Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery
Primary Purpose
Stress Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No post-operative activity restrictions
Standard post-operative activity restriction
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard post-operative activity restriction
No post-operative activity restrictions
Arm Description
As a traditional method, patients will be restricted from activity for six weeks after sling surgery.
Patients are to resume regular activity immediately after mid-urethral sling surgery.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02316275
First Posted
December 10, 2014
Last Updated
July 17, 2018
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02316275
Brief Title
Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery
Official Title
IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard post-operative activity restriction
Arm Type
Active Comparator
Arm Description
As a traditional method, patients will be restricted from activity for six weeks after sling surgery.
Arm Title
No post-operative activity restrictions
Arm Type
Experimental
Arm Description
Patients are to resume regular activity immediately after mid-urethral sling surgery.
Intervention Type
Other
Intervention Name(s)
No post-operative activity restrictions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard post-operative activity restriction
Primary Outcome Measure Information:
Title
Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.
Description
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).
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Anger, MD, MPH
Phone
3103852992
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
Phone
310-385-2992
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
12. IPD Sharing Statement
Citations:
PubMed Identifier
2618603
Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery
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