Postoperative Activity Restrictions After Slings
Condition: Stress Urinary Incontinence; Patient Satisfaction; Surgery
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional

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.
    

Intervention name(s): No activity restrictions; Activity restrictions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients in the "No activity restrictions" group will be allowed to return to their normal activity immediately.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mid-urethral sling; Postoperative activity; Activity restriction