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

Patient Satisfaction Clinical Trial

— LOVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04680897
• Other study ID #: IRB00070386
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female Sexual Dysfunction
• Patient Satisfaction

Intervention

Behavioral:
• Early restriction release
Participants will no longer have restrictions on vaginal penetration 2 weeks after surgery.
• Standard restriction recommendation
Participants will return to intercourse after 6 weeks

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina
United States	Northwestern Medicine	Chicago	Illinois
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days until resumption of vaginal penetration		week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Urinary incontinence	To determine if there is similar continence in patients who resume intercourse early vs standard following isolated mid-urethral sling	week 12