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NCT04680897 · ClinicalTrials.gov registry record · NA
LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 155
- Enrollment target
NCT04680897: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT04680897 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 155 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04680897, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
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
Primary Outcome
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
Interventions
- BEHAVIORAL Early restriction release
- BEHAVIORAL Standard restriction recommendation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2021-04-16 |
| Est. Completion | 2024-09-27 |
| Phase | NA |
What the finished NCT04680897 record still lists
NCT04680897 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Early restriction release is the first listed.
NCT04680897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04680897 about?
NCT04680897 is a clinical study titled "LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling". 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 earl...
What is the current status of trial NCT04680897?
This trial is currently completed. It is a NA study. The enrollment target is 155 participants. The study started on 2021-04-16. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT04680897?
The interventions under investigation include: Early restriction release (BEHAVIORAL), Standard restriction recommendation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04680897?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04680897's enrollment target sits among peer trials
155 656th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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