Assessment of Voiding After Sling

Post-operative Voiding Clinical Trial

— AVAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343784
• Other study ID #: IRB 11-082
• Status: Completed
• Phase: N/A
• First received: April 26, 2011
• Last updated: February 18, 2014
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 81 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Post-operative Voiding

Intervention

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).

Locations

Country	Name	City	State
United States	Cleveland Clinic Beachwood	Beachwood	Ohio
United States	Cleveland Clinic Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Catheterization Rate	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	Yes
Secondary	Subjective assessment of Force of Stream (FOS).	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%.	30 minutes to 2 hours in recovery room	No
Secondary	Number of return visits to the office or to the emergency room	This information will be captured via the EMR or the patient questionnaires, at 2-days, 1-week and 6-weeks folow-up.	6 weeks	Yes
Secondary	Cumulative number of days of catheterization	Calculated from EMR at the 6-weeks post-operative visit.	6 weeks	Yes
Secondary	Incidence of catheter acquired urinary tract infection (CAUTI)	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.	6 weeks	Yes
Secondary	Time to discharge from PACU	Collected from EMR.	30 minutes to 2 hours in recovery room	No
Secondary	Effectiveness of the sling procedure	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.	6 weeks	No
Secondary	Postoperative pain	Pain scale will be administered at 2-days, 1-week and 6-weeks follow-up.	6 weeks	No
Secondary	Patient's expectation of postoperative recovery	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.	Assessed at enrollment, average 10 minutes	No
Secondary	Daily function postoperatively as well as satisfaction with the surgery	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).	6 weeks	No