Trial Outcomes & Findings for Effect of Urethral Analgesia on Voiding (NCT NCT02823431)

NCT ID: NCT02823431

Last Updated: 2018-07-27

Results Overview

voided volume/{voided volume + residual volume} during micturition study during urodynamic studies

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: duration of urodynamic study, 2 hours
• Results posted on: 2018-07-27

Participant Flow

Participant milestones

Measure	Analgesia Arm Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia). lidocaine gel	Placebo Arm Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed. Plain aqueous gel
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Urethral Analgesia on Voiding

Baseline characteristics by cohort

Measure	Analgesia Arm n=11 Participants Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia). lidocaine gel	Placebo Arm n=12 Participants Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed. Plain aqueous gel	Total n=23 Participants Total of all reporting groups
Age, Continuous	30 years STANDARD_DEVIATION 9.6 • n=5 Participants	33 years STANDARD_DEVIATION 9.2 • n=7 Participants	31.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
BMI	23 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	25 kg/m^2 STANDARD_DEVIATION 5 • n=7 Participants	24 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: duration of urodynamic study, 2 hours

voided volume/{voided volume + residual volume} during micturition study during urodynamic studies

Outcome measures

Measure	Analgesia Arm n=11 Participants Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia). lidocaine gel	Placebo Arm n=12 Participants Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed. Plain aqueous gel
Voiding Efficiency	87 Percent voiding efficiency Standard Deviation 8	90 Percent voiding efficiency Standard Deviation 5

SECONDARY outcome

Timeframe: duration of urodynamic study, 2 hours

bladder pressure reading (mmHg) during maximum flow during micturition

Outcome measures

Measure	Analgesia Arm n=11 Participants Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia). lidocaine gel	Placebo Arm n=12 Participants Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed. Plain aqueous gel
Detrusor Pressure at Maximum Flow	37.6 cmH2O Standard Deviation 19.2	31 cmH2O Standard Deviation 18.9

SECONDARY outcome

Timeframe: duration of urodynamic study, 2 hours

presence of interrupted flow during micturition

Outcome measures

Measure	Analgesia Arm n=11 Participants Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia). lidocaine gel	Placebo Arm n=12 Participants Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed. Plain aqueous gel
Number of Participants With Interrupted Urinary Flow Pattern During Micturition	4 Participants	0 Participants

SECONDARY outcome

Timeframe: duration of urodynamic study, 2 hours

visual analog scales were performed to evaluate discomfort at specified time points during the urodynamic studies. The scale is 1-100mm, with higher numbers indicating greater discomfort.

Outcome measures

Measure	Analgesia Arm n=11 Participants Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia). lidocaine gel	Placebo Arm n=12 Participants Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed. Plain aqueous gel
Visual Analog Scale Scores (Measure of Discomfort) After Catheterization	26 mm Standard Deviation 20	19 mm Standard Deviation 21

Adverse Events

Analgesia Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Arm

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

Warren Grill PhD

Duke Biomedical Engineering

Phone: (919) 660-5276

Email: warren.grill@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place