completion, as well as the need for supplementary analgesia (half the standard dose of fentanyl citrate). RESULTS: The patients in the two groups were comparable with regard to age, sex, body mass index, and stone size. There was no statistically significant difference in the maximum energy level achieved as well as in the total number of shock waves given in the two groups. Administration of fentanyl citrate resulted in alleviation of pain and completion of SWL in 27 patients (90%), whereas parecoxib sodium was effective in five patients (17.8%) (P < 0.01). The remaining 23 patients in group B received supplementary analgesia, and 22 completed the lithotripsy session. CONCLUSIONS: Parecoxib sodium was not as effective as fentanyl citrate in alleviating pain during SWL. Its use, however, may lower the dose of opioid-based analgesia in this group of patients.

Laparoscopic radical prostatectomy in men older than 70 years of age with localized prostate cancer: comparison of morbidity, reconvalescence, and short-term clinical outcomes between younger and older men.

OBJECTIVES: To analyze the safety and efficacy of extraperitoneal laparoscopic radical prostatectomy (eL-RPE) in elderly versus younger men with localized prostate cancer. METHODS: Patients undergoing eL-RPE were retrospectively subdivided into group eL-RPE1 (72 men aged 71 yr and older) and group eL-RPE2 (132 men aged 59 yr and younger). Group eL-RPE1 was compared with a group of 70 contemporary, comparable patients aged 71 yr and older undergoing open retropubic radical prostatectomy (group OPEN-RPE). RESULTS: Compared with group eL-RPE2, patients of group eL-RPE1 had a higher pathologic stage (45% vs. 32% stage pT3 or greater, p<0.001) and higher Gleason score (median 7 vs. 6, p<0.001). Prostate-specific antigen recurrence was significantly worse compared with age-matched controls for younger patients with high-stage or high-grade lesions (p<0.001). Importantly operative time, analgesic requirements, hospital stay, convalescence, and complication rates were comparable. Urinary continence rate was significantly better in group eL-RPE2 at 6 mo (67% vs. 91%, respectively, p<0.001). Group eL-RPE1 and group OPEN-RPE patients had statistically similar pathologic stage and Gleason score (each p>0.05), similar operative time (p=0.12), but less blood loss (p<0.001), shorter hospital stay (p<0.001), and more rapid convalescence (p<0.001) occurred in eL-RPE1. CONCLUSIONS: eL-RPE is feasible and efficacious even in elderly patients with unfavorable, large-volume disease. eL-RPE offers the advantages of decreased blood loss, shorter hospital stay, and more rapid recovery over OPEN-RPE. However, the elderly patient must be informed preoperatively about the observed higher incontinence rate.

Vesicourethral anastomosis during endoscopic extraperitoneal radical prostatectomy: a prospective comparison between the single-knot running and interrupted technique.

OBJECTIVES: To determine the safety and efficacy of the single-knot running versus interrupted technique for urethrovesical anastomosis during endoscopic extraperitoneal radical prostatectomy. METHODS: A total of 250 consecutive patients who underwent endoscopic extraperitoneal radical prostatectomy were prospectively divided into two groups of 125 patients each who underwent urethrovesical anastomosis using the single-knot running technique (group 1) or the interrupted suture technique (group 2). Surgical data, operative time, difficulty scores, extravasation rate, catheterization time, occurrence of anastomotic strictures, and the early and late continence rates were analyzed statistically. RESULTS: Regarding the clinical and pathologic findings, extravasation rate, catheterization time, and occurrence of anastomotic strictures, no significant differences were found between the two groups (P >0.05). The strongest independent predictors for extravasation were the integrity of the dorsal wall of the anastomosis and the degree of bladder neck opening (P <0.001). Overall, the continence rate at 3 and 6 months was 76% and 91.5% for group 1 and 77.6% and 93% for group 2, respectively (all P >0.05). The anastomosis technique had no impact on extravasation or continence status (all P >0.05). The only significant differences (P <0.001) in favor of the single-knot technique were the mean operative time and difficulty score (16 versus 24 minutes and 1 versus 3, respectively). CONCLUSIONS: Both techniques provide satisfactory and similar functional results. However, because of its simplicity and shorter operative time, the single-knot running technique appears preferable.

Quality of life after laparoscopic and open retroperitoneal lymph node dissection in clinical Stage I nonseminomatous germ cell tumor: a comparison study.

OBJECTIVES: To compare the postoperative quality of life (QOL) and reconvalescence in patients with clinical Stage I nonseminomatous germ cell tumor (NSGCT) after laparoscopic retroperitoneal lymph node dissection (L-RPLND) and the open procedure (O-RPLND). METHODS: Twenty-one patients with NSGCT who underwent transperitoneal L-RPLND were matched and compared with 29 patients who underwent O-RPLND. The operative, QOL, and recovery data and complications and cure rates were analyzed for both groups. RESULTS: The mean follow-up time for the L-RPLND and O-RPLND groups was 14 months (range 6 to 20) and 26 months (range 8 to 38), respectively. No major complication requiring open surgical revision or prolongation of hospitalization was observed intraoperatively or postoperatively in either group. However, the early and late minor postoperative complications were significantly greater in the O-RPLND group than in the L-RPLND group (P <0.001). The L-RPLND patients had a significantly shorter hospitalization, greater QOL scores, and a faster return to normal activities than did the O-RPLND patients (all P <0.001). CONCLUSIONS: L-RPLND for patients with clinical Stage I NSGCT is a safe and efficacious procedure, with a faster reconvalescence and greater postoperative QOL than after O-RPLND.

