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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Limits On Vaginal Intercourse After Mid-urEthral Sling (LOVE Trial)

Conditions
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Patient Satisfaction, Female Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Early restriction release
* Behavioral: Standard restriction recommendation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Group<br>Participants may resume vaginal penetration at 6 weeks. | Behavioral: Standard restriction recommendation<br>* Participants will return to intercourse after 6 weeks<br>|
| Other: Early Group<br>Participants may resume intercourse at 2 weeks | Behavioral: Early restriction release<br>* Participants will no longer have restrictions on vaginal penetration 2 weeks after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days until resumption of vaginal penetration |  | week 12 | 
| Number of Wound complications - wound separation | 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 | 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 | 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 | 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 | 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 | To determine if there is similar continence in patients who resume intercourse early vs standard following isolated mid-urethral sling | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mid-urethral sling