A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results

作者：Palva Kirsi; Rinne Kirsi; Aukee Pauliina; Kivela Aarre; Laurikainen Eija; Takala Teuvo; Valpas Antti; Nilsson Carl Gustaf^*

来源：International Urogynecology Journal and Pelvic Floor Dysfunction, 2010, 21(9): 1049-1055.

DOI：10.1007/s00192-010-1160-y

• Stress urinary incontinence
• Tension-free
• vaginal tape
• Tension-free
• Transobturator vaginal tape

This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate.
Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires.
At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups.
The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

• 出版日期2010-9