Fixation of the Ajust minisling based upon cadaveric study.

INTRODUCTION AND HYPOTHESIS: The objective was to describe the fixation site of the anchor of the Ajust mid-urethral minisling. METHODS: This cadaveric study was based on a group of 11 formalin-embalmed bodies with legs positioned in 30° flexion and 30° abduction, and a group of five fresh-frozen bodies with legs positioned as normal during the procedure. The groups were later compared. The fixation site was dissected and described. The distance to the obturator bundle was considered as the primary safety parameter. To compare the groups of fresh-frozen bodies and formalin-embalmed bodies, the Student's t test and Mann-Whitney test were used. RESULTS: In the group of formalin-embalmed bodies the mean distance from the anchoring device to the obturator nerve was 4.23 cm. In 19 cases out of 22 the anchor was within the complex of the obturator membrane and obturator muscles. In the group of fresh frozen bodies the mean distance to the obturator nerve was 3.15 cm. In 9 cases out of 10 the anchor was in the complex of the obturator membrane and obturator muscles. CONCLUSION: The distance from the anchor to the obturator nerve was more than 2 cm in all cases. Correct placement in the obturator membrane was achieved in 65.6 % of cases. In 87.5 % of cases the anchor was placed within the complex of obturator membrane and obturator muscles.

Women's quality of life and sexual function after transvaginal anterior repair with mesh insertion.

OBJECTIVE: Current evidence about the impact of pelvic floor surgery on sexual function is conflicting. Only a few studies have reported with validated questionnaires on sexual function after transvaginal mesh repair, with a discrepancy in reported outcomes. The aim of this study was to prospectively explore the impact of anterior repair (AR) with mesh insertion on sexual function, quality of life and dyspareunia. STUDY DESIGN: 69 women with symptomatic stage II or greater prolapse exclusively of the anterior compartment participated in a prospective study on safety and efficacy of two mesh implantation techniques for anterior vaginal wall prolapse repair between September 2007 and May 2009. They were invited to complete the validated condition-specific short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and quality of life (QoL) questionnaires (Pelvic Organ Prolapse (POP) Distress Inventory (POPDI), Urinary Distress Inventory (UDI), POP Impact Questionnaire (POPIQ), and Urinary Impact Questionnaire (UIQ)) pre-operatively and 6 months post-operatively. All data were processed and analyzed in Statistical Computing Environment R, version 2.9.1. RESULTS: A significant decrease of Qol scores and a significant increase of PISQ-12 scores occurred after surgery. All sexually active women resumed sexual activity postoperatively. The majority of non-sexually active women remained sexually inactive. Postoperatively the frequency of pain during intercourse increased in 31% of cases and decreased or stayed unchanged in 69% of cases. The incidence of de novo dyspareunia after mesh repair was 4% while the incidence of dyspareunia slightly increased from 25% to 29% postoperatively. CONCLUSIONS: The results of this study suggest no deterioration in sexual function, a significant improvement in quality of life and a low incidence of de novo dyspareunia six months after AR with mesh insertion. Despite these findings, the majority of non-sexually active women remain sexually inactive postoperatively. These conclusions should be confirmed in a longer follow-up.

Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.

INTRODUCTION AND HYPOTHESIS: 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). METHODS: 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. RESULTS: 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 < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02). CONCLUSIONS: Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.

Ultrasound appearances after mesh implantation--evidence of mesh contraction or folding?

INTRODUCTION AND HYPOTHESIS: Polypropylene meshes are frequently used in abdominal and vaginal reconstructive surgery. Recently, several authors have claimed that mesh-associated complications may be linked to mesh shrinkage. We have performed a prospective study with postoperative follow-up by ultrasound examination at two time points after Prolift anterior implantation to assess changes in the ultrasound appearance of mesh implants over time. METHODS: We assessed 36 patients who had undergone mesh implantation with Prolift anterior mesh for the correction of symptomatic anterior vaginal wall prolapse. During the surgery, we measured the actual midline length of the mesh (initial length). On the fourth postoperative day, we performed a vaginal ultrasound examination (US) to measure mesh length in the midsagittal plane. A second US was performed 3-5 months after surgery to repeat this measurement. RESULTS: There was a significant difference in mesh length determined before and 4 days after surgery (90.3 vs. 57.1 mm, P = <0.0001) indicating intraoperative folding. On comparing early and late postoperative ultrasound measurements, there was a reduction in length from 57.1 to 48.3 mm (P < 0.0001), indicating possible shrinkage or retraction. CONCLUSIONS: Intraoperative folding seems to be responsible for a large part of the difference between preoperative (in vitro) and postoperative (US) measurements of mesh dimensions, suggesting that surgical techniques may require adjustment.

Correlation between changes in ultrasound measurements and clinical curative effect of tension-free vaginal tape-SECUR* procedure.

