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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
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
December 10, 2014
Last Updated
July 17, 2018
Sponsor
Cedars-Sinai Medical Center
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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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Results Reference
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PubMed Identifier
2313045
Citation
Herzog AR, Diokno AC, Brown MB, Normolle DP, Brock BM. Two-year incidence, remission, and change patterns of urinary incontinence in noninstitutionalized older adults. J Gerontol. 1990 Mar;45(2):M67-74. doi: 10.1093/geronj/45.2.m67.
Results Reference
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PubMed Identifier
21344495
Citation
Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
Results Reference
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PubMed Identifier
16021067
Citation
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
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PubMed Identifier
9243433
Citation
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PubMed Identifier
8628042
Citation
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PubMed Identifier
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Citation
Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
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Citation
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Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

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