- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343784
Assessment of Voiding After Sling (AVAS)
Assessment of Voiding After Sling (AVAS): A Randomized Trial of Two Methods of Post-operative Catheter Management After Midurethral Sling for Female Stress Urinary Incontinence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Beachwood, Ohio, United States, 44122
- Cleveland Clinic Beachwood
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Mayfield Heights, Ohio, United States, 44124
- Cleveland Clinic Hillcrest Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Enrollment:
All patients,18-81 year old, undergoing an outpatient midurethral sling surgery will be screened for participation in the study at the preoperative visit.
Exclusion:
- Women undergoing concomitant urinary tract or pelvic reconstructive procedures
- Women with pelvic organ prolapse beyond the hymen
- Women who have undergone a different or same procedure for urinary incontinence in the past
- Women with neurological conditions, such as multiple sclerosis, spinal cord injury/pathology
- Cases complicated by a cystotomy or other complication necessitating postoperative catheterization
- Non-English speakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Voiding Trial
Subjects in this group will undergo backfill-assisted voiding trial that involves infusing 300ml of fluid in the bladder, removing the catheter and allowing the patient to void.
All subjects will be asked to use visual analog scale (VAS) to assess their force of stream (FOS) and the voided amount as well as post-void residual (PVR) (measured by the bladder ultrasound) will be measured and recorded.
Subjects will be discharged without a catheter if the voided amount is more than 200ml, or 2/3rds of the infused volume (300ml).
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Both groups will undergo voiding trial in the similar manner.
The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).
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Experimental: Force of Stream Voiding Trial
Subjects in this group will undergo backfill-assisted voiding trial that involves infusing 300ml of fluid in the bladder, removing the catheter and allowing the patient to void.
All subjects will be asked to use visual analog scale (VAS) to assess their force of stream (FOS) and the voided amount as well as post-void residual (PVR) (measured by the bladder ultrasound) will be measured and recorded.
Subjects in the FOS group will be discharged home without a catheter if they are able to void any amount and report an FOS of at least 50% their typical FOS based on a visual analog scale
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Both groups will undergo voiding trial in the similar manner.
The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Catheterization Rate
Time Frame: Surgery to 6-weeks post-operatively
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The incidence of postoperative catheterization (total catheterization) at any point from discharge after surgery to 6 weeks postoperatively. The incidence of being discharged with an indwelling catheter will be gathered from PACU records. The information regarding catheterization after that point will be captured via the electronic medical records or patient questionnaires (at 2 days, 1 week, and 6 week follow-up). |
Surgery to 6-weeks post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective assessment of Force of Stream (FOS).
Time Frame: 30 minutes to 2 hours in recovery room
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Using VAS, the subject compares the post-operative FOS with the pre-operative FOS on a scale of 0-120% given the pre-operative FOS is 100%.
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30 minutes to 2 hours in recovery room
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Number of return visits to the office or to the emergency room
Time Frame: 6 weeks
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This information will be captured via the EMR or the patient questionnaires, at 2-days, 1-week and 6-weeks folow-up.
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6 weeks
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Cumulative number of days of catheterization
Time Frame: 6 weeks
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Calculated from EMR at the 6-weeks post-operative visit.
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6 weeks
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Incidence of catheter acquired urinary tract infection (CAUTI)
Time Frame: 6 weeks
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UTI is defined according to the CDC as a positive culture >10^5 CFU/ml with no more than 2 species of microorganisms in the patient's endorsing 1 or more UTI symptoms.
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6 weeks
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Time to discharge from PACU
Time Frame: 30 minutes to 2 hours in recovery room
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Collected from EMR.
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30 minutes to 2 hours in recovery room
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Effectiveness of the sling procedure
Time Frame: 6 weeks
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Incontinence severity index will be collected at enrollment and at 6 weeks post surgery.
The score will be compared to determine if the procedure was effective at treating incontinence.
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6 weeks
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Postoperative pain
Time Frame: 6 weeks
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Pain scale will be administered at 2-days, 1-week and 6-weeks follow-up.
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6 weeks
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Patient's expectation of postoperative recovery
Time Frame: Assessed at enrollment, average 10 minutes
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Information will be collected via short survey at enrollment.
The subject will be asked to assign a level of importance to post-operative factors such as pain control, prolonged catheterization, daily activities and ability to return to work.
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Assessed at enrollment, average 10 minutes
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Daily function postoperatively as well as satisfaction with the surgery
Time Frame: 6 weeks
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Information will be gathered from questionnaires at 2-days, 1-week and 6-weeks follow-up.
Modified validated questionnaire will be used (McCarthy et al).
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Eric Jelovsek, MD, The Cleveland Clinic
- Study Director: Matthew Barber, MD, MHS, The Cleveland Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB 11-082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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