Stress Urinary Incontinence
Conditions
Brief summary
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.
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.
Interventions
OTHERNo 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.
OTHERStandard post-operative activity restriction
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment. | 2 years | Return to normal activity immediately after mid-urethral sling surgery could result in faster return to baseline health-related quality of life. Each questionnaire will be administered weekly following surgery until the patient returns to within 10% of baseline scores. Cost-effectiveness of early return to normal activity via Productivity Loss form as time spent recovering from surgery will be analyzed (incremental cost effectiveness ratio of net means by comparing the unrestricted and restricted groups). |
Countries
United States
Contacts
Primary ContactJennifer Anger, MD, MPH
Outcome results
None listed