Quality of Life After Tension-Free Vaginal Tape Obturator
Abstract & Commentary
By Frank W. Ling, MD, Clinical Professor, Dept. of Obstetrics and Gynecology, Vanderbilt University School of Medicine, Nashville, is Associate Editor for OB/GYN Clinical Alert.
Dr. Ling reports no financial relationship to this field of study.
Synopsis: Follow-up of 100 women 12 months after they underwent TVT-O demonstrated that it was comparable to the traditional Burch colposuspension as well as the retropubic TVT procedures.
Source: Lim JL, et al. Clinical and quality-of-life outcomes in women treated by the TVT-O procedure. BJOG. 2006;113:1315-1320.
The purported advantages of the tension-free vaginal tape obturator (TVT-O) procedure include avoidance of bowel damage, reduction in risk of bladder and major vessel damage, and elimination of the need for routine cystoscopic evaluation during insertion. These Australian investigators at a tertiary care urogynecologic center prospectively evaluated stress test success rates at 6 months, but also looked for subjective issues at 6 and 12 months. Urodynamic testing was done on all 100 patients. They were able to follow patients for a mean duration of 18.5 months.
At 6 months, the negative stress test rate was 95%. The patients' subjective success rates at 6 and 12 months follow-up were 92% and 84% respectively. De novo urge incontinence occurred in 4.1% at 6 months and 4.8% at 12 months. Quality-of-life improvement was noted and patient satisfaction was 77% and 67% at 6 and 12 months. Complications included 6 recurrent UTI's, 2 patients with voiding difficulty, 3 cases of groin discomfort, and one each of tape erosion, urethral irritation, wound infection and hematoma.
The authors conclude that the TVT-O is both safe and effective in the treatment of female stress incontinence.
Does this study apply to you? Maybe it does, maybe it doesn't. There are some very good things about this article. The 100 cases is a large number. It was done in a single setting. All patients were documented to have stress incontinence preoperatively. The study design was prospective. The follow-up was reasonable, but not perfect. That brings me to some potential concerns that might make the reader believe that the study is not applicable to his/her practice. The study started with 100 but only saw 90 at 6 months and 82 at 12 months. It took place in Australia. This was a tertiary care center. The follow-up stopped at a relatively short time. These are not necessarily bad things, but reasons to view the data in perspective and with a bit of a jaundiced eye.
As every practitioner tries to find the next best service to provide the patient, comparisons with the gold standard traditional therapy are necessary. Part of the limitations in that search centers around the fact that each physician's "gold standard" may be different. Here, the authors report that the TVT-O appears comparable to Burch colposuspension and the retropubic TVT. The numbers compared are similar, but they are not compared head to head in a classic, randomized, controlled trial. As a result, each reader is left with the challenge of determining whether it is better or not in his/her practice. I have personally not performed a trans-obturator procedure, but am convinced that they might have a place in my practice. You might say that my statement is a bit wishy-washy and noncommittal. You would be absolutely right. I'm just not sure where it fits in my practice at this time. It certainly looks like a "sexy" procedure with a lot of upside potential.
I practice with 2 highly skilled, fellowship-trained urogynecologists. They are helping me sort through the data and clinical outcomes just as they are trying to organize in their own minds how this technique should fit into our armamentarium of surgical offerings. With the growing number of patients needing this type of procedure, the surgical options are increasing even more. Every reader has probably already been approached about new materials, and new approaches, and better outcomes. Follow-up data beyond a year or so are sorely lacking in many cases.
As with this paper, "Let the buyer beware." In this case, the buyer is you, the surgeon, who is serving as advocate for the ultimate buyer, the patient. I am confident that we are all trying to find the best procedure for each patient. We know that one size does not fit all and we also know what works in our hands. Let's be good consumers and choose wisely, not just once, but repeatedly. Everytime we book a case in the operating room, let's ask ourself whether this is the best operation we can do for this patient. I know that the patient would want us to do so.