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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
Locations
United States
Iowa
University of Iowa Health Care
RECRUITING
Iowa City
Contact Information
Primary
Leanne Brechtel, MD
leanne-brechtel@uiowa.edu
+1 319 356 2294
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 84
Treatments
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.
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.
Sponsors
Leads: University of Iowa

This content was sourced from clinicaltrials.gov