Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

Stress Urinary Incontinence Clinical Trial

— URINE&ME  

Official title:

Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583166
• Other study ID #: 14197
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Exclusion Criteria:

• Undergoing procedure in addition to the sling

• Not competent to give consent

• Using intermittent self catheterization pre-operatively

• Known allergy to local anesthetic

• Undergoing spinal anesthesia for the procedure

• Prisoners

• Non-English speaker

• Under 18 years of age

• Has a condition that would contra-indicate the use of local anesthetic or epinephrine

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• Bupivacaine
10ml 0.5% bupivacaine
• Saline
10ml 0.9% sodium chloride
• Epinephrine
1:200,000 epinephrine

Locations

Country	Name	City	State
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling	Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.	2 weeks
Secondary	Post-operative Pain Scores at 2-3 Hours Post op	Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)	2-3 hours
Secondary	Post-operative Pain Scale at 6-7 Hours Post op	Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)	6-7 hours
Secondary	Visual Analog Scale for Pain: Pre-operative.	Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain.	At enrollment