Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial

Last updated: March 26, 2025
Sponsor: University of Iowa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

Limited Restrictions

Standard Restrictions

Clinical Study ID

NCT06840093
202407515
  • Ages 18-99
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion: Undergoing isolated synthetic mesh retropubic midurethral sling placement

Exclusion

Exclusion criteria: Non-English speaking, incarcerated, cognitive impairment precluding informed consent, unable to ambulate without the assistance of an ambulation device, concurrent prolapse procedure

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Limited Restrictions
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
June 30, 2027

Study 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

Connect with a study center

  • University of Iowa Health Care

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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