Objectives: This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).
Methods: This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year.
Results: Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3–16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5–128.0) at 12 weeks and 3.5 (95% CI, 1.1–11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36).
Conclusions: The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.
TVT-S appears to have a higher risk of a positive post-operative cough stress test compared to TVT-O, however results indicate similar improvement in quality of life and symptoms.
From the *Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge; †Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Boston; ‡Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston; and §Department of Epidemiology, Harvard School of Public Health, Boston, MA.
Reprints: Lekha S. Hota, MD, 725 Concord Ave, Suite 1200, Cambridge, MA 02138. E-mail: email@example.com.
This work was conducted with support from Harvard Catalyst, The Harvard Clinical and Translational Science Center (National Institutes of Health Award no. UL1 RR 025758 and financial contributions from Harvard University and its affiliated academic health care centers).
Financial support for this study was obtained from Ethicon Women’s Health & Urology, a division of Ethicon, Inc, a Johnson & Johnson Company, as an investigator-initiated study.
The authors declare that they have nothing to disclose.