Trial Outcomes & Findings for Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test (NCT NCT00883103)
NCT ID: NCT00883103
Last Updated: 2011-09-13
Results Overview
A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.
COMPLETED
PHASE4
137 participants
Immediately after the examination
2011-09-13
Participant Flow
Participant milestones
| Measure |
Lidocaine Gel
2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
|
Placebo
Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
68
|
|
Overall Study
COMPLETED
|
69
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test
Baseline characteristics by cohort
| Measure |
Lidocaine Gel
n=69 Participants
2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
|
Placebo
n=68 Participants
Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.9 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
57.1 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
58.5 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
61 participants
n=99 Participants
|
62 participants
n=107 Participants
|
123 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=99 Participants
|
68 participants
n=107 Participants
|
137 participants
n=206 Participants
|
|
Parity
|
2.7 Previous Live Births
STANDARD_DEVIATION 1.5 • n=99 Participants
|
2.6 Previous Live Births
STANDARD_DEVIATION 1.5 • n=107 Participants
|
2.7 Previous Live Births
STANDARD_DEVIATION 1.5 • n=206 Participants
|
|
Previous Vaginal Births
|
2.4 Previous Vaginal Births
STANDARD_DEVIATION 1.6 • n=99 Participants
|
2.4 Previous Vaginal Births
STANDARD_DEVIATION 1.5 • n=107 Participants
|
2.4 Previous Vaginal Births
STANDARD_DEVIATION 1.5 • n=206 Participants
|
|
Body Mass Index (BMI)
|
29.3 kg/m^2
STANDARD_DEVIATION 8.6 • n=99 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 7.8 • n=107 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Diabetes
Yes
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Diabetes
No
|
63 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Vaginal Atrophy
Yes
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Vaginal Atrophy
No
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Neurological Impairment
Yes
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Neurological Impairment
No
|
64 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Current Estrogen Use
Yes
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Current Estrogen Use
No
|
61 participants
n=99 Participants
|
62 participants
n=107 Participants
|
123 participants
n=206 Participants
|
|
Examination Anxiety
Yes
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Examination Anxiety
No
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Indication for the Visit
Urinary Incontinence
|
35 participants
n=99 Participants
|
32 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Indication for the Visit
Pelvic Organ Prolapse
|
18 participants
n=99 Participants
|
22 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Indication for the Visit
Both
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Indication for the Visit
Missing
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately after the examinationPopulation: All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.
A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.
Outcome measures
| Measure |
Lidocaine
n=69 Participants
Lidocaine gel was applied to the Q-tip and the catheter before insertion.
|
Aqueous Gel
n=68 Participants
Aqueous gel was applied to the Q-tip and the catheter before insertion.
|
|---|---|---|
|
Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain
|
1 Scores on a scale
Full Range number • Interval 0.0 to 5.0
|
2 Scores on a scale
Interval 0.0 to 4.0
|
Adverse Events
Lidocaine Gel
Placebo
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