Beverly Hills, California 90211


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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02316275


Primary Contact:

Principal Investigator
Jennifer Anger, MD, MPH
Cedars-Sinai Medical Center

Jennifer Anger, MD, MPH
Phone: 3103852992


Backup Contact:

N/A


Location Contact:

Beverly Hills, California 90211
United States

Jennifer Anger, MD, MPH
Phone: 310-385-2992

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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