- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552457
Postoperative Activity Restrictions After Slings (PARS)
Do Liberal Versus Strict Postoperative Restrictions After Mid-urethral Slings Affect Outcomes?
Postoperative restrictions are often based on expert opinion and "common sense". There is a wide variety in the recommended activity limitation amongst pelvic floor surgeons. Many patients undergo urogynecologic procedures to improve their quality of life, and these additional restrictions decrease their quality of life in the short term. Our hypothesis is that unrestricted activity after a mid-urethral sling will not negatively impact a patient's recovery or likelihood of surgical success.
Eligible participants will be randomized to no postoperative instructions or traditional postoperative instructions. Patients will be followed up at 2 weeks, 6 weeks, and 6 months postoperatively. Data will be collected throughout the follow up period, but the primary endpoint is at 6 months. At the 6 month visit, subjects' activity level, leakage symptoms, and postoperative satisfaction will be assessed.
Study Overview
Status
Intervention / Treatment
Detailed Description
There is a limited body of literature regarding restrictions for gynecologic surgery. Most of these studies have looked at patients with prolapse and incontinence, and many of the postoperative recommendations are intended for both classes of procedures. Most surgeons restrict their patients' activities postoperatively but to varying degrees and for variable amounts of time. One study in 2017 showed no adverse effect on short term outcomes after prolapse repair with liberal postoperative restrictions compared to stricter, traditional restrictions. No studies have been performed to look at postoperative restrictions after mid-urethral slings.
A common reason for limiting activity is due to the unproven concern about increased intra-abdominal pressure on healing and surgical success. At this time, no studies have shown causality. The range of intra-abdominal pressures generated during "unavoidable" activities, such as coughing, standing, and bending, overlaps with the range of pressures generated during activities that are typically restricted. Another study showed the intra-abdominal pressures generated during activities of daily living overlapped with pressures generated by women performing CrossFit exercises.
A 2017 study showed no effect on outcomes with unrestricted activity after pelvic reconstructive surgery. Orthopedic literature suggests better outcomes with early postoperative activity over immobilization. There is a significant body of literature showing potential detrimental effects of sedentary behavior and bed rest.
In 2010, an estimated 28.1 million women had urinary incontinence; however only 260,000 sling surgeries were performed that year. As stress urinary incontinence is primarily thought to result from a loss of support for the urethra, anatomic repair key to its treatment. Many women delay any type of treatment for stress urinary incontinence due to lack of awareness or belief in the myth that stress incontinence is a "normal part of aging". The arbitrary activity restrictions serve as yet another obstacle to treatment, especially for women who work as physical laborers. Since these activity restrictions are rooted in medical dogma and there is no evidence supporting the necessity of postoperative activity restrictions, this is a significant, iatrogenic barrier to care for all women with stress urinary incontinence. Our study could provide objective evidence of the effects of activity on satisfaction and surgical success after mid-urethral slings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Great Neck, New York, United States, 11030
- North Shore University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-85 years
- Urodynamic-proven stress incontinence or stress leakage on physical exam
- Desires surgical management for stress incontinence with a midurethral sling
Exclusion Criteria:
- Prior midurethral sling or urethropexy
- Prior pelvic reconstruction
- Prior pelvic radiation
- Connective tissue disorder
- Severe physical limitation at baseline
- Currently pregnant or desires future childbearing potential
- Concomitant surgeries (except for anterior colporrhaphy for anterior wall prolapse less than 0 on POPQ or other minor procedures).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: No activity restrictions
|
Patients in the "No activity restrictions" group will be allowed to return to their normal activity immediately.
|
ACTIVE_COMPARATOR: Activity restrictions
|
Patients in the "Activity restrictions" group will not be allowed to perform strenuous exercise or lift anything greater than 10lbs.
"Strenuous exercise" will be defined as is any activity that requires so much exertion that one cannot have a conversation comfortably while doing it.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction with postoperative course
Time Frame: 6 months
|
5-point scale with minimum of 1 and maximum of 5 points, higher scores corresponding to more satisfaction
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical success
Time Frame: 6 months
|
Presence of persistent or recurrent stress urinary incontinence as defined as positive cough stress test and positive response on Urogenital Distress Inventory short form.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gephart LF, Doersch KM, Reyes M, Kuehl TJ, Danford JM. Intraabdominal pressure in women during CrossFit exercises and the effect of age and parity. Proc (Bayl Univ Med Cent). 2018 Apr 9;31(3):289-293. doi: 10.1080/08998280.2018.1446888. eCollection 2018 Jul.
- Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
- Weir LF, Nygaard IE, Wilken J, Brandt D, Janz KF. Postoperative activity restrictions: any evidence? Obstet Gynecol. 2006 Feb;107(2 Pt 1):305-9. doi: 10.1097/01.AOG.0000197069.57873.d6.
- McCormack R, Bovard J. Early functional rehabilitation or cast immobilisation for the postoperative management of acute Achilles tendon rupture? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2015 Oct;49(20):1329-35. doi: 10.1136/bjsports-2015-094935. Epub 2015 Aug 17.
- Nygaard IE, Hamad NM, Shaw JM. Activity restrictions after gynecologic surgery: is there evidence? Int Urogynecol J. 2013 May;24(5):719-24. doi: 10.1007/s00192-012-2026-2. Epub 2013 Jan 23.
- FitzGerald MP, S. S., Shott S, Brubaker L (2001).
- Magon N, Kalra B, Malik S, Chauhan M. Stress urinary incontinence: What, when, why, and then what? J Midlife Health. 2011 Jul;2(2):57-64. doi: 10.4103/0976-7800.92525.
- Murphy M. Restrictions and limitations after pelvic floor surgery: what's the evidence? Curr Opin Obstet Gynecol. 2017 Oct;29(5):349-353. doi: 10.1097/GCO.0000000000000393.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-0141
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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