Worse side effects following transobturator sling [Classics Series]

Classics Series, Landmark Trials in Medicine

1. Retropubic tension free vaginal tape (TVT) and transobturator tape (TOT) were associated with similar success rates for treatment of stress urinary incontinence at one year.

2. TOT was associated with worrisome side effects like obturator neuropathies, while TVT was associated with more readily preventable and treatable side effects of urinary retention and urinary tract infections.

Original date of publication: June 2010

Study Rundown: Urinary incontinence affects up to 50% of women. Stress urinary incontinence (SUI) is the involuntary loss of urine during increases in intraabdominal pressure, such as that which occur with exertion, laughing or coughing. Until the mid 1990s, the standard surgical treatment for SUI was the Burch colposuspension, where the anterior vaginal wall at the bladder neck is suspended to the iliopectineal ligaments, as well as the fascial sling, where a portion of rectus fascia is fashioned as a hammock to support the dependent portion of the bladder. Development of the synthetic mesh sling placement in the 1990s permitted a lower cost treatment, improved post-surgical success rates and shorter post-operative hospital stays (see background reading). Two approaches were developed for synthetic mesh sling placement: the retropubic midurethral sling (aka tension free vaginal tape tape, TVT) and the transobturator midurethral sling (aka transobturator tape, TOT). The retropubic TVT was developed first and quickly became the standard of care in the early 2000’s. However, retropubic placement of this mesh introduces risks of injury to bowel or bladder during placement. The transobturator tape midurethral sling was developed to minimize the risk of such injury by passing the tape retroperitoneally, through the obturator foramen. However, in the early 2000’s, physicians and researchers did not have a clear sense of how the risks and benefits differed by procedure. In the trial of midurethral slings (TOMUS) study, researchers set out to compare the safety and efficacy of TVT and TOT.

This landmark study demonstrated that TVT and TOT were associated with similar rates of objectively and subjectively assessed success rates at 1 year of follow-up. However, the side effects from TOT, most notably obturator neuropathies, are harder to prevent and treat than those associated with TVT, which included urinary tract infections and urinary retention leading to a higher rate of reoperation in a small percentage of women. Assessment of long-term success rates, side effects and patient satisfaction with treatment would provide additional useful clinical information.

Click here to read study in NEJM

Relevant reading: Tension free vaginal tape for surgical treatment of stress urinary incontinence

In-Depth [randomized controlled trial]: A total of 565 women with urinary stress incontinence were randomized to undergo either retropubic (n=298) or transobturator midurethral sling placement (n=299) and completed a 12-month post-operative assessment. Primary outcome was treatment success at 12 months defined by both objective criteria (e.g. cough stress tests and pad tests) and subjective criteria (e.g. self-reported symptomatology).

At 12-months post-op, rates of treatment success were similar between TVT and TOT when assessed objectively (80.8% vs. 77.7%) or subjectively (62.2% vs. 55.8%). Compared to women in the TVT group, women in the TOT group experienced higher rates of neurologic symptoms in the first post-operative year (4.0% vs. 9.4%, p=0.01). Rates of post-operative voiding dysfunction requiring surgery were higher in the TVT group compared to the TOT group (2.7% vs. 0%, p=0.004).

Image: PD

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