Limits on vaginal intercourse after mid-urethral sling: a randomized trial.

Abstract

<h4>Background</h4>Women undergoing synthetic mid-urethral slings for stress urinary incontinence are typically advised to refrain from penetrating intercourse for 4 to 6 weeks postprocedure, yet no prospective studies inform this recommendation.<h4>Objective</h4>To compare satisfaction between women restricted from sexual intercourse for 2 weeks (early) vs 6 weeks (standard) after retropubic sling surgery. Secondary aims compared preference for the alternative randomization assignment, sexual function including de novo dyspareunia, urinary incontinence symptoms, and adverse events.<h4>Study design</h4>This is a randomized, multicentered clinical trial of sexually active women undergoing synthetic retropubic sling. At baseline, women completed the Urinary Distress Inventory 6 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecology Association-Revised questionnaires. At 2 weeks postsurgery, if the vaginal incision was intact, women were randomized to early or standard restrictions for vaginal intercourse. Women returned at 3 months for repeat pelvic examination and questionnaires. The primary outcome, collected at 3 months, was patient satisfaction (very satisfied or satisfied) on a 5-point Likert scale with ability to return to vaginal intercourse. Using a 2-sample proportion test with type 1 error set to 0.05% and 80% power, we needed 59 women per group to detect a difference of 80% vs 54% satisfaction in the early vs standard groups, respectively.<h4>Results</h4>Between April 2021 and June 2024, 124 women were randomized with 62 per group across 4 centers in the United States. Mean age was 47 years. The majority were premenopausal (72%) and Caucasian (85%). Satisfaction with return to vaginal penetration was 66% (31/47) and 68% (30/44) with an estimated difference in proportions and 95% confidence interval of 2.5% (-19.3%, 24.3%) in the early vs standard groups, respectively (P>.99). Preference for the alternate randomization group was 13% (6/47) in the early vs 43% (19/44) in the standard group (P=.0019). There were 0 cases of mesh exposure. De novo dyspareunia at 3 months was reported in 6/36 (17%) in the early vs 2/29 (7%) in the standard resumption group (P=.28). There was marked improvement in urinary incontinence and sexual function symptoms at 3 months with no difference between groups.<h4>Conclusion</h4>Permission to resume vaginal intercourse after 2 vs 6 weeks following isolated retropubic sling resulted in similarly high satisfaction with no adverse impact on efficacy, mesh exposure, or sexual function. Larger studies are needed to investigate the impact of early return to sexual function on de novo dyspareunia. Women significantly (P=.0019) preferred the option of resuming penetrating intercourse after 2 weeks.