Search

Studies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes. One hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust®, MiniArc®, or TVT Secur System®). Duration of follow-up was at least 24 months from surgery. The primary outcome was the subjective cure rate at 24 months from surgery; secondary outcomes were rates of total failure and reoperations for UI. At study end, no difference was detected between groups in terms of total subjective cure rate [21 (52.5 %) vs. 26 (65.0 %) vs. 21 (52.5 %), in Ajust®, MiniArc®, and TVT Secur System® group, respectively; P = 0.412] or in terms of total failure rate [24 (60.0 %) vs. 22 (55.0 %) vs. 27 (67.5 %), in Ajust®, MiniArc®, and TVT Secur System® group, respectively; P = 0.432]. The proportion of patients who received a second surgery for UI was also not significantly different between groups [13 (32.5 %) vs. 10 (25.0 %) vs. 13 (32.5 %), in Ajust®, MiniArc®, and TVT Secur System®, respectively; P = 0.831]. The long-term efficacy of SIMS does not differ between the vaginal kits examined.

During the last century various loop operations are used in the treatment of stress urinary incontinence. Methods for treating urinary incontinence are inextricably linked with the development of urology as a science. Dominance concept of sphincter deficiency as the main cause of urinary incontinence led to the use of various muscle loops, which was considered by many authors, could carry the functional load. The last decade was marked by significant developments and achievements in the treatment of urinary incontinence in women. Data received today entitle say that, in general, the use of synthetic loops installed without tension in the middle of the urethra, to get rid of urinary incontinence significant number of patients with this medical and social problem worldwide. We can say that with the advent of SIMS and their use in the treatment of urinary incontinence, a new stage. The concept of using SIMS for implantation which the surgeon requires one incision under the middle third of the urethra, is not innovative. So Smith presented his minisling made of pig skin in 1987. First available for use SIMS became minisling TVT Secur company Gynaecare (Ethicon) in 2005. To date, there are many SIMS: TVT Secur®, MiniArc®, Ophira®, Adjust®, Solyx®, Zipper Sling®, Prosurg®, Tissue Fixation System®, Needleless®, Altis®, Just-swing®, Desara®. Many manufacturers do not stop and continue to develop new minislingi with new locking mechanisms.

This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence. We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n = 56) or TVT-O (n = 50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal–Wallis, Wilcoxon, and Fisher’s exact tests as appropriate. P values of

Background The prevalence of stress urinary incontinence (SUI) in the middle-aged Indian women is around 16%. The use of transvaginal tapes (TVTs) has revolutionised the surgical management of SUI. Patients who undergo placement of the tape via the transobturator route often complain of persistent thigh pain at the site of trocar insertion. The use of minimally invasive tapes with a single suburethral incision reduces surgical trauma by eliminating thigh incisions, while maintaining the cure achieved by conventional TVTs. The study was conducted to test the efficacy and safety of minimally invasive TVT-Secur tape placement for treatment of SUI in women. Methods 20 women with stress incontinence were implanted with TVT-Secur tapes and followed up for a year. Results The objective cure rate of SUI was 85% at the end of a year. The improvement in the patient satisfaction and Incontinence-specific QOL scores, of both Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7), was statistically significant at 95% and 99% confidence levels. There were no complaints of thigh pain; however, there were intraoperative complications in the form of bladder perforation in 5% ( n = 1), urethral injury in 5% ( n = 1) and urethral tape exposure in 10% ( n = 2), at 3 months requiring tape sectioning. Conclusions These cure rates and complications are comparable to the standard TVT implantations at the end of a year, without thigh pain; however, a greater number of patients and a longer follow-up is required to see whether the long-term cure is maintained or not, before recommending the same as a standard of treatment.

To review the most recent studies comparing single incision slings (SISs) with conventional mid-urethral slings (CMUSs) for treatment of female stress urinary incontinence (SUI). A search in Pubmed and ISI Web of Knowledge was made using words referred to SUI and SISs. Only randomized clinical trials (RCTs) described in full-length papers published after the meta-analysis by Abdel-Fattah and co-workers (Eur Urol 2011;60(3):468-480) were considered. Six studies were identified, including a quasi-RCT. TVT-Secur was compared against CMUSs in three papers. Contasure-Needleless and Tissue Fixation System (TFS) were compared with a CMUS in one study each. Miniarc and TVT-Secur were compared against a CMUS in one trial. One additional study compared three SISs (Miniarc, TVT-Secur, Ajust). RCTs with Miniarc, TVT-Secur placed in the vertical position, Contasure-Needleless and TFS, show success rates similar to CMUSs. Consistently, complications favour SISs. These studies support the use of some SISs to treat female SUI.

