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Postoperative Activity Restrictions After Slings (PARS)

Primary Purpose

Stress Urinary Incontinence, Patient Satisfaction, Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No activity restrictions
Activity restrictions
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Mid-urethral sling, Postoperative activity, Activity restriction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • North Shore University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No activity restrictions

Activity restrictions

Arm Description

Outcomes

Primary Outcome Measures

Patient satisfaction with postoperative course
5-point scale with minimum of 1 and maximum of 5 points, higher scores corresponding to more satisfaction

Secondary Outcome Measures

Surgical success
Presence of persistent or recurrent stress urinary incontinence as defined as positive cough stress test and positive response on Urogenital Distress Inventory short form.

Full Information

First Posted
September 10, 2020
Last Updated
February 2, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04552457
Brief Title
Postoperative Activity Restrictions After Slings
Acronym
PARS
Official Title
Do Liberal Versus Strict Postoperative Restrictions After Mid-urethral Slings Affect Outcomes?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Patient Satisfaction, Surgery
Keywords
Mid-urethral sling, Postoperative activity, Activity restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No activity restrictions
Arm Type
Experimental
Arm Title
Activity restrictions
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
No activity restrictions
Intervention Description
Patients in the "No activity restrictions" group will be allowed to return to their normal activity immediately.
Intervention Type
Behavioral
Intervention Name(s)
Activity restrictions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient satisfaction with postoperative course
Description
5-point scale with minimum of 1 and maximum of 5 points, higher scores corresponding to more satisfaction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surgical success
Description
Presence of persistent or recurrent stress urinary incontinence as defined as positive cough stress test and positive response on Urogenital Distress Inventory short form.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
North Shore University Hospital
City
Great Neck
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29904290
Citation
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.
Results Reference
background
PubMed Identifier
28277355
Citation
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.
Results Reference
background
PubMed Identifier
16449116
Citation
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.
Results Reference
background
PubMed Identifier
26281836
Citation
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.
Results Reference
background
PubMed Identifier
23340879
Citation
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.
Results Reference
background
Citation
FitzGerald MP, S. S., Shott S, Brubaker L (2001).
Results Reference
background
PubMed Identifier
22408333
Citation
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.
Results Reference
background
PubMed Identifier
28719393
Citation
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.
Results Reference
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Postoperative Activity Restrictions After Slings

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