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

NCT04680897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2025-03-19

No results posted yet for this study

Summary

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

Conditions

  • Patient Satisfaction
  • Female Sexual Dysfunction

Interventions

BEHAVIORAL

Early restriction release

Participants will no longer have restrictions on vaginal penetration 2 weeks after surgery.

BEHAVIORAL

Standard restriction recommendation

Participants will return to intercourse after 6 weeks

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Catherine A Matthews, MD · Wake Forest Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2024-09-27
Completion
2024-09-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680897 on ClinicalTrials.gov