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Exercise After Mid-Urethral Sling Surgery for Stress Urinary Incontinence
N/A
Recruiting
Led By Jennifer Anger, MD, MPH
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-pregnant female
Self-reported stress urinary incontinence
Must not have
Concomitant prolapse surgery other than anterior colporrhaphy
Age <18 years at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will help determine if unrestricted activity following surgery for stress urinary incontinence has an impact on continence outcomes long term.
Who is the study for?
This trial is for non-pregnant women with stress urinary incontinence who are planning to have mid-urethral sling surgery. They must be able to follow up for 2 years, complete study tasks, and provide consent. Women under 18, currently pregnant or less than a year post-partum, or unable to understand English can't join.
What is being tested?
The study is testing the effects of not restricting activities after mid-urethral sling surgery against standard activity restrictions. It aims to see how this affects continence outcomes over time and when patients naturally return to their usual activities.
What are the potential side effects?
Since the interventions involve different levels of physical activity rather than medication, side effects may include discomfort or complications related to increased activity post-surgery versus potential benefits from a quicker return to normal activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant.
Select...
I experience urine leakage when I cough, sneeze, or exercise.
Select...
I am scheduled for a surgery to support my urethra.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am having or have had surgery for prolapse, but not anterior colporrhaphy.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: No post-operative activity restrictionsExperimental Treatment1 Intervention
Patients are to resume regular activity immediately after mid-urethral sling surgery.
Group II: Standard post-operative activity restrictionActive Control1 Intervention
As a traditional method, patients will be restricted from activity for six weeks after sling surgery.
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
513 Previous Clinical Trials
163,339 Total Patients Enrolled
Jennifer Anger, MD, MPHPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having or have had surgery for prolapse, but not anterior colporrhaphy.You have trouble controlling your bladder, as shown by a physical exam or a special test.I am under 18 years old.I am not pregnant.I experience urine leakage when I cough, sneeze, or exercise.I am scheduled for a surgery to support my urethra.
Research Study Groups:
This trial has the following groups:- Group 1: Standard post-operative activity restriction
- Group 2: No post-operative activity restrictions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.