Assessment of Voiding After Sling



Status:Recruiting
Conditions:Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 81
Updated:3/1/2014
Start Date:April 2011
Contact:Geetha Krishnan, RN
Email:krishng@ccf.org
Phone:216-445-8090

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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

The purpose of this study is to compare the incidence of catheterization from discharge to 6
weeks postoperatively when using two methods of post-operative voiding evaluation after a
mid-urethral sling procedure. The investigators' results may lead to a decreased use of
indwelling catheters and their associated morbidity after outpatient sling surgery.

Minimally invasive slings have demonstrated similar efficacy to earlier abdominal
anti-incontinence procedures, but offer the benefit of shorter operating times, less voiding
dysfunction, lower morbidity and are usually done as an outpatient procedure. Despite the
advantages, about 35% of patients are discharged home with indwelling catheters. Indwelling
catheters are bothersome for patients, costly to the healthcare system and are a source of
significant morbidity. The challenge for pelvic surgeons performing anti-incontinence
procedures is avoiding postoperative urinary retention while minimizing the use of catheters
and their associated risks. A commonly described backfill-assisted voiding trial is used as
a means of evaluating bladder function postoperatively. This method uses a low post-void
residual as a specific criterion for discharge without a catheter. However, the validity of
this method has never been critically evaluated. Our recent observational study suggests
that patients may be safely discharged without a catheter after a midurethral sling
procedure based on their subjective assessment of the force of stream. Our proposed study
expands on this pilot data using a randomized trial to evaluate two methods of
post-operative voiding evaluation. The results may lead to a decreased use of indwelling
catheters and their associated morbidity after outpatient sling surgery.

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:

1. Women undergoing concomitant urinary tract or pelvic reconstructive procedures

2. Women with pelvic organ prolapse beyond the hymen

3. Women who have undergone a different or same procedure for urinary incontinence in
the past

4. Women with neurological conditions, such as multiple sclerosis, spinal cord
injury/pathology

5. Cases complicated by a cystotomy or other complication necessitating postoperative
catheterization

6. Non-English speakers
We found this trial at
2
sites
Mayfield Heights, Ohio 44124
134
mi
from 43215
Mayfield Heights, OH
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Beachwood, Ohio 44122
131
mi
from 43215
Beachwood, OH
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