Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O.

The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.

Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: a multicenter, randomized study.

PURPOSE: We evaluated the efficacy of the Pelvicol porcine collagen implant for preventing recurrent anterior vaginal wall prolapse in women undergoing primary surgery for pelvic organ prolapse. MATERIALS AND METHODS: This was a prospective, randomized, multicenter trial in 206 women with stage II or greater anterior vaginal wall prolapse (point Ba -1 or greater) according to the pelvic organ prolapse quantification system. The patients were randomly assigned to undergo anterior vaginal repair or the same procedure with Pelvicol implant reinforcement. SPSS software was used for data analysis. RESULTS: A total of 201 women were available for surgical outcome analysis, including 98 and 103 in the implant and no implant groups, respectively. All completed the 1-year followup visit. Most women were satisfied with the postoperative condition with a significant decrease in the visual analog scale score in each group (p <0.001). Anatomical anterior recurrence (point Ba greater than -1) was observed in 7 women (7%) in the implant group and in 20 (19%) in the other groups (OR 3.13, 95% CI 1.26-7.78, p = 0.019). Additionally, there were 11 women (3 and 8, respectively, or 5%) with posterior recurrence and 6 (3 per group or 3%) with unsatisfactory results at the upper vaginal segment. One patient who received a porcine implant had vaginal extrusion of the mesh 1 month after surgery. CONCLUSIONS: Our data show that the Pelvicol implant can be easily and readily used to augment and reinforce anterior colporrhaphy. The prolapse recurrence rate was considerably lower in the implant group compared with outcomes in patients treated with simple anterior repair.

Tension-free vaginal tape (TVT) and intravaginal slingplasty (IVS) for stress urinary incontinence: a multicenter randomized trial.

OBJECTIVE: This study was undertaken to compare the efficacy and morbidity of 2 minimally invasive procedures for stress urinary incontinence. STUDY DESIGN: This was a prospective randomized multicenter trial; 190 women with primary urodynamic stress incontinence were randomly assigned to tension-free vaginal tape (TVT) (n = 95) or intravaginal slingplasty (IVS) (n = 95). The primary and secondary outcome measures were rates of success and complications. SPSS software was used for data analysis. RESULTS: At 2 years 92 and 87 patients were available in the TVT and IVS group for outcomes analysis. Subjectively, 80 (87%) and 68 (78%) women were cured, respectively. Objectively, a 1-hour pad test was negative in 78 (85%) and 63 (72%) patients. Eight of the patients assigned to IVS (9%) had vaginal erosion/infection, compared with none in the TVT group (P < .01). CONCLUSION: Both procedures were effective for stress incontinence, but 9% of women treated with the IVS required removal of the tape for erosions.