Treatment of renal-vascular injury by transcatheter embolization: immediate and long-term effects on renal function.

PURPOSE: To evaluate the impact of superselective embolization for treatment of renal-vascular injuries on renal function. PATIENTS AND METHODS: Between 1995 and 2004, four male patients and one female patient with a mean age of 45.4 years underwent embolization to control bleeding from renal-vascular injuries resulting from iatrogenic interventions (N = 4) or blunt abdominal trauma (N = 1). Angiography depicted a pseudoaneurysm in all patients, together with an arteriovenous fistula in one. Superselective embolization was achieved with 0.035- or 0.018-inch coils combined with a mixture of Histoacryl and Lipiodol in one patient. RESULTS: Bleeding was controlled in all patients and did not recur. No complications occurred after the procedure. Hematuria ceased within 3 days. The serum creatinine concentration returned to pre-injury values within 10 days. Embolization caused an immediate parenchymal ischemic area of 0 to 20% (mean 9%). The contrast-enhanced CT scan 6 months after the procedure revealed a parenchymal perfusion deficit of 0 to 10% (mean 5%). CONCLUSIONS: Superselective embolization resulted in permanent cessation of bleeding. Renal function was preserved in all the patients, and serum creatinine concentrations returned to the pre-injury values. Transcatheter embolization should be considered the treatment of choice in the management of renal-vascular injuries.

Induction of spermatogenesis in men with azoospermia or severe oligoteratoasthenospermia after antegrade internal spermatic vein sclerotherapy for the treatment of varicocele.

AIM: To evaluate the treatment outcome of antegrade internal spermatic vein sclerotherapy in men with non-obstructive azoospermia or severe oligoteratoasthenospermia (OTA) as a result of varicocele. METHODS: Between September 1995 and January 2004, 47 patients (mean age 33.8 +/- 6.3 years) underwent antegrade internal spermatic vein sclerotherapy for the treatment of varicocele with azoospermia (14 patients) or severe OTA (33 patients). Testicular core biopsy was also performed in complete azoospermic patients who provided informed consent. The outcome was assessed in terms of improvement in semen parameters and conception rate. RESULTS: Forty-two (89.4%) of 47 patients had bilateral varicocele. Serum follicle stimulating hormone (FSH) did not differ between patients with azoospermia and severe OTA. After the follow-up of 24.8 +/- 9.2 months, significant improvement was noted in mean sperm concentration, motility and morphology in 35 patients (74.5%). Comparison between groups during the follow-up revealed significantly higher values of sperm concentration, motility and normal morphology in the severe OTA group. Pregnancy was achieved in 14 cases (29.8%). Testicular histopathology of the azoospermic patients with postoperative induction of spermatogenesis revealed maturation arrest at spermatid stage, Sertoli-cell-only (SCO) with focal spermatogenesis or hypospermatogenesis. None of the patients with pure SCO pattern or maturation arrest at spermatocyte stage achieved spermatogenesis after the treatment. Preoperative serum FSH levels didn't relate to treatment outcome. CONCLUSION: Antegrade internal spermatic vein sclerotherapy is an easy and effective treatment for symptomatic varicocele. It can significantly reverse testicular dysfunction and improve spermatogenesis in men with severe OTA, as well as induce sperm production in men with azoospermia, improving pregnancy rates in subfertile couples.

Laparoscopic radical prostatectomy: impact of modified apical and posterolateral dissection in reduction of positive surgical margins in patients with clinical stage T2 prostate cancer and high risk of extracapsular extension.

PURPOSE: To determine whether modifications of extraperitoneal endoscopic radical prostatectomy (EERP) reduce the rate of a positive surgical margin (PSM) in men with clinical stage T(2) prostate cancer and a high risk of extracapsular extension. PATIENTS AND METHODS: A consecutive series of 182 men with stage cT(2) tumors and a high risk of extracapsular extension underwent EERP by a single surgeon (VP). The patients were divided into two groups: 71 patients who underwent a standard EERP (group 1) and 111 patients who underwent EERP with the modified technique (group 2). The basic principles of the modified technique are more thorough and wider resection of the posterolateral prostatic pedicles and extensive excision of periprostatic soft tissue at the apex, which results in better mobilization and exposure of the apex before the urethral transection. Differences in PSM rates were analyzed statistically. RESULTS: No significant differences were found between the two groups regarding the clinical and pathologic findings (P > 0.05). The rate of PSM was 28% in group 1 and 10% in group 2 (P < 0.001). Group 2 was less than one third as likely to have PSM as group 2 (odds ratio 2.9; 95% confidence interval 1.6, 3.9). The strongest (P < 0.0001) independent predictors of PSM were the surgical technique, the presence of extracapsular disease, and the volume of the cancer. Preservation of the neurovascular bundles had no impact on margin status (P = 0.93). Functional outcomes and complication rates were not adversely affected by these modifications. CONCLUSION: The modified dissection in EERP significantly reduces the rate of PSM in patients with stage cT(2) prostate cancer and a high risk of extracapsular extension.

