Clinical trial NCT01343784: Assessment of Voiding After Sling
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Voiding
Keywords: Voiding trial
sling
post-operative assessment
urinary retention
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Catheterization Rate
timeFrame: Surgery to 6-weeks post-operatively
Secondary outcomes:
measure: Subjective assessment of Force of Stream (FOS).
timeFrame: 30 minutes to 2 hours in recovery room
measure: Number of return visits to the office or to the emergency room
timeFrame: 6 weeks
measure: Cumulative number of days of catheterization
timeFrame: 6 weeks
measure: Incidence of catheter acquired urinary tract infection (CAUTI)
timeFrame: 6 weeks
measure: Time to discharge from PACU
timeFrame: 30 minutes to 2 hours in recovery room
measure: Effectiveness of the sling procedure
timeFrame: 6 weeks
measure: Postoperative pain
timeFrame: 6 weeks
measure: Patient's expectation of postoperative recovery
timeFrame: Assessed at enrollment, average 10 minutes
measure: Daily function postoperatively as well as satisfaction with the surgery
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beachwood
country: United States
facility: Cleveland Clinic Beachwood
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic Hillcrest Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: John Eric Jelovsek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Matthew Barber, MD, MHS
role: STUDY_DIRECTOR
References:
citation: Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.