Background: Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity. Objective: Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS. Design, setting, and participants: Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded. Interventions: Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc. Measurements: Postoperative visits were scheduled at 6 and 12 mo. The King’s Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated. Results and limitations: Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur. TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo. Conclusions: Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option.

The purpose of the study was to evaluate and compare the clinical values of tension-free vaginal tape (TVT), tension-free vaginal tape-transobturator (TVT-O), or tension-free vaginal tape-Secur (TVT-Secur) as treatment for female stress urinary incontinence.The pre-operative and 1-year post-operative follow-up protocols for patients who were treated with serial mid-urethral tension-free tape procedures in two hospitals from October 2008 to December 2009 were prospectively studied. These patients were randomly allocated to TVT, TVT-O, or TVT-Secur.A total of 102 women participated. At the 1-year follow-up, complications were not statistically different across the three groups except for pain in the thigh, which was more common in the TVT-O group. The overall efficacy and cure rate were similar between the TVT and TVT-O groups, but were significantly lower in the TVT-Secur group.A comparison of the three procedures shows that TVT-O is easy to operate and is as safe as TVT-Secur, and it has similar long-term efficacy to TVT, though, as one of the third-generation mid-urethral tension-free tapes, TVT-Secur is still being evaluated. Basing on the outcome of our study, it had rare complications but unsatisfactory efficacy, and we suggest that TVT-Secur is not fit for severe cases. However, observation and comparison of these groups in a larger sample size on a longer term are needed.

To reduce complications of transobturator tension-free vaginal tape, single-incision devices were introduced in the last years. We here report a comparison between the tension-free vaginal tape-obturator (TVT-O) and the TVT-Secur techniques in terms of efficacy and safety.Eighty-four patients with stress urinary incontinence (SUI) were scheduled to undergo TVT-O or TVT-Secur. Duration of the procedure, subjective estimate of blood loss, intraoperative and postoperative complications, postoperative postvoidal residue (PVR), time to first voiding, and pain level were recorded. Urodynamic tests, PVR, Incontinence Questionnaire Short Form (ICIQ-SF), King's Health Questionnaire, and a urinary diary were performed before and 12 months after procedure.No differences in terms of cure rate were observed between the two groups (81.6% vs. 83.8%). Complication rate in the TVT-Secur group was lower (8.1%) than in the TVT-O group (15.8%), but not significant.Both techniques seem to be effective and safe, with a low incidence of complications in both groups.

Purpose: We compared the efficacy and safety of two minimally invasive sling procedures used to treat female stress urinary incontinence (SUI), tension-free vaginal tape (TVT) SECUR ® and CureMesh ® , and assessed the 1-year surgical outcomes. Materials and Methods: Sixty women with SUI were assigned to undergo either the TVT SECUR (n=38) or CureMesh (n=22) procedures between April 2007 and June 2008. Patients were monitored via outpatient visits at 1 month, 3 months, and 1 year after surgery. The efficacy of these procedures was evaluated by the cough test or by a urodynamic study. At these postoperative visits, the patients also completed several questionnaires, including incontinence quality of life, patient’s perception of urgency severity, the scored form of the Bristol Female Lower Urinary Tract Symptoms, visual analog scale, and questions about perceived benefit, satisfaction, and willingness to undergo the same operation again. The objective cure rate was defined as no leakage during the cough test with a full bladder. The subjective cure rate was evaluated by self-assessment of goal achievement performed 1 year postoperatively. Results: The two groups were similar in preoperative characteristics and urodynamic parameters. The objective cure rates were similar between TVT SECUR and CureMesh (68.4% vs. 77.3%). All respondents reported improvement after surgery. There were no intra-operative complications. Conclusions: Our results showed that the TVT SECUR and CureMesh procedures are both safe and simple to perform and have no significant differences in efficacy. Comparative studies with long-term follow-up are warranted to determine the true efficacy of these procedures.

Objectives: Tension-free vaginal tape (TVT)-SECUR is a technique specifically designed to place a short suburethral mesh sling for the treatment of female stress urinary incontinence (SUI). The aim of the technique is to decrease surgical morbidity. We report our experience of applying this technique on 10 patients. Methods: From June 2007 to July 2007, 10 female patients with SUI underwent TVT-SECUR placement operation. The sling was inserted in a suprapubic direction over the inner surface of pubic bone (U-shaped technique). Nine of the patients underwent videourodynamic study (VUDS). The maximal bladder neck decent distance (MBND) by abdominal straining was determined. We identified intrinsic sphincter deficiency (ISD) as a valsalva leak point pressure lower than 60 cm H2O and hypermobility as MBND more than 2 cm. Results: Two patients had pure ISD, three had hypermobility, and four had both ISD and hypermobility. All patients remained continent for first month after surgery. SUI recurred in five of nine patients at an average of 2.5 months. The recurrence appeared in all three groups of patients. The recurrent SUI was so severe that three patients required repeat surgery using percutaneous prolene tape sling. After surgery, no further SUI was noted in the three patients. During surgery the TVT-SECUR sling was found to have firmly adhered to perivesical tissue rather than to the pubic bone. Conclusion: Our experience shows that the current design of the TVT-SECUR results in unpredictable outcomes. Some placed slings may migrate away from the inner surface of the pubic bone. To act as a reliable “hammock”, the sling must be securely fixed on immobile structures independent from the bladder/urethra.

