IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Beverly Hills
Contact Information
Primary
Jennifer Anger, MD, MPH
3103852992
Time Frame
Start Date: 2011-12
Estimated Completion Date: 2031-12
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov