NEW YORK (Reuters Health) - Single-incision mini-slings used to treat female stress urinary incontinence are not inferior to older midurethral slings, according to a new study.
"The bottom line of this trial is that women affected by stress urinary incontinence have two good options, if available to them, for outpatient surgical management with 1- to 2-week recovery periods," write Drs. Ingrid Nygaard and Peggy Norton of the University of Utah School of Medicine, in Salt Lake City, in an editorial in the New England Journal of Medicine, where the study appears.
"The single-incision (mini-sling) approach can be used without general anesthesia and avoids possible abdominal injury but is associated with higher likelihoods of repeat surgery and dyspareunia than midurethral mesh slings," they note.
The pragmatic, government-funded study at 21 hospitals in the United Kingdom involved 596 volunteers with a mean age of 50 years. General anesthesia was used in 25% of the women randomly assigned to the single-incision mini-sling versus 91% of the women who received a standard midurethral sling.
At 15 months, the patient-reported success rate - defined as a response of very much improved or much improved on the Patient Global Impression of Improvement questionnaire - was 79% among mini-sling recipients versus 76% for those who received a midurethral sling (P<0.001 for noninferiority).
At the 36-month mark, the success rates were 72% and 67% respectively.
Although other measures of success seemed comparable between the two groups, 12% of women in the mini-sling group reported dyspareunia versus 5% who received a mini-sling, a significant difference.
At two weeks, women who received a mini-sling seemed to experience less postoperative pain.
About 13% of women in the United States and 4% of women in the United Kingdom are expected to have surgery for stress urinary incontinence sometime in their lives.
The researchers also measured success with a 24-hour pad test, with 86% in the mini-sling group passing the test versus 76% with the conventional sling.
"There were no material between-group differences in scores on several scales assessing lower urinary tract symptoms, quality of life, and sexual function," Dr. Mohamed Abdel-Fattah of the University of Aberdeen and colleagues report. However, "dyspareunia and coital incontinence were more common with mini-slings than with midurethral slings at almost all time points."
Mini-sling recipients were more likely to have thigh or groin pain at 15 months, but not at 36 months.
Also, 9% of the women who received a mini-sling and 5% in the midurethral slings group ultimately had further surgical treatment (P=0.12). The rates of further surgery for stress urinary incontinence were 2.5% and 1.1%, respectively.
The rates of tape or mesh exposure were 3.3% with a mini-sling and 1.9% with a midurethral sling over three years.
The researchers are planning to follow the patients for 10 years.
Dr. Abdel-Fattah did not respond to questions in emails from Reuters Health.
SOURCE: https://bit.ly/35cSY6P and https://bit.ly/3iA6FQb The New England Journal of Medicine, online March 30, 2022.
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