Late-Breaking: Limits On Vaginal Intercourse after Mid-urEthral Sling (LOVE Trial)

Wednesday, October 23, 2024

1:50 PM – 2:00 PM EDT

Location: Liberty Ballroom (Meeting Level 4)

Table 2: Patient satisfaction with timing of postoperative return to vaginal intercourse

LOVE table 1 abstract 8-29.docx LOVE table 2 abstract 8-29.docx

Objectives: We primarily aimed to compare satisfaction between women restricted from sexual intercourse for 2 weeks (early) versus 6 weeks (standard) after mid-urethral sling (MUS) surgery. Secondary aims compared preference for the alternative randomization assignment, time to resumption of intercourse, and adverse events.

Methods: This multicentered, randomized trial enrolled sexually active women with male partners 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 incisions were randomized to 2- or 6-week 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 with restrictions on vaginal penetration, measured on a 5-point Likert scale. Satisfaction was defined by a response of 4 (“satisfied”) or 5 (“very satisfied”). Postoperative day of resumption of intercourse was self-reported. At 80% power and alpha of 0.05, we planned 59 participants in each group to detect a difference of 80% vs 54% satisfaction in the early vs. standard groups, respectively.

Results: 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, UDI-6, or PISQ-IR differences (Table 1). 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=0.84). The median (IQR) 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.

Conclusions: 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.

Disclosure(s):

Katherine N. Hines, MD: No financial relationships to disclose

Sarah Collins, MD, FACOG, FACS: No relevant disclosure to display

Kimberly Kenton, MD, MS: No relevant disclosure to display

Erinn Myers, MD: No relevant disclosure to display

Hoa T. Nguyen, MD: No financial relationships to disclose

Julia Geynisman-Tan, MD: No relevant disclosure to display

Gregory B. Russell, MS: No financial relationships to disclose

Catherine A. Matthews, MD: No relevant disclosure to display

Candace Parker-Autry, MD: No financial relationships to disclose

Presenting Author(s)

Katherine N. Hines, MD (she/her/hers)

Physician
Wake Forest School of Medicine
Virginia Beach, Virginia, United States

Disclosure(s): No financial relationships to disclose

Co-Author(s)

Sarah Collins, MD, FACOG, FACS (she/her/hers)

Associate Professor of Obstetrics & Gynecology
The University of Chicago Pritzker School of Medicine
Chicago, Illinois, United States

Disclosure(s): No relevant disclosure to display
KK

Kimberly Kenton, MD, MS

Professor
University of Chicago
Chicago, Illinois, United States

Disclosure(s): No relevant disclosure to display
EM

Erinn Myers, MD (she/her/hers)

Associate Professor
Atrium Health
Charlotte, North Carolina, United States

Disclosure(s): No relevant disclosure to display
Hoa T. Nguyen, MD (she/her/hers)

Urogynecology and Reconstructive Pelvic Surgery Fellow
Northwestern
Chicago, Illinois, United States

Disclosure(s): No financial relationships to disclose
Julia Geynisman-Tan, MD

Assistant Professor
Northwestern University
Chicago, Illinois, United States

Disclosure(s): No relevant disclosure to display
GR

Gregory B. Russell, MS

Senior Biostatistician
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States

Disclosure(s): No financial relationships to disclose

Co-Author(s)

Candace Parker-Autry, MD (she/her/hers)

Associate Professor
Urogynecology, Department of Urology, Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States

Disclosure(s): No financial relationships to disclose

Co-Author(s)

Catherine A. Matthews, MD (she/her/hers)

Professor, Division Head and Fellowship Director; Female Pelvic Health
Wake Forest University School of Medicine
Wisnton-Salem, North Carolina, United States

Disclosure(s): No relevant disclosure to display