Extracorporeal shockwave therapy for Peyronie's disease: an alternative treatment?

AIM: To determine retrospectively the safety and efficacy of extracorporeal shock wave therapy (ESWT) in patients with Peyronie's disease. METHODS: Fifty-three patients with stable Peyronie's disease underwent ESWT (group 1). Fifteen patients matched with the baseline characteristic of the patients in group 1, who received no treatment, were used as the control (group 2). The patients' erectile function (International Index of Erectile Function [IIEF-5] score), pain severity (visual analog scale), plaque size and degree of penile angulation were assessed before and after the treatment in group 1 and during the follow-up in group 2. RESULTS: The mean follow-up time was 32 months (range: 6-64 months) in group 1 and 35 months (range: 9-48 months) in group 2. All the patients were available for the follow-up. Considering erectile function and plaque size, no significant changes (P > 0.05) were observed in group 1 before or after the ESWT. A total of 39 patients (74%) reported a significant effect in pain relief in group 1 after ESWT. However, regarding improvement in pain, IIEF-5 score and plaque size, no significant differences were observed between the two groups. In 21 patients (40%) of group 1, the deviation angle was decreased more than 10 degrees with a mean reduction in all patients of 11 degrees (range: 6-20 degrees). No serious complications were noted considering ESWT procedure. CONCLUSION: ESWT is a minimally invasive and safe alternative procedure for the treatment of Peyronie's disease. However, the effect of ESWT on penile pain, sexual function and plaque size remains questionable.

Intensive laparoscopic training: the impact of a simplified pelvic-trainer model for the urethrovesical anastomosis on the learning curve.

We prospectively evaluated the learning curve (LC) for laparoscopic urethrovesical anastomosis (L-UVA) in an operator-training model and program using an innovative simplified pelvic-trainer model. Over a period of 12 months, 30 LRP were performed by one urologist skilled in open surgery but inexperienced in laparoscopy. During the first 15 procedures no systematic training was done. Consequentially, a systematic simplified daily program was performed on the pelvic trainer with a videolaparoscopic unit. The training lesson consisted of intracorporal knotting and suturing, linear and circular interrupted suture anastomosis. At the end of each lesson, time and performance error scores were recorded and progression curve was plotted for each task. The performances of each training tasks were plotted against the performance of L-UVA during the LRP. The significance of progression was evaluated using logarithmic regression analysis. A steady improvement in time and accuracy of performance skill was shown during the first 20 lessons (p<0.001). These improved skill acquisitions were proportionally correlated with the time and the accuracy (water-tight) of L-UVA performance during the last 15 L-RPE. Compared to the first 15 L-RPE, where no systematic training was performed, time and accuracy of L-UVA performance in the last 15 L-RPE were improved from a mean 51 (median 48, range: 38-75) to 26 (median 24, range 18-33) min (p<0.001) and from 10 to 15 watertight anastomoses (p<0.001), respectively. Using a continuing, systematic, simplified training model the LC of L-UVA can be improved significantly in a short time.

Tension-free vaginal tape (TVT) in morbidly obese patients with severe urodynamic stress incontinence as last option treatment.

OBJECTIVES: To determine the safety and efficacy of tension-free vaginal tape (TVT) in morbidly obese women with severe urodynamic stress incontinence (USI) as last option treatment. METHODS: Thirty-one patients with body mass index (BMI) >40 kg/m2, who had undergone the TVT procedure for urodynamically-confirmed USI were matched with 52 patients with BMI <30 kg/m2 who underwent the same procedure. BMI was calculated at the time of the surgery. Patients' characteristics and surgical data, complications and cure rates were analyzed for both groups. RESULTS: After a mean follow-up of 18.5 (range: 12-24) months the continence rates were 87% and 92% for morbidly obese women and control group, respectively (p = 0.103). No serious intraoperative complications were noted in both groups. However, the early postoperative complications were significantly higher (p < 0.05) in morbidly obese patients. In 4 patients from both group long term postoperative catheterization was necessary for 4 weeks. In one patient (2%) from the control group dilatation of urethra took place. No defect in healing or rejection of the tape occurred. CONCLUSIONS: TVT is a minimal invasive and safe procedure for morbidly obese patients suffering from severe USI with good outcome. Preoperative morbid obesity does not seem to be a risk factor for failure of this procedure.