Trial Outcomes & Findings for Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics (NCT NCT01612156)
NCT ID: NCT01612156
Last Updated: 2015-01-19
Results Overview
Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam. The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
30 minutes after completion of exam
Results posted on
2015-01-19
Participant Flow
Participant milestones
| Measure |
2% Lidocaine Gel
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
|
Water Based Lubricant
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
48
|
|
Overall Study
COMPLETED
|
40
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
2% Lidocaine Gel
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
|
Water Based Lubricant
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
Baseline characteristics by cohort
| Measure |
2% Lidocaine Gel
n=40 Participants
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
|
Water Based Lubricant
n=48 Participants
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latina/Hispanic
|
38 participants
n=5 Participants
|
45 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Caucasian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Language
English
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Language
Spanish
|
35 participants
n=5 Participants
|
38 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Parity
|
3 births
n=5 Participants
|
3 births
n=7 Participants
|
3 births
n=5 Participants
|
|
Body mass index
|
31.1 kg/m2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
30.1 kg/m2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
30.6 kg/m2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after completion of examSubjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam. The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible).
Outcome measures
| Measure |
2% Lidocaine Gel
n=40 Participants
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
|
Water Based Lubricant
n=48 Participants
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
|
|---|---|---|
|
Pain During the Pelvic Floor Examination
Pain at baseline
|
0.4 units on Wong Baker pain scale
Standard Deviation 1.0
|
0.9 units on Wong Baker pain scale
Standard Deviation 2.2
|
|
Pain During the Pelvic Floor Examination
Pain after cotton tipped swab test
|
1.3 units on Wong Baker pain scale
Standard Deviation 1.5
|
3.6 units on Wong Baker pain scale
Standard Deviation 3.2
|
|
Pain During the Pelvic Floor Examination
Pain after placement of urodynamic catheters
|
1.4 units on Wong Baker pain scale
Standard Deviation 1.9
|
3.9 units on Wong Baker pain scale
Standard Deviation 3.0
|
|
Pain During the Pelvic Floor Examination
Pain 30 minutes after study completion
|
0.7 units on Wong Baker pain scale
Standard Deviation 1.2
|
1.2 units on Wong Baker pain scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 30 minutesThe participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.
Outcome measures
| Measure |
2% Lidocaine Gel
n=40 Participants
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
|
Water Based Lubricant
n=48 Participants
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
|
|---|---|---|
|
Embarrassment With Pelvic Floor Examination
|
2 On 5 point Likert scale
Interval 1.0 to 4.0
|
2 On 5 point Likert scale
Interval 1.0 to 5.0
|
Adverse Events
2% Lidocaine Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water Based Lubricant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place