Stress Urinary IncontinenceNCT02316275
Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery
A study testing No post-operative activity restrictions and Standard post-operative activity restriction in people with Stress Urinary Incontinence, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- No post-operative activity restrictions and Standard post-operative activity restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Anger, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Jennifer Anger, MD, MPH, 310-385-2992
Jennifer Anger, MD, MPH
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- No post-operative activity restrictions, Standard post-operative activity restriction
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No post-operative activity restrictionsOther
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.
Standard post-operative activity restrictionOther
| Study group | Role | What they receive |
|---|---|---|
| Standard post-operative activity restriction | Active comparator | As a traditional method, patients will be restricted from activity for six weeks after sling surgery. Receives: Other: Standard post-operative activity restriction |
| No post-operative activity restrictions | Experimental | Patients are to resume regular activity immediately after mid-urethral sling surgery. Receives: Other: No post-operative activity restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer T. Anger, Cedars-Sinai Medical Center
- Investigators
- Jennifer Anger, MD, MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316275
- Sponsor's protocol ID
- Pro00026474
- Status last verified
- Jul 2018
- First submitted
- 10 Dec 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2618603Herzog 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.
PubMed 2313045Barber 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.
PubMed 21344495Barber 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.
PubMed 16021067Jenkinson 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.
PubMed 9243433Ware 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.
PubMed 8628042Hagstromer 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.
PubMed 16925881Craig 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.
PubMed 12900694Hynes 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.
PubMed 17000387Hamidi 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.
PubMed 19300185Laupacis 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.
PubMed 1306034
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications
- ClinicalTrials.gov ID
- NCT02316275
- Acronym / sponsor ID
- Pro00026474
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard post-operative activity restriction | Active comparator | Other: Standard post-operative activity restrictionAs a traditional method, patients will be restricted from activity for six weeks after sling surgery. |
| No post-operative activity restrictions | Experimental | Other: No post-operative activity restrictionsPatients are to resume regular activity immediately after mid-urethral sling surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No post-operative activity restrictionsPatients 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. | Other | No post-operative activity restrictions |
| Standard post-operative activity restriction | Other | Standard post-operative activity restriction |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 2618603Lose 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.
- Background: PubMed 2313045Herzog 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.
- Background: PubMed 21344495Barber 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.
- Background: PubMed 16021067Barber 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.
- Background: PubMed 9243433Jenkinson 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.
- Background: PubMed 8628042Ware 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.
- Background: PubMed 16925881Hagstromer 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 17000387Hynes 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.
- Background: PubMed 19300185Hamidi 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.
- Background: PubMed 1306034Laupacis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Anger, MD, MPH contact
Jennifer Anger, MD, MPH principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No post-operative activity restrictions and Standard post-operative activity restriction in people with Stress Urinary Incontinence, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Anger, MD, MPH (3103852992), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316275, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.