Prophylactic placement of a retropubic midurethral sling during surgery for vaginal prolapse approximately halves the risk of stress urinary incontinence (SUI) after surgery, but increases the risk of adverse events.
Prophylactic placement of a retropubic midurethral sling during surgery for vaginal prolapse approximately halves the risk of stress urinary incontinence (SUI) after surgery, but increases the risk of adverse events.
Published in The New England Journal of Medicine, the findings come from a 7-center, single-blind trial involving more than 300 women with apical or anterior prolapse but without symptoms of SUI before surgery, who were randomized to either a midurethral sling or sham incisions during surgery.
At 3 months post-surgery, 23.6% of the sling group versus 49.4% of the sham group were incontinent. The number needed to treat with a sling to prevent 1 case of incontinence at 3 months post-surgery was 3.9. Interestingly, the investigators noted that although fewer women receiving a sling had a positive cough stress test or bothersome symptoms of sui, the percentage of women receiving postoperative treatment of incontinence was about the same in both groups.
At 12 months, the percentages of women experiencing incontinence were 27.3% and 43.0%, respectively. The number needed to treat was 6.3.
In terms of adverse effects, 6.7% of the sling group versus 0% of the sham group suffered a bladder perforation. Physicians managed all perforations during surgery; no long-term consequences occurred. Similarly, 31% versus 18.3%, respectively, experienced urinary tract infections; 3.1% versus 0%, respectively, experienced bleeding complications, and 3.7% versus 0%, respectively, could not empty their bladder completely at 6 weeks post-surgery.
Mean operative time was about 11 minutes longer in the sling versus the sham group, and mean estimated blood loss was about 24 mL higher, but no significant differences existed between the groups at either time period in other pelvic floor symptoms, quality of life, sexual function, or pain. No mesh erosions occurred in the sling group during the 12-month period.
The investigators noted that women with a positive prolapse-reduction stress test before surgery seemed to benefit more from a sling at 3 months post-surgery than those with a negative test, but that was not apparent at 12 months. They also pointed out that almost 5% of the sham group returned to surgery for a sling within the year after prolapse surgery, while only 2.4% of the sling group returned to surgery within a year for sling removal.
Read other articles in this issue of Special Delivery
FDA adds boxed warning to fezolinetant for rare serious liver injury
Published: December 17th 2024 | Updated: December 17th 2024The FDA has added a boxed warning for fezolinetant (VEOZAH; Astellas), highlighting the rare occurrence of serious liver injury in patients taking the menopause treatment.
Read More