TORONTO—A modified inside-out transobturator (TVT-O) procedure is safe and effective for treating stress urinary incontinence (SUI) in women, according to data presented at the joint annual meeting of the International Continence Society and the International Urogynecological Association.
The new procedure involves a tape that is shortened to 12 cm long. It also requires less dissection than the original TVT-O approach because the obturator membrane does not need to be perforated with the surgeon’s scissors or guide. The results of a randomized study indicate that it produces a similar SUI cure rate at one year as the original procedure and is associated with significantly reduced immediate postoperative pain.
In the single-center study, lead investigator Jean de Leval, MD, PhD, from the Department of Urology at the University of Liege in Belgium, and his colleagues randomized 87 women with SUI to the original TVT-O procedure and another 88 to the modified procedure. Enrollemnt took place between January 2007 and December 2008. The women who were included did not have pelvic organ prolapse requiring surgical treatment, detrusor overactivity, an active urinary or vaginal infection, neurogenic bladder, a post-void residual volume of 100 ml or more, or contraindications to surgery.
Eight-four and 86 patients in the two groups, respectively, completed the one-year follow-up and thus were included in the data analysis. The patients in the two groups had similar baseline characteristics. Patients in both groups had no perioperative complications. One case of postoperative urinary retention occurred in each group and one vaginal erosion was observed in the original TVT-O group.
SUI symptoms disappeared in 91.7% of patients who underwent the original TVT-O procedure and 90.7% of those who had the modified procedure, Pr. D. Waltregny, Head of the Department of Urology from the University of Liege and co-investigator of the study, reported. The proportion of patients who experienced improvement or no change of SUI symptoms were similar in both groups. Furthermore, the two groups had similar postoperative rates of urgency, frequency and dysuria.
After the surgery was completed, 65.9% of patients in the original TVT-O group experienced groin pain compared with 42% in the modified TVT-O group. The next day, patients in the modified TVT-O group had also a significantly lower rate of groin pain than those who had the original procedure (39.8% vs. 59.1%). The investigators also found that the severity of the immediate post-operative pain was approximately 50% lower with the modified TVT-O procedure. No patient complained of long term groin pain in either group.
Commenting on Dr. Waltregny’s presentation, Christian Saussine, MD, PhD, told Renal & Urology News that the design of the new sling appears to be sound and the results are compelling. “It results in solid fixing of the tape in patients’ tissue, and less post-operative pain,” said Dr. Saussince, Professor of Urology at the University of Strasbourg in Strasbourg, France. “Now the results need to be replicated by other groups.”
The product, called TVT-ABBREVO (Ethicon Women’s Health and Urology), was scheduled to be launched in Europe on September 15 and in North America on September 30.