Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery
July 17, 2018 updated by: Jennifer T. Anger, Cedars-Sinai Medical Center
IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Anger, MD, MPH
- Phone Number: 3103852992
Study Locations
-
-
California
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Beverly Hills, California, United States, 90211
- Recruiting
- Cedars-Sinai Medical Center
-
Contact:
- Jennifer Anger, MD, MPH
- Phone Number: 310-385-2992
-
Principal Investigator:
- Jennifer Anger, MD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard post-operative activity restriction
As a traditional method, patients will be restricted from activity for six weeks after sling surgery.
|
|
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Experimental: No post-operative activity restrictions
Patients are to resume regular activity immediately after mid-urethral sling surgery.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.
Time Frame: 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Anger, MD, MPH, Cedars-Sinai Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- 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.
- 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.
- 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.
- Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.
- 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.
- Lose G, Jorgensen L, Thunedborg P. 24-hour home pad weighing test versus 1-hour ward test in the assessment of mild stress incontinence. Acta Obstet Gynecol Scand. 1989;68(3):211-5. doi: 10.3109/00016348909020991.
- Hynes DM, Stroupe KT, Luo P, Giobbie-Hurder A, Reda D, Kraft M, Itani K, Fitzgibbons R, Jonasson O, Neumayer L. Cost effectiveness of laparoscopic versus open mesh hernia operation: results of a Department of Veterans Affairs randomized clinical trial. J Am Coll Surg. 2006 Oct;203(4):447-57. doi: 10.1016/j.jamcollsurg.2006.05.019. Epub 2006 Jul 13.
- Hamidi V, Andersen MH, Oyen O, Mathisen L, Fosse E, Kristiansen IS. Cost effectiveness of open versus laparoscopic living-donor nephrectomy. Transplantation. 2009 Mar 27;87(6):831-8. doi: 10.1097/TP.0b013e318199cfc9.
- Laupacis A, Feeny D, Detsky AS, Tugwell PX. How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ. 1992 Feb 15;146(4):473-81.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2031
Study Registration Dates
First Submitted
December 10, 2014
First Submitted That Met QC Criteria
December 11, 2014
First Posted (Estimate)
December 12, 2014
Study Record Updates
Last Update Posted (Actual)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00026474
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