The objective of this study is to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure. This was a prospective multi-centre trial. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the TVT-secur procedure. The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS), Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on quality of life (QoL) and to measure patient's perception of incontinence severity and improvement. The SPSS software was used for data analysis. From November 2006 to September 2007, 95 consecutive patients were enrolled in the study. At 1 year, 91 patients were available for the analysis. The subjective and objective cure rates were 78% and 81%, respectively. The ICIQ-SF and W-IPSS symptoms score showed a statistically significant decrease. Post-operative complications included voiding difficulty, recurrent UTI, de novo urgency incontinence and dyspareunia. Our data show that TVT-secur is associated with an 80% success rate at 1 year.

In recent years, surgical treatment of stress urinary incontinence has become minimally invasive owing to the introduction of the transobturator route first and then single incision devices for positioning of mid-urethral slings. Although a number of case reports in the literature describe pregnancies successfully terminated both by vaginal delivery and cesarean section following mid-urethral sling positioning, there is still no definitive consensus on which is the preferred mode of delivery in these patients. We report a case of spontaneous vaginal delivery at term in a 41-year-old multiparous woman two years after the positioning of a single incision sling (TVT-Secur). The patient remained continent throughout the gestation and in the following 24 months. This case seems to further support the concept that sling procedures for stress urinary incontinence do not represent an absolute contraindication to spontaneous vaginal delivery, although the preferred mode of delivery must be assessed on an individual basis.

We report a serious bleeding complication due to injury of the corona mortis following insertion of a transvaginal tape, TVT-Secur™ (Ethicon Women's Health, Sommerville, NJ, USA).The TVT-Secur™ was inserted using the U-Approach: the tape was pushed along the periost behind the arc of the pubic bone at an angle of 45°.Surgery was unproblematic. Four hours after surgery, the patient showed shock signs; a CT scan revealed a 13.5 × 9.5-cm-sized retrosymphysic haematoma. Instant laparotomy with removal of the large haematoma, ligation of the bleeding corona mortis and administration of erythrocyte concentrates were necessary.The corona mortis is an anastomosis between the arteria obturatoria and the external iliac vessels or its branches that passes over the superior pubic ramus. Its prevalence and anatomical relation to the pubic bone are important to bear in mind when applying new surgical techniques.

Various postoperative complications have been reported after the use of tension-free vaginal tapes (TVT). The transobturator approach was introduced to minimize the potential complications. The next generation of recently introduced TVT-SECUR is intended to minimize the incidence of complications. Herein we report a case of internal pudendal artery injury sustained during this procedure that was successfully treated by radiological embolization. Angiography with vessel embolization, when available, should be considered when the arterial injury is suspected.

We report a serious complication following a TVT-Secur procedure due to injury of the corona mortis requiring a surgical intervention for removal of 1 l of clotted blood from the space of Retzius. The corona mortis is an anomaly of the vessel combining the obturator and epigastric arteries passing over the superior pubic ramus, well known to hernia and orthopedic surgeons but probably less well known to gynecological surgeons.

A rare but challenging complication of midurethral tape procedures is perforation of the tape through the bladder wall. We saw three patients in whom unrecognized bladder perforation during TVT-Secur™ procedures occurred. It took an average follow-up time of 11 months before the bladder perforations were identified by introital ultrasound. Complete excision of the mesh was achieved endoscopically (TURP resectoscope) and/or by traditional vaginal tape removal techniques. Following tape removal, there has been no recurrence of urinary tract infections, and the irritative voiding symptoms have resolved in all three cases. Bladder perforation after mini-sling procedures can be managed using a combined transurethral/vaginal approach. This technique is minimally invasive, safe, and successful. Careful introital ultrasound should be performed in patients presenting with new lower urinary tract symptoms after sling surgery to avoid delays in diagnosing bladder perforation.

