N/A
N=90
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01583166 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling — 31; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine (Drug); Saline (Drug); Epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling |
31; 32 | — |
| SECONDARY Post-operative Pain Scores at 2-3 Hours Post op |
3; 2.9 | 0.837 |
| SECONDARY Post-operative Pain Scale at 6-7 Hours Post op |
3.1; 4.1 | — |
| SECONDARY Visual Analog Scale for Pain: Pre-operative. |
0.0; 0.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01583166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.