NCT04817839

Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.

Detailed description

This is a blinded, randomized controlled trial. Patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. If eligible and willing to participate, patients will be randomized to a "3 weeks post-operative restriction" or "6-week post-operative restriction" of activities group. Currently, pelvic surgeons' recommendations for activity and lifting restrictions during post-operative period vary widely from 1 to 50 pounds (10). Given variation in literature and reasonable expectations for lifting restrictions, 20-pound lifting restriction was considered to be a reasonable and attainable expectation from patients. Both groups will be given an identical set of postoperative instructions which include refrainment from lifting anything over 20 pounds, avoid strenuous exercise, running, or perform high-impact aerobic activities during the restricted activity period. Depending on their random allocation, patients will follow these instructions either for 3 or 6 postoperative weeks. The activities which all patients will be allowed to do during their postoperative recovery include walking, using stairs and showering in both groups. All patient will be asked to refrain from sexual intercourse for 6 weeks consistent with current routine post op recommendations (6). Other than the time of activity restriction post op (heavy lifting, strenuous exercise, running, high impact exercise), patients will receive identical postoperative instructions otherwise.

Conditions

• Urinary Stress Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	3-week post-operative activity restriction	Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.
BEHAVIORAL	6-week post-operative activity restriction	Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-04-05
• Completion: 2024-12-16
• First posted: 2021-03-26
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States