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NCT Number: NCT06840093

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Joseph Kowalski, MD

CONTACT

[email protected]

Leanne E Brechtel, MD

PRINCIPAL_INVESTIGATOR

Leanne E Urogynecology Fellow, MD

CONTACT

[email protected]

716-480-8583

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limited Restrictions

Behavioral

Patients will receive a handout with the following instructions: After discharge from the hospital, resume your normal activities as soon as you feel comfortable. There is no weight limit on lifting. There are no specific activities you should avoid (other than pelvic rest as described below). We recommend pelvic rest, nothing in the vagina (no intercourse, hot tubs, tub bathing or swimming) for 2 weeks.

Standard Restrictions

Behavioral

Patient will receive a handout with the following instructions: After discharge from the hospital, avoid doing any strenuous activity (any activity that requires so much exertion that you cannot have a conversation comfortably while doing it). Do not lift anything over 15 pounds for 6 weeks after surgery. For 6 weeks, we recommend complete pelvic rest, nothing in the vagina (no intercourse, hot tubs, tub bathing or swimming).

Primary outcomes

  1. Urogenital Distress Inventory

    Time frame: 3 months and 1 year postoperatively

    Questionnaire to assess the severity of lower urinary trat symptoms. Baseline compared to 3 months postoperatively with the hypothesis limited postoperative restrictions will result in non-inferior urinary symptoms compared to standard restrictions

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Primarily 3 months, will offer 1 year survey follow up

    All adverse events will be recorded for both groups

  2. Self-reported activity

    Time frame: 2 weeks and 3 months postoperatively

    Using the Rapid Assessment of Physical Activity questionnaire, we will compare groups to assess if activity levels were different between the groups

  3. Post-operative pain scores

    Time frame: 2 weeks and 3 months postoperatively

    Comparing post-operative pain scores at 2-weeks and 3-months post-operatively using the Numerical Pain Rating Scale from 0-10

  4. Changes to Sexual Function

    Time frame: 3 months and 1 year postoperatively

    The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) will be administered at baseline, 3 months postoperatively and 1 year postoperatively to compare

  5. Patient Impression of Improvement

    Time frame: 2 weeks, 3 months and 1 year postoperatively

    Using the Patient Global Impression of Improvement survey, will assess patient satisfaction and overall improvement

Study contacts

Contact information is provided by the study sponsor or research team.

Leanne Brechtel, MD

CONTACT

[email protected]

+1 319 356 2294

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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