Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT02316275
Status
Recruiting
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Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No post-operative activity restrictions — OTHER
    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.
  • Standard post-operative activity restriction — OTHER

Study Details

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.

Key Dates

Start date
Dec 31, 2011
Status verified
Jul 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment. [ Time Frame: 2 years ]

Central Contacts

  • Jennifer Anger, MD, MPH
    3103852992

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterBeverly HillsCalifornia90211
Jennifer Anger, MD, MPH
310-385-2992
Jennifer Anger, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Beverly Hills, CA

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