LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling

Completed · Not applicable

Conditions studied: Patient Satisfaction, Female Sexual Dysfunction

In brief

There are no prospective, randomized studies addressing vaginal penetration restrictions following mid-urethral slings. There is a single cohort study examining expedited recovery following vaginal prolapse repair which advised 3-weeks of vaginal penetration restrictions. This study reported an earlier return to intercourse in the 3-week group than in the retrospectively collected control group where 6-weeks of restriction were advised. This study did not evaluate the impact of early versus later return to sexual activity on wound complications, mesh exposure rates, pain or satisfaction. It is important to develop evidenced-based recommendations on post-operative sexual activity restrictions. The purpose of this research study is to understand if the "standard" 6-week restriction on vaginal penetration/intercourse after mid-urethral sling affects patient satisfaction

Key facts

Study ID

NCT04680897

Run by

Wake Forest University Health Sciences

People needed

155

Starts

2021-04-16

Expected to finish

2024-09-27

Last updated by the study team

2025-03-19

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least 21years of age
• Women with stress or mixed urinary incontinence who are undergoing a planned, isolated, synthetic mid-urethral sling with cystoscopy via retropubic, transobturator or single-incision approach.
• Sexually active with ≥1 male or female partner with a frequency of at least once every 2 weeks
• Ability to comprehend the concept of randomization
• Willing to remain compliant with the instructions and study follow-up visits

You may not qualify if…

• History of prior surgery for incontinence including mid-urethral sling, fascial sling
• History of prior surgery for prolapse with transvaginal mesh
• Diabetic with Hgb A1C ≥ 8.0 % (elevated A1C is associated with delayed wound healing12 and 8.0 has been identified as a cutoff over which there are more complications postoperatively13
• Pregnant
• Incarcerated
• History of pelvic radiation
• Current smoker (known risk factor for mesh exposure)
• Non-English speaker

Where it is running

• Northwestern Medicine — Chicago, Illinois, United States
• Atrium Health — Charlotte, North Carolina, United States
• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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