INTRODUCTION The TVT-Secur, a single incision sling, was introduced in 2006. It is implanted using either the "hammock" or the "U-method" technique. With the latter, the sling is tightened to create a "pillowing effect" on the urethra until a negative stress test is obtained. Short-term results seem promising. However, no study has ever reported on the voiding pattern 12 months after its implantation. Our objective was to assess whether the "U-method" technique creates an obstructive voiding pattern on pressure-flow study (PFS) 12 months after the surgery. METHODS In this retrospective study, we reviewed the charts of 33 women who underwent the "U-method" TVT-Secur. Patients were evaluated before and 12 months postoperatively with regard to different urodynamic studies (UDS). The incontinence status was also assessed 12 months after surgery. RESULTS At 12 months after the operation, 12.5% (4/32) of the patients reported an improvement of their stress urinary incontinence, while 78.1% (25/32) reported being cured from it. The objective cure rate was 63% (19/30). One patient had a suspected bladder outlet obstruction (BOO) based on PFS. Maximal flow rate (Q(max)) was significantly lower 12 months after surgery (26.0 mL/s [range: 19.0-36.5] vs. 21.5 mL/s [range: 16.0-32.3]). However, median voided volume was lower on the postoperative uroflowmetry (446 mL [range: 348-605] vs. 320 mL [range: 243-502]). Furthermore, none of the patients complained of voiding symptoms after surgery. CONCLUSIONS Although one patient had findings compatible with BOO, none complained of voiding symptoms. TVT-Secur may result in a lower Q(max). However, this finding may be due to a lower voiding volume on the postoperative UDS.

INTRODUCTION AND OBJECTIVES: Early results of single incision mid-urethral sling, tension-free vaginal tape (TVT)-Secur® procedure were reported about 66-88% success rate. However, there was little report about long-term results of TVT-Secur procedure. The aim of this study was to assess the efficacy and complications associated with the TVT-Secur system device through the follow-up at 3-year after the procedure. METHODS: One hundred and fifteen women with SUI underwent TVT-Secur(Gynecare Inc, Menlo Park, CA, USA) by a single surgeon were followed at 1, 2 and 3 years after the surgery. Patients were randomly assigned to either the Uor the H-type approach. Postoperative changes in the Sandvik questionnaire, postoperative patientsi benefit, satisfaction and willing to take same procedure questionnaire were evaluated at each follow up. Cure was regarded as no leakage on the Sandvik questionnaire. Complications were evaluated. RESULTS: Of 115 women, 102 patients were followed at 3 years after the operation. (47 patients: U-type, 55: H-type) Mean age was 56 9 years old and mean disease duration was 62.4 80.8 months. (U: 52.6 months, H: 70.6 months) The overall cure rate based on the sandvik questionnaire was 79.4% (81/102) at 3-year follow-up. Eighty-nine percent (42/47) of patients treated with the U-type and 70.9% (39/55) of those treated with the H-type were cured. That result was same pattern compared with the results of 1 and 2 year follow-up. Eighty-nine percent of those treated with the U approach and 87.1% of those treated with the H approach were cured at 1-year follow-up. (p 0.796) The cure rate of U-type was higher than that of H-type, but there was no statistically significance. (Table) Only 12.7% of patients used pads at 3-year follow-up and 8.8% of patients were experienced urgency over than once a week. Eighty-six percent of total patients stated they had benefit from the operation. Eighty-two percent of the patients were satisfied with the treatment and 86% of all patients stated that they would undergo the procedure again under the same circumstances. Eighty-four percent of the patients would recommend this treatment to a friend with the same condition. CONCLUSIONS: The Uand H-type approaches of the TVTSecur procedure provided comparable effectiveness for the treatment of female SUI at 3-year follow-up after the operation.

To evaluate the mid-term efficacy and safety of the TVT-Secur device in the treatment of stress urinary incontinence. Retrospective study evaluating 68 women affected by stress urinary incontinence treated with TVT-Secur procedure with hammock approach who attended the 24-month follow-up visit. Stress test, urodynamics, patient functional and quality of life questionnaires, visual analog scale pain score, and post-operative complications were evaluated. Data distribution was evaluated using the Shapiro–Wilk’s test. Data were analyzed by the Student’s t test for parametric variables, the Wilcoxon test for non-parametric variables, and the Chi-squared test for categorized variables. Objective cure rate 24 months after surgery was 80.8 %. Incontinence-quality of life and patient global impression of severity scores showed significant improvement. The only intra-operative complications were a vaginal wall tear and a case of severe bleeding, while post-operative complications were de novo urgency in five cases (7.3 %), one acute urinary retention (1.4 %), and one tape exposure (1.4 %). The study is limited by the retrospective design and the heterogeneity of patients. TVT-Secur seems to be an effective and safe procedure for stress urinary incontinence.

