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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 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 155 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04680897
The ClinicalTrials.gov registry entry for NCT04680897 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Early restriction release is the first listed.
NCT04680897 reports 0 study locations.
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.
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