Introduction
The CARE study was conducted to estimate the utility of the Burch colposuspension at the time of sacrocolpopexy in stress continent women. Recent evidence suggests that the Burch colposuspension is less effective than a rectus fascial sling to treat stress incontinence symptoms in women with and without prolapse and that the efficacy of both studied procedures decrease over the initial two years following surgery. To provide longer-term information about the optimal strategy for minimizing bothersome bladder symptoms at the time of prolapse surgery, the CARE trial included a two-year assessment. In addition, concomitant colposuspension can affect vaginal support, an effect best appreciated over time.
Objectives
The aims of this report are to compare, between women that did and did not undergo Burch colposuspension at the time of sacrocolpopexy, bladder, functional, sexual and anatomical outcomes,two years following the index surgery and to report complications related to surgery over the two years period.
Methods
In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. The outcomes included urinary symptoms, other pelvic symptoms and pelvic support. Standardized POP-Q examinations and validated outcome measures including the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) were completed before surgery and at several post-operative intervals, including two years.
Results
This analysis is based on 302 of 322 randomized participants. Most were Caucasian (94%) with a mean age of 62±10 years (mean±SD). Two years after surgery, 32.0% and 45.2% of women in the Burch and control group met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence),p=0.026,. The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women and this was not affected by concomitant Burch (p=0.18). There was a trend towards fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, p=0.085). Twenty participants experienced mesh or suture erosions.
Conclusions
The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at two years. Apical anatomic success rates are high and not affected by concomitant Burch.
Keywords
Urinary Incontinence, Sacrocolpopexy, Randomized Clinical Trial, Burch Colposuspension