The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI). This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked “Never”/“Urine does not leak” in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented. One hundred ninety-seven women with proven SUI were randomized into three groups—TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p

PURPOSE As recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress urinary incontinence (SUI) during 2 years. MATERIALS AND METHODS We evaluated 51 patients with clinical and urodynamic diagnoses of SUI who underwent the TVT-S procedure from March 2008 to February 2009. Preoperative evaluation included a history, cough stress test with full bladder, urodynamic study, and incontinence quality of life (I-QoL) questionnaire. Following the postoperative period, urinary incontinence status was examined through a physical examination and the I-QoL questionnaire was completed in an outpatient setting or by telephone. RESULTS Data from 2 years of follow-up were available for 46 of 51 patients. The cure rate was 80.4% at 1 month after TVT-S and 76.0% at 2 years after TVT-S. The cure or improvement rate was 93.5% at 1 month after TVT-S and 86.8% at 2 years after TVT-S. The mean total I-QoL score increased by 42 points at 1 month after TVT-S (p

This is an observational multicentre prospective study into the complications and effectiveness of TVT SECUR™. One hundred forty-seven patients with urodynamic or occult Stress Urinary Incontinence (SUI) were enrolled. Outcome measures at 6, 12 and 24 months were: objective cough test; subjective responses to PGI-S questionnaire and Visual Analogue Score. Statistical analysis: Wilcoxon Test; Monte Carlo Exact Test. Ninety-five urodynamic SUI and 41 occult SUI patients were treated using transobturator (H-position) or retropubic (U-position) approach (110 vs. 26 patients). Cure rates at 6, 12, and 24 months were 87.5%, 88.6% and 89.5%. Failure rates at all follow-ups were similar for urodynamic and occult SUI. The U-position failure rate was comparable to H-position at short-term but significantly higher at mid-term. Familiarity with the technique brought significantly higher success rates. TVT SECUR™ is safe, effective and versatile, but has an appreciable learning curve.

Background Retropubic hematomas may complicate up to 4.1% of tension-free vaginal tape (TVT) procedures in the surgical treatment of stress urinary incontinence. Symptomatic or expanding hematomas often require intervention, usually accomplished through an abdominal incision. Case A 43-year-old woman underwent transvaginal management of venous bleeding and evacuation of a 1500-mL retropubic hematoma after a TVT Secur or "mini-sling" procedure. Conclusions Significant bleeding can complicate even the least invasive surgical approach to treat stress urinary incontinence. Transvaginal evacuation of a symptomatic retropubic hematoma with instillation of a hemostatic agent may be a safe alternative to laparotomy in a hemodynamically stable patient.

TVT-Secur has been described as a new minimally invasive sling for women's stress urinary incontinence (SUI) management, showing promising results in short-term studies.Our goal was to evaluate the outcome of this procedure after a midterm follow-up.A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP).Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon.Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I scoreor = 2; as improved in case of reduction of SUI symptoms50% and PGI-I scoreor = 3; and as failure otherwise.Mean postoperative follow-up was 30.2 +/- 9.8 mo (range: 11-40 mo). Short-term evaluation showed a 93.5% success rate, but, at last follow-up, only 18 (40%) patients were cured, while 8 (18%) were improved, and 19 (42%) failed. Twelve patients underwent implantation of TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group.Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women.

Purpose: We compared outcomes of the U- and H-type approaches of the tension-free vaginal tape (TVT)-Secur procedure for the treatment of female stress urinary incontinence (SUI). Materials and Methods: From March 2007 to July 2008, 115 women with SUI underwent TVT-Secur by a single surgeon. Patients were randomly assigned to either the U- or the H-type approach. After 12 months, postoperative changes in the Sandvik questionnaire, incontinence quality of life questionnaire (I-QoL), Bristol female lower urinary tract symptoms-scored form (BFLUTS-SF), and postoperative patient satisfaction were evaluated. Cure was regarded as no leakage on the Sandvik questionnaire. Complications were also evaluated. Results: Of 115 women, 53 were treated with the U approach, and 62 women were treated with the H approach. At 12 months, 88.7% of those treated with the U approach and 87.1% of those treated with the H approach were cured (p=0.796). The I-QoL and filling, incontinence, sexual function, and QoL sum (BFLUTS-SF) scores were improved with both approaches, and there were no significant differences in the degree of improvement between approaches. Approximately 83.7% and 82.9% of the women treated with the U and H approaches, respectively, were satisfied with the outcome (p=0.858). There were 3 cases of intra-operative vaginal wall perforation in the H-type group. Immediate postoperative retention was observed in 2 women in the U-type group and 1 woman in the H-type group. One woman in the U-type group underwent tape releasing and cutting procedures for persistent large post-void residuals. Conclusions: The U- and the H-type approaches of the TVT-Secur procedure provided comparable effectiveness for the treatment of female SUI.

Background No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure. Objective Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI). Design, setting, and participants Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study. Intervention Subjects were randomly allocated to either the U- or H-type method of TVT-S. Measurements Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients' satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods. Results and limitations Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method ( p =0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method ( p =0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients' satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods. Conclusions Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method. Trial registration The protocol of this study was not registered.

