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

NCT04680897 | Completed

• 1 other identifier: IRB00070386
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

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 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

Keywords

mid-urethral sling

Outcome Measures

Primary Outcomes (1)

• Participant satisfaction rating

  To determine if there is improved satisfaction with decreased length of restricted vaginal penetration following mid-urethral sling. The primary outcome will be patient satisfaction with ability to return to sexual function as measured on a 5-point Likert scale with the question: "How satisfied were you with your ability to return to vaginal penetration following surgery?" (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree

  week 12

Secondary Outcomes (7)

• Number of days until resumption of vaginal penetration

  week 12

• Number of Wound complications - wound separation

  week 12

• Number of Wound complications - mesh exposure

  week 12

• Number of Wound complications - mesh erosion

  week 12

• Number of Wound complications - granulation tissue

  week 12

Study Arms (2)

Standard Group

OTHER

Participants may resume vaginal penetration at 6 weeks.

Behavioral: Standard restriction recommendation

Early Group

OTHER

Participants may resume intercourse at 2 weeks

Behavioral: Early restriction release

Interventions

Early restriction release BEHAVIORAL

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

Early Group

Standard restriction recommendation BEHAVIORAL

Participants will return to intercourse after 6 weeks

Standard Group

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Gender eligibility is not based on gender identity but on patients with female urethral anatomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (3)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Atrium Health

Charlotte, North Carolina, 28207, United States

Location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Catherine A Matthews, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The "early" group will be given instructions that allow them to return to vaginal penetration/intercourse after 2 weeks. The "standard" group will be given postoperative instructions that allow them to return to intercourse after 6 weeks. Both groups will be able to return to other physical activities as they feel able

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: April 16, 2021
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)