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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Mesh; Postoperative Restriction; Midurethral Sling
• Intervention / Treatment: Behavioral: Limited Restrictions; Behavioral: Standard Restrictions

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

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leanne Brechtel, MD; Phone Number: +1 319 356 2294; Email: leanne-brechtel@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Health Care
      • Contact: Joseph Kowalski, MD; Email: joseph-kowalski@uiowa.edu
      • Contact: Leanne E Urogynecology Fellow, MD; Phone Number: 716-480-8583; Email: leanne-brechtel@uiowa.edu
      • Principal Investigator: Leanne E Brechtel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Limited Restrictions; 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. If you are prescribed vaginal estrogen, you may restart usage 1 week after surgery. A physical exam will be performed at your two-week appointment to check how your incision is healing. If there are no complications noticed at this appointment, there are no further pelvic restrictions. You can resume all activities, including vaginal intercourse, as tolerated.	Behavioral: Limited Restrictions; 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.
Active Comparator: Standard Restrictions; 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). If you are prescribed vaginal estrogen, you may restart usage 1 week after surgery. A physical exam will be performed at your two-week appointment to check how your incision is healing.	Behavioral: Standard Restrictions; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urogenital Distress Inventory	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	3 months and 1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	All adverse events will be recorded for both groups	Primarily 3 months, will offer 1 year survey follow up
Self-reported activity	Using the Rapid Assessment of Physical Activity questionnaire, we will compare groups to assess if activity levels were different between the groups	2 weeks and 3 months postoperatively
Post-operative pain scores	Comparing post-operative pain scores at 2-weeks and 3-months post-operatively using the Numerical Pain Rating Scale from 0-10	2 weeks and 3 months postoperatively
Changes to Sexual Function	The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) will be administered at baseline, 3 months postoperatively and 1 year postoperatively to compare	3 months and 1 year postoperatively
Patient Impression of Improvement	Using the Patient Global Impression of Improvement survey, will assess patient satisfaction and overall improvement	2 weeks, 3 months and 1 year postoperatively

Collaborators and Investigators

• Sponsor: University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stress urinary incontinence; mesh; midurethral sling; postoperative restrictions
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 202407515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No