Status:
COMPLETED
LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Patient Satisfaction
Female Sexual Dysfunction
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief 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 pr...
Detailed Description
The lifetime risk of surgery for stress urinary incontinence in women is 13.6%. Women are typically instructed to avoid strenuous physical activity and vaginal penetration for 6 weeks following synthe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2024
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04680897
Start Date
April 16 2021
End Date
September 27 2024
Last Update
March 19 2025
Active Locations (3)
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1
Northwestern Medicine
Chicago, Illinois, United States, 60611
2
Atrium Health
Charlotte, North Carolina, United States, 28207
3
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157