OBJECTIVES To observe the satisfaction of local anesthesia during the implantation of the tension-free vaginal tape (TVT)-SECUR (Gynecare, Ethicon, Somerville, NJ) for the treatment of stress urinary incontinence, using questionnaires completed by the patients, and to evaluate the short-term safety and efficacy of the sling. METHODS Forty-eight women were operated between January 2007 and October 2008. The implantation of the TVT-SECUR was done under local anesthesia by 1 surgeon. The "Hammock" technique was used in the first 23 patients and the "U-Method" in the last 25 patients. RESULTS Mean patient age was 61 years (range, 38-85). Visual analogue scale for pain immediately and 1 week after surgery showed a mean score of 19/100 and 29/100, respectively. Overall, 93% (43/46) of the patients would recommend this type of anesthesia. At 1 week, 2 months, and 6 months after surgery, the improvement in incontinence symptoms rate was 82% (18/22), 76% (16/21), and 69% (11/16) for the Hammock technique, compared with 75% (18/24), 92% (22/24), and 100% (22/22) for the U-Method. At 6 months, the difference was statistically significant (P = .0087). Postoperative complications included 6 partial tape exposures, all with the Hammock technique. CONCLUSIONS Local anesthesia with light sedation represents an appropriate choice for the implantation of this new sling. The TVT-SECUR using the U-Method appears to be relatively safe, and the short-term efficacy rates seem to compare with traditional midurethral slings, with long-term efficacy still to be determined. This is the first report showing better outcomes of one technique over the other.

We present two patients with bothersome stress urinary incontinence (SUI) following radical hysterectomy and pelvic lymphadenectomy for early stage cervical cancer. One patient underwent adjuvant radiotherapy. We selected, after extensive counseling, TVT-Secur in these two patients as we aimed to avoid the pelvic cavity, expecting altered anatomy due to major pelvic surgery, and counting on low risk of developing bladder retention, given results of a case series. Both patients were continent post-operatively. One patient presented with a small tape erosion that was successfully corrected using local analgesics. The other patient developed urgency symptoms that disappeared after treatment with solifenacine. Both patients had detrusor hypo-activity at pre-operative urodynamics, but no bladder retention occurred following surgery. In patients with a history of radical hysterectomy who present with SUI, we would advise to counsel that satisfying results can be expected of TVT-Secur, although it is likely that additional care after surgery is needed.

Resumen Objetivos El objetivo de esta publicacion es describir la tecnica quirurgica, evaluar las complicaciones y los resultados a corto plazo de las cintas TVT secur y MiniArc. Material y Metodo entre Octubre de 2006 y Agosto 2007 se realizo correccion quirurgica con TVT SecurTM, Women’s Health & Urology, Ethicon, Johnson & Johnson, colocando la cinta en forma de hamaca, a 51 pacientes,38 de ellas con incontinencia de esfuerzo pura y 13 con incontinencia mixta y con una edad media de 57anos.Entre Septiembre 2007 y Febrero de 2008 se intervino con cinta AMS MiniarcTM swing system, colocada en hamaca, a 41 pacientes, 33 pacientes con incontinencia de esfuerzo pura y 8 con incontinencia mixta, con un edad media de 58 anos. Todos los procedimientos se realizan con sedoanalgesia y en regimen de Cirugia Mayor Ambulatoria. Las pacientes fueron controladas en consultas externas al mes, 3 meses y al ano. Se les realizo historia clinica y cuestionario ICIQ- SF al que le anadimos una pregunta para cuantificar el grado de satisfaccion, asi como exploracion fisica. Comparamos los resultados de ambas tecnicas y realizamos estudio estadistico mediante test de Student. [Analisis con el programa informatico SPSS (V14.0)]. Resultados La mediana de seguimiento en el grupo TVT secur fue de 328 dias (rango 163-522 dias) y en el grupo MiniArc de 101 dias (rango 41-209 dias). De las 92 paciente intervenidas, 51 con TVT secur y 41 con MiniArc solo registramos una complicacion quirurgica con TVT secur que fue una perforacion vesical. Considerando como curacion objetiva que la paciente en la exploracion fisica realizada en consulta con vejiga llena presente un test de esfuerzo negativo. En el grupo TVT secur el 80,4% de las pacientes estan curadas y en el grupo de MiniArc el 90,2% no existiendo diferencias significativas entre ambos grupos( p 0,095). Para evaluar la curacion subjetiva utilizamos el test ICIQ-SF y la pregunta de satisfaccion y observamos como, en el control al mes y tercer mes no existen diferencias significativas, estando el 90% de las pacientes satisfechas. En el control anual, solo realizado en el grupo TVT secur, el 80 % de las pacientes se encuentran muy satisfechas. Conclusion Estas nuevas cintas presentan un numero menor de complicaciones permiten la posibilidad de colocacion con anestesia local pero todavia son necesarios estudios aleatorizados con un mayor seguimiento.

