Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

Study Overview
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Brief Summary
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To determine the impact of unrestricted postoperative activity on intermediate- and long-term continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence. To assess the natural return to baseline activity level when patients are unrestricted following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic organ prolapse repair.

Detailed Description
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Over the last decade, the mid-urethral sling has become the new gold standard in the management of stress urinary incontinence because of its high success rate and minimally invasive nature. However, postoperative management has not kept pace with the modernization of sling surgery. Although formal guidelines regarding the resumption of normal activity levels have not been established, it is general practice to restrict exercise for a minimum of six weeks after surgery. For the study, if immediate resumption of normal activity has no impact on intermediate- and long-term continence outcomes, it may result in improved quality of life and cost savings from a societal perspective.

Official Title
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IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Other: No post-operative activity restrictions
* Other: Standard post-operative activity restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pregnant female Self-reported stress urinary incontinence Incontinence demonstrated on physical exam and/or by an urodynamics study Planned mid-urethral sling surgery Available for 2 years of follow-up Willing and able to complete study assessments per the judgment of the treating clinician Willing and able to provide written informed consent Exclusion Criteria: Age <18 years at time of enrollment Concomitant prolapse surgery other than anterior colporrhaphy Currently pregnant or <12 months post-partum Unable to read, write, or comprehend English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard post-operative activity restriction<br>As a traditional method, patients will be restricted from activity for six weeks after sling surgery. | Other: Standard post-operative activity restriction<br> <br> |
| Experimental: No post-operative activity restrictions<br>Patients are to resume regular activity immediately after mid-urethral sling surgery. | Other: No post-operative activity restrictions<br>* Patients are to resume regular activity immediately after mid-urethral sling surgery. The investigators will determine the impact of unrestricted post-operative activity on continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence (SUI). Investigators will measure the effect of unrestricted post-operative activity on early health-related quality of life (HRQOL). A Productivity Loss form for cost-effective analysis will be asked of the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment. | Return to normal activity immediately after mid-urethral sling surgery could result in faster return to baseline health-related quality of life. Each questionnaire will be administered weekly following surgery until the patient returns to within 10% of baseline scores. Cost-effectiveness of early return to normal activity via Productivity Loss form as time spent recovering from surgery will be analyzed (incremental cost effectiveness ratio of net means by comparing the unrestricted and restricted groups). | 2 years |