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Post-Operative Activity Restriction Duration for Stress Urinary Incontinence

N/A

Waitlist Available

Led By Oz Harmanli, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence

At least 18 years of age

Must not have

Patients who are unable to read, understand, or complete study documents in English or Spanish

Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 6 months, and 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare outcomes and satisfaction for patients who have different post-operative restrictions following a midurethral sling procedure.

Who is the study for?

This trial is for ambulatory patients at least 18 years old who are scheduled for midurethral sling surgery to treat stress urinary incontinence. Participants must be able to understand and complete study documents in English or Spanish, and commit to not lifting heavy objects (over 20 lbs) for 6 weeks.

What is being tested?

The study compares two different durations of activity restrictions after midurethral sling surgery: one group will have a 3-week restriction, while the other will have a 6-week restriction. The focus is on postoperative outcomes and patient satisfaction.

What are the potential side effects?

Since this trial involves post-surgical care instructions rather than medication, it does not directly test interventions with side effects. However, general surgical risks may include discomfort, infection risk at the incision site, or complications related to reduced activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk and am scheduled for a specific surgery to treat stress urinary incontinence.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read or understand English or Spanish well enough to complete study documents.

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I can avoid heavy lifting (20 lbs) for 6 weeks.

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I am having surgery for pelvic organ prolapse not including a midurethral sling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 6 months, and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 6 months, and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 6 months, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in urogenital distress inventory (UDI) stress score

Secondary study objectives

Activity Assessment Scale (AAS)

Change in Patient Satisfaction Post-Operative Questionnaire

Change in cough stress test

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 6-week post-operative activity restrictionExperimental Treatment1 Intervention

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.

Group II: 3-week post-operative activity restrictionExperimental Treatment1 Intervention

0 / 5Eligibility criteria met