Objetivos: El objetivo de esta publicación es describir la técnica quirúrgica, evaluar las complicaciones y los resultados a corto plazo de las cintas TVT secur y MiniArc. Material y Método: entre Octubre de 2006 y Agosto 2007 se realizó corrección quirúrgica con TVT SecurTM, Women’s Health & Urology, Ethicon, Johnson & Johnson, colocando la cinta en forma de hamaca, a 51 pacientes,38 de ellas con incontinencia de esfuerzo pura y 13 con incontinencia mixta y con una edad media de 57 años. Entre Septiembre 2007 y Febrero de 2008 se intervino con cinta AMS MiniarcTM swing system, colocada en hamaca, a 41 pacientes, 33 pacientes con incontinencia de esfuerzo pura y 8 con incontinencia mixta, con un edad media de 58 años. Todos los procedimientos se realizan con sedoanalgesia y en régimen de Cirugía Mayor Ambulatoria. Las pacientes fueron controladas en consultas externas al mes, 3 meses y al año. Se les realizó historia clínica y cuestionario ICIQ- SF al que le añadimos una pregunta para cuantificar el grado de satisfacción, así como exploración física. Comparamos los resultados de ambas técnicas y realizamos estudio estadístico mediante test de Student. [Análisis con el programa informático SPSS (V14.0)]. Resultados: La mediana de seguimiento en el grupo TVT secur fue de 328 días (rango 163-522 días) y en el grupo MiniArc de 101 días (rango 41-209 días). De las 92 paciente intervenidas, 51 con TVT secur y 41 con MiniArc solo registramos una complicación quirúrgica con TVT secur que fue una perforación vesical. Considerando como curación objetiva que la paciente en la exploración física realizada en consulta con vejiga llena presente un test de esfuerzo negativo. En el grupo TVT secur el 80,4% de las pacientes están curadas y en el grupo de MiniArc el 90,2% no existiendo diferencias significativas entre ambos grupos (p 0,095). Para evaluar la curación subjetiva utilizamos el test ICIQ-SF y la pregunta de satisfacción y observamos como, en el control al mes y tercer mes no existen diferencias significativas, estando el 90% de las pacientes satisfechas. En el control anual, sólo realizado en el grupo TVT secur, el 80 % de las pacientes se encuentran muy satisfechas. Conclusión: Estas nuevas cintas presentan un número menor de complicaciones permiten la posibilidad de colocación con anestesia local pero todavía son necesarios estudios aleatorizados con un mayor seguimiento. Background: The purpose of this publication is to describe the surgical technique, assess complications and short-term results of TVT secur and MiniArc tapes. Materials and Methods: From October 2006 to August 2007 it was carried out the surgical correction with TVT SecurTM, Women’s Health & Urology, Ethicon, Johnson & Johnson, placing the tape as a hammock, to 51 patients, 38 of them with pure stress incontinence and 13 with mixed incontinence and with an average age of 57 years. From September 2007 to February 2008 41 patients, 33 of them with pure stress incontinence and 8 with mixed incontinence, with an average of age of 58 years were operated with AMS MiniarcTM swing system tape, posted on hammock. All procedures were performed with sedoanalgesia and Ambulatory Surgery regime. Patients were monitored in outpatient visits one month, 3 months and one year after surgical procedure. Medical history and questionnaire and ICIQ-SF, to which we added a question to quantify the degree of satisfaction, as well as physical examination, were done. We compared the results of both technical procedures and statistical survey was conducted by Student test. [Analysis with SPSS software (V14.0)]. Results: The median follow-up in TVT secur group was 328 days (range 163-522 days) and 101 days (range 41-209 days) in the MiniArc group. We only had one (TVT secur group) surgical complication in all the series (92 patients) being a bladder perforation. Taking into account that we read a negative test effort as an objective cure in the TVT secur group, 80.4% patients are cured and 90.2% in the MiniArc group without significant difference between both groups (p 0095). To assess the subjective healing we utilized the ICIQ-SF test and the satisfaction extra-question and we noted that there is no significant difference between the first and third month controls. (90% of patients satisfied). 80% of patients were completely satisfied in the first year control that was only performed to TVT secur group. Conclusion: These new tapes show fewer complications that the TVT-O and TOT tapes and allow the possibility of placement with local anesthesia but further studies are needed.

