Long-term results of a prospective randomized trial comparing tension-free vaginal tape versus transobturator tape in stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: This study was aimed at investigating the long-term effectiveness of minimally invasive mid-urethral sling (MUS) surgery and at comparing the outcomes between retropubic (tension-free vaginal tape, TVT) and transobturator tape (TOT) methods in the treatment of stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) with a predominant stress component in a long-term follow-up of a randomized controlled trial. METHODS: This work is a long-term follow-up study of a previous prospective randomized trial conducted in the Department of Obstetrics and Gynecology at Oulu University Hospital between January 2004 and November 2006. The original 100 patients were randomized into the TVT (n=50) or TOT (n=50) group. The median follow-up time was 16 years, and the subjective outcomes were evaluated using internationally standardized and validated questionnaires. RESULTS: Long-term follow-up data were obtained from 34 TVT patients and 38 TOT patients. At 16 years after MUS surgery, the UISS significantly decreased from a preoperative score in the TVT (11.88 vs 5.00, p<0.001) and TOT (11.05 vs 4.95, p<0.001) groups, showing a good long-term success of the MUS surgery in both groups. In comparing the TVT and TOT procedures, the subjective cure rates did not differ significantly between the study groups in long-term follow-up according to validated questionnaires. CONCLUSION: Midurethral sling surgery had good long-term outcomes in the treatment of SUI and MUI with a predominant stress component. The subjective outcomes of the TVT and TOT procedures were similar after a 16-year follow-up.

Posterior Transvaginal Mesh without Concurrent Surgery: How Does It have an Effect on the Untreated Vaginal Compartment?

BACKGROUND/AIMS: To report objective and subjective outcomes and adverse events after placement of Elevate® Posterior transvaginal mesh without concurrent surgery. Changes in non-affected anterior compartment were under special interest. METHODS: A prospective study of Elevate® Posterior procedure in patients with symptomatic posterior compartment prolapse. Pelvic organ prolapse (POP) quantification (POP-Q) measurements and Pelvic Floor Dysfunction Inventory-20 (PFDI-20) and POP/urinary Incontinence Sexual Questionnaire (PISQ-12) questionnaires were used. Primary outcome was the incidence of de novo anterior prolapse. Secondary outcomes were complication rate and posterior compartment objective and subjective cure. RESULTS: A total of 111 women underwent an Elevate® Posterior mesh procedure and 109 attended a control visit at 3 months. De novo anterior prolapse emerged in 3.2-15% of the women, depending on the definition. Posterior POP-Q stage ≤I was obtained in 92 (84%) women and leading edge at or above the hymen in 107 (98%) women. Bulge symptoms disappeared in 86% of the cases. One (0.9%) mesh exposure was detected. Reoperation rate was 2.8, and 3.7% patients experienced postoperative pain. PFDI-20 and PISQ-12 scores improved significantly. CONCLUSIONS: A trend of de novo prolapse formation in the non-affected vaginal compartment is observed. The Elevate® Posterior method is effective in terms of both objective and subjective outcomes. According to our results, the mesh exposure rate is low.

A prospective randomized trial comparing tension-free vaginal tape versus transobturator tape in patients with stress or mixed urinary incontinence: subjective cure rate and satisfaction in median follow-up of 46 months.

OBJECTIVE: The aim of this study was to investigate the difference in subjective cure rate and patient satisfaction between tension-free vaginal tape (TVT) and transobturator tape (TOT) surgical methods in the treatment of stress and mixed urinary incontinence. MATERIAL AND METHODS: From January 2004 to November 2006, a total of 100 patients suffering from stress or mixed urinary incontinence and evaluated to benefit from operative treatment were randomized to undergo either TVT or TOT surgery in Oulu University Hospital. There were no significant differences between the study groups concerning the patient characteristics. During the 3, 14 and 46 month follow-up steps, information on subjective cure and patient satisfaction was gathered with Urinary Incontinence Severity Score and Detrusor Instability Score questionnaires and a specific question about satisfaction. RESULTS: The subjective cure rate was 81% in both study groups. The satisfaction rate was 79% in the TVT group and 74% in the TOT group at the final follow-up. Urge symptoms were relieved in 70% of patients in the mixed urinary incontinence subgroup. De novo urgency occurred in 17% of the patients in the stress urinary incontinence subgroup, and 45% of these patients were unsatisfied after the follow-up. CONCLUSIONS: TVT and TOT are equally effective methods in the treatment of urinary incontinence and patient satisfaction is similar in both methods. A large proportion of patients with mixed urinary incontinence found the operation beneficial for urge symptoms.

Posterior Intravaginal Slingplasty versus Unilateral Sacrospinous Ligament Fixation in Treatment of Vaginal Vault Prolapse.

Objective. To investigate the differences in efficacy, postoperative complications, and patient satisfaction between posterior intravaginal slingplasty (PIVS) and unilateral sacrospinous ligament fixation (SSLF) procedures. Study Design. A retrospective study of thirty-three women who underwent PIVS or SSLF treatment for vaginal vault prolapse in Oulu University Hospital. The patients were invited to a follow-up visit to evaluate the objective and subjective outcomes. Median follow-up time was 16 months (range 6-52). The anatomical outcome was detected by the Pelvic Organ Prolapse Quantification (POP-Q) system. Information on urinary, bowel, and sexual dysfunctions and overall satisfaction was gathered with specific questionnaire. The data were analyzed using Mann-Whitney U test and Fisher's exact test. Results. Mesh erosion was found in 4 (25%) patients in the PIVS group. Anatomical stage II prolapse or worse (any POP-Q point ≥-1) was detected in 8 (50%) patients in the PIVS group and 9 (53%) patients in the SSLF group. Overall satisfaction rates were 62% and 76%, respectively. Conclusion. The efficacy of PIVS and SSLF is equally poor, and the rate of vaginal erosion is intolerably high with the PIVS method. Based on our study, we cannot recommend the usage of either technique in operative treatment of vaginal vault prolapse.

Intravaginal slingplasty sling is associated with increased risk of vaginal erosion.

OBJECTIVE: Two structurally different polypropylene tapes are used in tension-free vaginal tape (TVT) and intravaginal slingplasty sling (IVS) procedures for the treatment of female stress urinary incontinence. This study aimed to compare TVT and IVS operations for late postoperative complications, especially vaginal erosion. DESIGN: A retrospective study. SETTING: Oulu University Hospital, Finland. SAMPLE: The study sample was constituted by 373 patients operatively treated for female urinary incontinence between January 2000 and June 2004. A total of 293 patients underwent the TVT operation and 80 patients the IVS operation. METHODS: We analyzed the data using Fisher's Exact test, Pearson's chi-squared test, and log linear test. For categorical variables we used risk ratios with 95% confidence intervals. MAIN OUTCOME MEASURES: The incidence of late complications, especially vaginal erosion. RESULTS: Symptomatic erosion (p < 0.001; risk ratio 13.7; 95% confidence interval 4.03-46.8) was seen in 3 patients (1%) in the TVT group and in 13 patients (16%) in the IVS group. The median time to the onset of symptoms was 9 and 12 months in these groups, respectively. CONCLUSIONS: We suggest that the high vaginal erosion rate in the IVS group is associated with the tape material.