Postoperative Restrictions for Stress Urinary Incontinence

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Iowa

No Placebo Group

Trial Summary

What is the purpose of this 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.

Research Team

Eligibility Criteria

This trial is for individuals who have undergone a mesh urethral sling placement to treat stress urinary incontinence. Participants will be randomly assigned to follow either standard postoperative restrictions or limited restrictions and will complete surveys over the course of a year.

Inclusion Criteria

I am having a specific surgery for urinary incontinence using synthetic mesh.

Exclusion Criteria

I am undergoing a procedure for organ prolapse.

Non-English speaking

Incarcerated

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Treatment Details

Interventions

Limited Restrictions (Behavioral Intervention)
Standard Restrictions (Behavioral Intervention)

Trial OverviewThe study aims to compare the outcomes of two different sets of postoperative instructions: one with standard activity and lifting limitations, and another with fewer restrictions following sling surgery for urinary incontinence.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Limited RestrictionsExperimental Treatment1 Intervention

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.

Group II: Standard RestrictionsActive Control1 Intervention

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.