Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery



Status:Recruiting
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:December 2011
End Date:December 2031
Contact:Jennifer Anger, MD, MPH
Phone:3103852992

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

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.

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.

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
We found this trial at
1
site
Beverly Hills, California 90211
Principal Investigator: Jennifer Anger, MD, MPH
Phone: 310-385-2992
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Beverly Hills, CA
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