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Randomized Controlled Trial
. 2012 Jan-Feb;18(1):41-5.
doi: 10.1097/SPV.0b013e31823bdbcf.

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures

Lekha S Hota  1 , Katherine Hanaway, Michele R Hacker, Anthony Disciullo, Eman Elkadry, Patricia Dramitinos, Alexander Shapiro, Tanaz Ferzandi, Peter L Rosenblatt
Affiliations
Randomized Controlled Trial

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures

Lekha S Hota et al. Female Pelvic Med Reconstr Surg. 2012 Jan-Feb.

Abstract

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.

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References

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