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Intercourse Restrictions After Mid-Urethral Sling for Female Sexual Dysfunction (LOVE Trial)

N/A
Waitlist Available
Led By Catherine A Matthews, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to comprehend the concept of randomization
At least 21years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

LOVE Trial Summary

This trial is looking at whether the current standard of six weeks of no vaginal penetration following a mid-urethral sling affects patient satisfaction.

Who is the study for?
This trial is for women over 21 with stress or mixed urinary incontinence planning to have a mid-urethral sling operation. Participants must be sexually active at least once every two weeks and understand the concept of randomization. Exclusions include previous incontinence/prolapse surgeries, uncontrolled diabetes, incarceration, pelvic radiation history, non-English speakers, pregnancy, and current smokers.Check my eligibility
What is being tested?
The LOVE Trial is examining whether early restriction release (3 weeks) on vaginal intercourse after mid-urethral sling surgery affects patient satisfaction compared to the standard recommendation of a 6-week restriction. The study aims to provide evidence-based guidelines for post-operative sexual activity.See study design
What are the potential side effects?
While specific side effects are not listed for this trial's interventions since it focuses on timing restrictions rather than medication or procedures, potential concerns may include wound complications or pain related to earlier return to sexual activity.

LOVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the idea of being randomly assigned to different treatment groups.
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I am at least 21 years old.

LOVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant satisfaction rating
Secondary outcome measures
Number of Wound complications - granulation tissue
Number of Wound complications - mesh erosion
Number of Wound complications - mesh exposure
+4 more

LOVE Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard GroupExperimental Treatment1 Intervention
Participants may resume vaginal penetration at 6 weeks.
Group II: Early GroupExperimental Treatment1 Intervention
Participants may resume intercourse at 2 weeks

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,067 Total Patients Enrolled
Catherine A Matthews, MDPrincipal InvestigatorWake Forest Health Sciences
3 Previous Clinical Trials
380 Total Patients Enrolled

Media Library

Female Sexual Dysfunction Clinical Trial 2023: Standard restriction recommendation Highlights & Side Effects. Trial Name: NCT04680897 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited to partake in this medical experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this experiment is currently searching for patients - the original post was made on April 16th 2021 and it has been updated most recently on October 26th 2022. A total of 116 participants are needed from three separate sites."

Answered by AI

Are there still openings available for prospective participants of this trial?

"Affirmative. As per the information hosted on clinicaltrials.gov, this study is recruiting participants; it was first posted on April 16 2021 and has been modified most recently on October 26 2022. The trial requires 116 patients to be enlisted from 3 assorted medical centres."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling
2021. "LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04680897.
~3 spots leftby Jun 2024
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