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Assessment of Voiding After Sling (AVAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01343784
First received: April 26, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Post-operative Voiding
Other: Urinary voiding assessment after midurethral sling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Total Catheterization Rate [ Time Frame: Surgery to 6-weeks post-operatively ] [ Designated as safety issue: Yes ]

    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).



Secondary Outcome Measures:
  • Subjective assessment of Force of Stream (FOS). [ Time Frame: 30 minutes to 2 hours in recovery room ] [ Designated as safety issue: No ]
    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%.

  • Number of return visits to the office or to the emergency room [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    This information will be captured via the EMR or the patient questionnaires, at 2-days, 1-week and 6-weeks folow-up.

  • Cumulative number of days of catheterization [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Calculated from EMR at the 6-weeks post-operative visit.

  • Incidence of catheter acquired urinary tract infection (CAUTI) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Time to discharge from PACU [ Time Frame: 30 minutes to 2 hours in recovery room ] [ Designated as safety issue: No ]
    Collected from EMR.

  • Effectiveness of the sling procedure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Postoperative pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Pain scale will be administered at 2-days, 1-week and 6-weeks follow-up.

  • Patient's expectation of postoperative recovery [ Time Frame: Assessed at enrollment, average 10 minutes ] [ Designated as safety issue: No ]
    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.

  • Daily function postoperatively as well as satisfaction with the surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 105
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other: Urinary voiding assessment after midurethral sling
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).
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
Other: Urinary voiding assessment after midurethral sling
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).

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

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343784

Locations
United States, Ohio
Cleveland Clinic Beachwood
Beachwood, Ohio, United States, 44122
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: John Eric Jelovsek, MD The Cleveland Clinic
Study Director: Matthew Barber, MD, MHS The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01343784     History of Changes
Other Study ID Numbers: IRB 11-082
Study First Received: April 26, 2011
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Voiding trial
sling
post-operative assessment
urinary retention

ClinicalTrials.gov processed this record on November 20, 2014