Clinical trial NCT06840093: Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial
Official title: Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Restriction
Midurethral Sling
Mesh
Stress Urinary Incontinence
Keywords: postoperative restrictions
midurethral sling
mesh
stress urinary incontinence
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to better understand optimal restrictions for patients postoperatively following a mesh urethral sling placement for patients with stress urinary incontinence.

Patients undergoing a midurethral sling procedure will be assigned to one of two groups. One group with be given standard postprocedural restrictions including instructions to avoid moderate activity and no lifting over 15lbs for six weeks after surgery. The other group will have fewer restrictions, with no restrictions on activity or lifting.

Participants will complete surveys at 2 weeks, 3 months and 1 year following their procedure to help providers better understand how patients are following postoperative restrictions and if there were any differences in the outcome of the procedure between the two groups.

Detailed description: There is a growing body of evidence suggesting that strict postoperative restrictions may not be beneficial. Emerging data indicate that these restrictions do not significantly influence short- or long-term outcomes and may even have detrimental effects, such as increasing the incidence of venous thromboembolism and overall deconditioning.

Due to limited data on optimal postoperative restrictions following midurethral sling surgery, providers struggle to offer consistent, evidence-based recommendations. This variability can lead to inconsistent patient counseling, underscoring the need for further research to support or challenge universal postoperative restrictions.

Recent studies indicate that limited postoperative restrictions following pelvic organ prolapse surgery do not result in inferior outcomes. O'Shea et al. found that expedited activity post-surgery did not negatively affect anatomic or symptomatic results. Similarly, Mueller et al. reported that patients who resumed preoperative activities experienced fewer prolapse and urinary symptoms, with no inferior short-term anatomical outcomes. Arunachalam et al. also demonstrated that specific postoperative instructions did not significantly influence physical activity levels.

The latest guidelines for mesh hernia repair, the most common general surgery procedure involving synthetic mesh, recommend that patients resume activities without restriction post-surgery. Previous concerns that increased intra-abdominal pressure might lead to sling migration or mesh incorporation have not been substantiated. Studies show that abdominal pressures during daily activities overlap with those during physical exertion, and since patients cannot avoid daily activities like coughing or transitioning from sitting to standing, there is no physiological basis for strict restrictions.

While recent literature supports the safety of limited postoperative restrictions after pelvic prolapse surgery, this has not been validated for mid-urethral sling procedures. Traditionally, patients are advised to reduce activity for six to eight weeks post-surgery, which may deter physically active individuals from opting for the procedure. Given that the mid-urethral sling is considered the gold standard for treating stress urinary incontinence, relaxing restrictions and allowing quicker return to baseline activity could encourage more individuals to undergo this surgery.

Secondary Aims

* Compare incidence of adverse events, including mesh exposure, in each group
* Compare self-reported activity levels between groups
* Compare post-operative pain scores at 2 weeks and 3 months postoperatively
* Compare incidence of new onset dyspareunia

Eligibility criteria: Inclusion: Undergoing isolated synthetic mesh retropubic midurethral sling placement Exclusion criteria: Non-English speaking, incarcerated, cognitive impairment precluding informed consent, unable to ambulate without the assistance of an ambulation device, concurrent prolapse procedure

Primary outcomes:
measure: Urogenital Distress Inventory
timeFrame: 3 months and 1 year postoperatively
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Primarily 3 months, will offer 1 year survey follow up
measure: Self-reported activity
timeFrame: 2 weeks and 3 months postoperatively
measure: Post-operative pain scores
timeFrame: 2 weeks and 3 months postoperatively
measure: Changes to Sexual Function
timeFrame: 3 months and 1 year postoperatively
measure: Patient Impression of Improvement
timeFrame: 2 weeks, 3 months and 1 year postoperatively
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
References: