Mid-urethral sling (MUS) surgery is common for the treatment of urinary incontinence and women are typically advised to refrain from vaginal intercourse for 6 weeks. However, animal models demonstrate wound healing at 2 weeks.  The primary aim of this trial was to compare satisfaction between women counseled to refrain from intercourse for 2 weeks (early) versus 6 weeks (standard) after mid-urethral sling (MUS) surgery. The secondary aims compared preference for the alternative randomization assignment, time to resumption of intercourse, and adverse events.

This multicentered, randomized trial enrolled sexually active women with a male partner planning isolated retropubic MUS for stress incontinence at four sites in the United States. We excluded non-English speakers, women with prior incontinence or mesh-based prolapse surgery, poorly controlled diabetes, pregnancy, history of pelvic radiation, and current smoking. Preoperatively, patients completed UDI-6 and PISQ-IR questionnaires. Patients were examined 2 weeks postoperatively, and those with intact vaginal incision were randomized to 2- or 6-week periods of restriction from vaginal penetration. Those with vaginal wound disruption on 2-week exam exited the study. Randomized patients returned 3 months postoperatively and underwent repeat pelvic examination and questionnaires. The primary outcome was satisfaction regarding ability to return to vaginal penetration, measured on a 5-point Likert scale. Postoperative day of resumption of intercourse was self-reported. At 80% power and alpha of 0.05, we needed to randomize 59 subjects to each group to detect a difference of 80% vs 54% satisfaction in the early vs. standard groups, respectively.

From 4/2021 to 6/2024, 298 women were screened and 155 enrolled. Of these, 30 did not follow up at 2 weeks, and 1 exited the study for wound disruption. Therefore, 124 women were randomized, 62 to the early (2 week) and 62 to the standard (6 week) group. At baseline, there were no demographic differences, and UDI-6 and PISQ-IR results were similar (Table). At 3 months, 51 (82%) in the early versus 45 (72%) in the standard group returned for follow up. Satisfaction with return to vaginal penetration was 68% (28/41) and 65% (26/40) in the early vs. standard groups, respectively (p=0.93). The median reported day of return to intercourse was 19 (16, 26) for the early versus 43 (41, 49) for the standard group. Preference for the alternate randomization group was 12% (5/42) in the early versus 45 % (18/40) in the standard group (p=0.0012). There were 0 cases of mesh exposure and 8/39 (21%) in the early vs. 5/39 (13%) standard resumption (p=0.54) groups reported dyspareunia at 3 months. Both groups demonstrated significant improvement in UDI-6 and PISQ-IR responses at 3 months with no difference between groups.

Women preferred the choice of returning to sexual activity after 2 versus 6 weeks after MUS without any negative impact on urinary incontinence results or mesh exposure.

Resumption of vaginal intercourse after 2 versus 6 weeks following MUS resulted in similarly high satisfaction with no adverse impact on efficacy, mesh exposure, or dyspareunia. As significantly more women preferred early resumption, surgeons should revise sexual activity restrictions to 2 weeks.