Trial Outcomes & Findings for Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test (NCT 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

137 participants

Primary outcome timeframe

Immediately after the examination

Results posted on

2011-09-13

Participant Flow

Participant milestones

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

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=5 Participants	57.1 years STANDARD_DEVIATION 12.9 • n=7 Participants	58.5 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	68 Participants n=7 Participants	137 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 White	61 participants n=5 Participants	62 participants n=7 Participants	123 participants n=5 Participants
Race/Ethnicity, Customized Other	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	68 participants n=7 Participants	137 participants n=5 Participants
Parity	2.7 Previous Live Births STANDARD_DEVIATION 1.5 • n=5 Participants	2.6 Previous Live Births STANDARD_DEVIATION 1.5 • n=7 Participants	2.7 Previous Live Births STANDARD_DEVIATION 1.5 • n=5 Participants
Previous Vaginal Births	2.4 Previous Vaginal Births STANDARD_DEVIATION 1.6 • n=5 Participants	2.4 Previous Vaginal Births STANDARD_DEVIATION 1.5 • n=7 Participants	2.4 Previous Vaginal Births STANDARD_DEVIATION 1.5 • n=5 Participants
Body Mass Index (BMI)	29.3 kg/m^2 STANDARD_DEVIATION 8.6 • n=5 Participants	29.1 kg/m^2 STANDARD_DEVIATION 7.8 • n=7 Participants	29.2 kg/m^2 STANDARD_DEVIATION 8.2 • n=5 Participants
Diabetes Yes	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Diabetes No	63 Participants n=5 Participants	56 Participants n=7 Participants	119 Participants n=5 Participants
Vaginal Atrophy Yes	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Vaginal Atrophy No	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Neurological Impairment Yes	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Neurological Impairment No	64 Participants n=5 Participants	62 Participants n=7 Participants	126 Participants n=5 Participants
Current Estrogen Use Yes	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Current Estrogen Use No	61 participants n=5 Participants	62 participants n=7 Participants	123 participants n=5 Participants
Examination Anxiety Yes	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Examination Anxiety No	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Indication for the Visit Urinary Incontinence	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants
Indication for the Visit Pelvic Organ Prolapse	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants
Indication for the Visit Both	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Indication for the Visit Missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the examination

Population: All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Oz Harmanli, MD

Baystate Medical Center

Phone: 4137945608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place