- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680897
LOVE Trial: Limits On Vaginal Intercourse After Mid-urEthral Sling (LOVE)
Limits On Vaginal Intercourse After Mid-urEthral Sling (LOVE Trial)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 synthetic mid-urethral sling procedures. The historical rationale behind these instructions was to prevent disruption of vaginal incisions, promote wound healing, decrease recurrence risk and prevent complications such as mesh exposure. Very little medical evidence exists, however, to support these activity restrictions which can have a negative impact on satisfaction and quality of life. Findings from a single randomized trial challenge standard activity restrictions following pelvic organ prolapse repair. Participants were given conservative or liberal postoperative instructions and the liberal group experienced fewer prolapse and urinary symptoms at 3 months postoperatively; but there was no difference in satisfaction between groups. This study, however, did not investigate restrictions on vaginal penetration (both groups adhered to 6-week restrictions) and was not specific to women undergoing isolated sling procedures. 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.
Animal models suggest that wound healing occurs much sooner than 6 weeks post-surgery. In fact, epithelial wounds closed by primary intention typically re-epithelialize in just 24-48 hours. In a mouse-model with full-thickness vaginal injury, there was complete restoration of mucosal integrity by day 7 without surgical closure of the wound. Epithelial healing over mid-urethral sling could differ due to a known pro-inflammatory milieu in the setting of a mesh implant but the rate of epithelial closure over implanted synthetic mesh has not been specifically described. While earlier vaginal penetration could theoretically increase the risk of mesh exposure from the known baseline risk of 2-3%, this is unlikely following two weeks in a low risk population regardless of menopausal status. Vaginal atrophy has been identified as a risk factor for wound healing complications and vaginal mesh exposure and could interact with early resumption of intercourse. However, vaginal atrophy can be reversed with vaginal estrogen therapy and resultant risks mitigated.
Given the prevalence of mid-urethral slings for stress incontinence, it is important to develop evidenced-based recommendations on post-operative sexual activity restrictions. The purpose of this randomized trial, therefore, is to evaluate the impact of early (2 weeks) versus standard (6 weeks) removal of vaginal penetration restrictions in sexually active women undergoing mid-urethral sling procedures on sexual satisfaction and wound complications.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Catherine A Matthews, MD
- Phone Number: 336-716-4310
- Email: camatthe@wakehealth.edu
Study Contact Backup
- Name: Katherine N Hines, MD
- Phone Number: 803-622-1671
- Email: knhines@wakehealth.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Medicine
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28207
- Atrium Health
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard Group
Participants may resume vaginal penetration at 6 weeks.
|
Participants will return to intercourse after 6 weeks
|
Other: Early Group
Participants may resume intercourse at 2 weeks
|
Participants will no longer have restrictions on vaginal penetration 2 weeks after surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant satisfaction rating
Time Frame: week 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days until resumption of vaginal penetration
Time Frame: week 12
|
week 12
|
|
Number of Wound complications - wound separation
Time Frame: week 12
|
To determine if there are increased wound complications in patients following isolated mid-urethral sling with shorter duration of restrictions on vaginal penetration.
|
week 12
|
Number of Wound complications - mesh exposure
Time Frame: week 12
|
To determine if there are increased wound complications in patients following isolated mid-urethral sling with shorter duration of restrictions on vaginal penetration.
|
week 12
|
Number of Wound complications - mesh erosion
Time Frame: week 12
|
To determine if there are increased wound complications in patients following isolated mid-urethral sling with shorter duration of restrictions on vaginal penetration.
|
week 12
|
Number of Wound complications - granulation tissue
Time Frame: week 12
|
To determine if there are increased wound complications in patients following isolated mid-urethral sling with shorter duration of restrictions on vaginal penetration.
|
week 12
|
Number of Wound complications - vaginal pain
Time Frame: week 12
|
To determine if there are increased wound complications in patients following isolated mid-urethral sling with shorter duration of restrictions on vaginal penetration.
|
week 12
|
Urinary incontinence
Time Frame: week 12
|
To determine if there is similar continence in patients who resume intercourse early vs standard following isolated mid-urethral sling
|
week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine A Matthews, MD, Wake Forest Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00070386
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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