In the last month, two clinical trials have been published in the New England Journal of Medicine that are likely to have a lasting impact on the practice of FPMRS. [Full Disclosure: I am a co-author on both]
On May 24th, the UITN published the results of the Value of Urodynamic Evaluation (ValUE) trial in an article titled “A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery” NEJM 2012 366(21):1987-97. In this noninferiority trial involving 11 centers and 53 participating surgeons, 630 American women with uncomplicated stress incontinence (pure stress and stress-predominant mixed UI) were randomized to receive office evaluation only or office evaluation and urodynamic testing before planned SUI surgery. The treatment success rates at one year were nearly equivalent in both groups; 77.2% in the office evaluation only group and 76.9% in the urodynamic-testing group. The authors concluded that for women with uncomplicated stress urinary incontinence, preoperative office evaluation alone (positive cough stress test, normal PVR, negative UA and assessment of urethral mobility) was not inferior to evaluation with urodynamic testing for outcomes at 1 year. The authors also concluded that these results argue against routine preoperative urodynamic testing in patients with uncomplicated stress urinary incontinence. Importantly, this study did not address more complicated populations such as urge-predominant incontinence, previous incontinence surgery, neurologic disease or concurrent prolapse. AUGS has already received many inquiries about our position on this study and we will be posting a position statement soon that supports the studies conclusions.
Today, the PFDN published the results of the OPUS trial in an article titled "A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair" NEJM 2012; 366: 2358-67. This study randomized 337 women with stage 2-4 prolapse without stress urinary incontinence undergoing vaginal prolapse surgery to recieve a TVT or sham incisions. The rate of de novo stress urinary incontinence was significantly less 3 months (23.6% vs 49.9%) and 12 months (27.3% vs 43%) after surgery in those receiving a TVT. The number needed to treat with a sling to prevent one case of new stress incontinence at 12 months was 6.3. Much like the CARE trial, women with a positive preop prolapse reduction stress test had more benefit than those with a negative preop stress test however both groups did better with the TVT than without. This raises the question, should all continent women undergoing vaginal prolapse surgery get a prophylactic mid-urethral sling regardless of preop stress test results? The answer will largely depend on the individual surgeon and patient's assessment of the risk-benefit ratio. While expected side effects like bladder perforation, bleeding and incomplete emptying were higher in the TVT group, there was no difference in serious adverse events and importantly there were no mesh erosions in any of the patients who recieved TVT.
In my opinion, both of these articles are landmark studies in our specialty and will certainly get lots of discussion and be cited frequently. They both speak to the real benefit that NIH support provides for research in our field. Given their inevitable impact, I encourage you to read them.