Single-incision slings are now approved by the US Food and Drug Administration. TVT Secur (Ethicon, Somerville, NJ), the first mini sling available for use, offers a minimally invasive approach to the surgical treatment of stress incontinence, with its greatest benefit being reduced patient discomfort in the immediate postoperative period. Although little data are available regarding the safety and efficacy of this new generation of slings, TVT Secur appears to be relatively safe. Long-term efficacy has not yet been determined, but short-term efficacy rates seem to compare with traditional midurethral mesh slings. Long-term follow-up is warranted and comparative studies are needed to determine its true efficacy.

Resumen Objetivo Revisar nuestra experiencia inicial en la correccion de la incontinencia de orina de esfuerzo, con el nuevo sistema TVT-Secur. Revisar la efectividad y seguridad de esta tecnica Metodo Entre enero y mayo del 2007, se realizaron 16 TVT-Secur (Women’s Health & Urology, Ethicon, Johnson & Johnson) a pacientes de la Unidad de Uroginecologia y Cirugia Vaginal, del Departamento de Ginecologia y Obstetricia de la Clinica Las Condes. En 6 pacientes la cinta se situo en “V” y en 10 en “U”. La mediana de edad para el grupo fue de 52 anos, indice de masa corporal 29, paridad 3. En todas se realizo estudio urodinamico previo como parte del estudio y seleccion preoperatoria. Todas debian tener al menos un ano de incontinencia de orina de esfuerzo, y ninguna debia tener correccion quirurgica previa Resultado La mediana de tiempo operatorio fue de 10 minutos, con un rango entre 8 y 15 minutos. No se presentaron complicaciones durante el acto operatorio, ni en el postoperatorio inmediato, temprano y tardio. La EVA registrada a las 12 horas fue de 1 a 2. Se obtuvo correccion de la incontinencia de orina de esfuerzo en todas las pacientes. El tiempo de seguimiento fue entre 1 y 4 meses, con una mediana de 2 meses. Todas expresaron estar conformes con los resultados de la cirugia y la recomendarian a otras pacientes en igual situacion Conclusiones Segun nuestra experiencia inicial, el nuevo sistema TVT-Secur, aparece como eficaz y seguro, en la quirurgica de la incontinencia de orina de esfuerzo. Sin embargo, solo el seguimiento a largo plazo, y la incorporacion de nuevos pacientes al estudio, permitira determinar el mantenimiento de estos buenos resultados en el tiempo

Various perioperative and postoperative complications have been reported after the use of pubo-vaginal tension-free vaginal tapes. The transobturator approach was introduced to minimize the potential complications connected with entering the retropubic space, but different types of complications have also been described. The next generation of recently introduced minitapes such as TVT-Secur is intended to minimize the incidence of complications. This report concerns a patient who underwent a tension-free vaginal tape procedure-TVT-Secur hammock approach-and developed severe bleeding from the internal obturator muscle, which required surgical intervention.

Dear Editor,Recently, Larsson et al. [1] reported a case bleeding fromcorona mortis during tension-free vaginal tape (TVT)-Securprocedure. As is stated in their article, the tape at the leftside was correctly placed at the second attempt. After thesurgery, early laparotomy was performed due to suspicionof haemorrhage—which was confirmed, and the bleedingcorona mortis was ligated.Our team performed several cadaver studies in order todescribe possible complications that might occur duringnew methods for treatment of stress urinary incontinence.One of the methods evaluated is TVT-S in the U position.We have witnessed and well documented two cases of verynear proximity (could be described as almost direct contact)of the TVT-S inserter and the vessels communicatingbetween obturator vessels and external iliac or deepepigastric vessels.The first contact we witnessed in the group forevaluation of TVT-S in the U position that consists of 19formalin-embalmed bodies. Due to the rigidity of theformalin-embalmed bodies, the legs needed to be placedin 30° flexion in the hip joint and in 30° abduction in thehip joint. For that reason, we have also included a group offresh frozen bodies, where the legs were positioned asrecommended in standard procedure. In this group of sixbodies, we have witnessed also one contact with the coronamortis after placing TVT-S in the U position.As can be seen on the attached pictures, the near contactwith the corona mortis is well shown and it would be amatter of fortune if those vessels will start bleeding aftertouching them with a scalpel-shaped inserter.We assume that the injury of the corona mortis describedby Larsson and colleagues [1] happened during the firstattempt to place the TVT-S and it seems to us that the firstattempt was made more upwards similar to the TVT-S inthe U position.For the first time, we thought that the direct contact withthe corona mortis does not have to lead towards injury ofthe aforementioned corona mortis and that the correlationwith the cadaver study to the live surgery might be difficult;still, the description of the injury witnessed by Larsson ismore than clear proof that cadaver study might showpossible complications occurring during a normal urogyne-cological surgery.

TVT-Secur is a new "less" invasive derivative of the tension-free vaginal tape (TVT). We report an unusual case of dyspareunia for both the patient and her husband resulting from a retained finger pad from the TVT-Secur introducer. The sling was also explanted because of malposition.