INTRODUCTION AND HYPOTHESIS: The hypotheses of this study were that the TVT-SECUR procedure restricts urethral mobility, which leads to a greater likelihood of curative effect, and that the restriction might change over time. METHODS: Analyses of the position of the urethra and the tape of 85 patients who underwent the TVT-S procedure were performed using perineal ultrasonography. The efficacy of the TVT-S procedure was evaluated by cough test and by the questionnaire ICIQ-UI SF. RESULTS: Objectively, 53/85 (62%) of patients had a negative cough test, and in 32/85 (38%) of patients leakage of urine persisted. The TVT-S procedure restricts urethral mobility, and a higher degree of obstruction is associated with a higher likelihood of cure. The restriction weakens within the first 3 months after surgery. CONCLUSIONS: The objective cure rate of TVT-S procedure is low irrespective of placement technique. This may be due to insufficient restriction of urethral mobility.

Initial experience with a short, tension-free vaginal tape (the tension-free vaginal tape secur system).

OBJECTIVE: The aim of this study is to present our first experience with a novel modification of the tension-free sling idea and to evaluate the safety and efficacy of this new procedure for the treatment of stress urinary incontinence in women. STUDY DESIGN: Eighty-five women with previously untreated stress urinary incontinence were recruited to participate in a clinical study. The efficacy of this surgical procedure was evaluated perioperatively and 3 months (+/-1 week) after operation--objectively by cough test and subjectively by the questionnaires Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire and the International Consultation on Incontinence Questionnaire-Short Form. All data were processed and statistical analyses performed in statistical environment R, version 2.5.1. RESULTS: From our results we conclude that there were no perioperative complications, objectively 62% of these patients were completely dry and 25% of patients improved. We observed a higher proportion of vaginal wall erosion (7/85) and urgency de novo (5/85) in the learning period group with respect to the routine period group. CONCLUSIONS: Our first experience with the tension-free vaginal tape secur system procedure is that it has a low percentage of perioperative complications. The learning curve has to be taken in account with reference to postoperative complications.

[The solution of stress urinary incontinence in women by the TVT-S surgical method--correlation between the curative effect of this method and changes in ultrasound findings]. / Resení stresové inkontinence moci u zen operacní medotou TVT-S--vztah mezi lécebným efektem operacní metody a zmenami hodnot ultrazvukových parametru.

OBJECTIVE: The aims of this study were to compare ultrasonographic findings of the urethra and the tape position and mobility following the tension-free vaginal tape secure system (TVT-S) procedure and to correlate these data with clinical signs of cure and failure of this procedure in the treatment of stress urinary incontinence (SUI) in women. Another aim of our study was to determine indications for particular position of the tape (the "hammock" or "U" position) based on ultrasonographic findings of the urethra and the tape position following TVT-S. DESIGN: Prospective, randomized study. SETTINGS: Department of Gynecology and Obstetrics, First faculty of Medicine, Charles University and General Teaching Hospital, Prague. MATERIALS AND METHODS: Analyses of the position of the urethra and the tape of 85 patients were performed using perineal ultrasonography. The efficacy of the TVT-S procedure was evaluated by cough test and by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF). RESULTS: Objective assessment by cough test showed that 53 (62%) of our patients were completely dry, and in 32 (38%) patients leakage of urine persisted after the operation. From the US examination and results we can conclude that 3 months after the operation the mobility of the urethra and bladder neck are restricted. A correlation between cure effect and the restriction of the movement of the urethra was found between the position at the middle of the urethra before and after the operation. Subjective assessment of the cure effect of this operation by the ICIQ-UI SF questionnaires (n=81) showed that 39 (48%) of our patients were completely dry and 24 (30%) of patients improved, which means that in 42 (52%) patients leakage of urine persists after the operation. There are differences in the restriction of urethral mobility between the cured patients and those where leakage persisted. The middle of the urethra and UVJ are more restricted in movement in cured patients. We found no statistically significant differences between the US measurements of the position of the urethra of patients with the tape in the "hammock" and the "U" position. The only statistically significant difference found is a slightly higher tension of the "U" tape three months after the operation during the Valsalva maneuver; the median width of the tape in the "hammock" position is 10.1 mm, while in the "U" position it is 8.1 (Wilcoxon test p = 0.0056). There were six patients diagnosed with urgency de novo, without urge incontinence in this series. In seven cases we found vaginal erosion. CONCLUSIONS: From the US examination and results we can conclude that after the TVT-S operation, mobility of the urethra and bladder neck is restricted. After comparing ultrasonographic findings of the urethra and the tape position following TVT- Secure we can determine that there is no certain indication for placement of the tape in the "hammock" or the "U" position. The cure effect for different positions of the tape is similar. In some respects the slightly higher tension of the tape in the "U" position suggests that this tape position may be preferred in patients with intrinsic sphincter defect (ISD) of the urethra. A comparison of the cure effect of the TVT-S procedure with other tape procedures suggests a lower cure effect of this operation.