Clinical trial NCT04552457: Postoperative Activity Restrictions After Slings
Official title: Do Liberal Versus Strict Postoperative Restrictions After Mid-urethral Slings Affect Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Patient Satisfaction
Surgery
Keywords: Mid-urethral sling
Postoperative activity
Activity restriction
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Patient satisfaction with postoperative course
timeFrame: 6 months
Secondary outcomes:
measure: Surgical success
timeFrame: 6 months
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References:
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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.