Efficacy analysis of trans-obturator tension-free vaginal tape (TVT-O) plus modified Ingelman-Sundberg procedure versus TVT-O alone in the treatment of mixed urinary incontinence: a randomized study.

OBJECTIVE: The treatment of women with mixed urinary incontinence still poses a great challenge. This study evaluated surgical outcomes of combined trans-obturator tension-free vaginal tape (TVT-O) and modified Ingelman-Sundberg (IS) procedure for the treatment of mixed urinary incontinence.

METHODS: A randomized controlled trial was conducted. Ninety-six women diagnosed with mixed incontinence were randomized, with 49 allocated to TVT-O plus IS and 47 to TVT-O alone. A baseline urodynamic study and evaluation of quality of life (QOL) was conducted. The primary outcome measure was objective assessment of surgical outcomes, and the secondary outcome measure was warning time.

RESULTS: Objective surgical response rate was significantly higher in the TVT-O plus IS group than in the TVT-O alone group (84.8% vs. 62.8%; p=0.019). Furthermore, a significant increase in warning time was observed in the TVT-O plus IS group (from 3.9 to 9.4 min; p=0.006), but the increase in warning time within the TVT-O alone group was not statistically significant (from 4.3 to 4.5 min; p=0.695). Postoperative complications were similar in the two study groups with respect to pelvic hematoma, nerve injury, sepsis, mesh erosion, and fistula formation. However, fever occurred more frequently in the TVT-O plus IS group (30.4% vs. 20.9%; p=0.026).

CONCLUSIONS: Mixed urinary incontinence can potentially be treated with a one-step combined surgery using trans-obturator sling plus modified IS procedure. Although surgical time and blood loss were significantly increased in the TVT-O plus IS group, overall morbidity was not significantly increased.