Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

Purpose

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.

Condition

  • Stress Urinary Incontinence

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard post-operative activity restriction 		As a traditional method, patients will be restricted from activity for six weeks after sling surgery.
  • Other: Standard post-operative activity restriction
Experimental
No post-operative activity restrictions 		Patients are to resume regular activity immediately after mid-urethral sling surgery.
  • Other: No post-operative activity restrictions
    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.

Recruiting Locations

Cedars-Sinai Medical Center
Beverly Hills, California 90211
Contact:
Jennifer Anger, MD, MPH
310-385-2992

More Details

Status
Recruiting
Sponsor
Cedars-Sinai Medical Center

Study Contact

Jennifer Anger, MD, MPH
3103852992

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.