Trial Outcomes & Findings for Lessons on Urethral Lidocaine in Urodynamics (NCT NCT04038099)
NCT ID: NCT04038099
Last Updated: 2023-08-01
Results Overview
Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
Within same visit, approximately 90-120 minutes.
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Water Based Lubricating Jelly
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lessons on Urethral Lidocaine in Urodynamics
Baseline characteristics by cohort
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
60.2 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
61.5 years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 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, non-Hispanic
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
33 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Insurance Type
Private
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Insurance Type
Medicare
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Insurance Type
Self-pay
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Current smoker
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Parous
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Prior surgery for Stress Urinary Incontinence (SUI)
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Prior surgery for prolapse
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Prior hysterectomy
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
>3 UTIs in the past year
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Diabetes
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Stage of most severely prolapsed compartment
Stage 0 or 1
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Stage of most severely prolapsed compartment
Stage 2
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Stage of most severely prolapsed compartment
Stage 3 or 4
|
6 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Detrusor overactivity on UDS #1
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within same visit, approximately 90-120 minutes.Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
First Sensation
|
17 mL
Interval 9.0 to 44.0
|
18 mL
Interval 11.0 to 37.0
|
|
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
First Urge to Void
|
137 mL
Interval 86.0 to 191.0
|
107 mL
Interval 62.0 to 238.0
|
|
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
Strong Urge to Void
|
243 mL
Interval 186.0 to 318.0
|
263 mL
Interval 161.0 to 396.0
|
|
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
Maximum Capacity
|
344 mL
Interval 267.0 to 505.0
|
365 mL
Interval 275.0 to 450.0
|
SECONDARY outcome
Timeframe: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral lidocaine 2% jelly meaningfully impacts pain/discomfort measured by a visual analog scale during cystometry (catheter insertion and at maximum cystometric capacity), during pressure flow study (PFS), and post-procedure.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
Catheter insertion
|
7 mm on a VAS Pain Scale
Interval 2.0 to 17.8
|
4.5 mm on a VAS Pain Scale
Interval 1.0 to 20.2
|
|
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
Maximum capacity
|
8 mm on a VAS Pain Scale
Interval 4.2 to 25.0
|
10 mm on a VAS Pain Scale
Interval 4.0 to 38.0
|
|
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
Pressure flow study
|
7 mm on a VAS Pain Scale
Interval 2.0 to 18.0
|
3 mm on a VAS Pain Scale
Interval 0.0 to 8.0
|
|
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
Overall participant discomfort
|
9 mm on a VAS Pain Scale
Interval 2.0 to 21.0
|
4 mm on a VAS Pain Scale
Interval 2.0 to 16.0
|
SECONDARY outcome
Timeframe: Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts provider perception of patient discomfort.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Provider Perception of Patient Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst Pain Imaginable).
|
9 mm on a VAS Pain Scale
Interval 2.0 to 27.0
|
6 mm on a VAS Pain Scale
Interval 2.0 to 16.0
|
SECONDARY outcome
Timeframe: Cystometrogram 2 within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts the presence/absence of detrusor overactivity (bladder spasm) during urodynamic bladder testing. Detrusor overactivity was noted and compared between placebo and lidocaine jelly on UDS #2.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Filling Metrics: Number of Participants With Detrusor Overactivity
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within same visit, approximately 90-120 minutes.Population: \*There were 3 missing data values in our data.
Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts bladder compliance (change in volume/ change in detrusor pressure (Pdet)). Compliance in UDS #2 was noted and compared in both groups: water-based lubricant and intraurethral 2% lidocaine jelly. Results indicate how many participants in which normal compliance was observed. \*There were 3 missing data values in our data.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=28 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=32 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Filling Metrics: Number of Participants With Normal Bladder Compliance
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec).
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Voiding Metrics: Maximum Flow Rate
|
18.2 mL/sec
Interval 11.6 to 25.4
|
16.5 mL/sec
Interval 11.8 to 22.2
|
SECONDARY outcome
Timeframe: within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding pattern. Voiding pattern was assessed in UDS #2 and identified as either "normal", "prolonged", "intermittent", "interrupted" or a combination of those identifiers and compared between the two groups.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.
Intermittent
|
15 Participants
|
21 Participants
|
|
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.
Interrupted
|
14 Participants
|
18 Participants
|
|
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.
Prolonged
|
17 Participants
|
24 Participants
|
|
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.
Normal
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voided volume and post-void residual (mL) as recorded during UDS #2.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Voiding Metrics: Voided Volume and Post-void Residual
Voided Volume
|
278 mL
Interval 174.0 to 400.0
|
318 mL
Interval 225.0 to 402.0
|
|
Voiding Metrics: Voided Volume and Post-void Residual
Post Void Residual
|
29 mL
Interval 0.0 to 61.0
|
15 mL
Interval 0.0 to 66.0
|
SECONDARY outcome
Timeframe: Cystometrogram 2 within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding efficiency, which is calculated as the voided volume (mL) divided by the sum of the voided volume (mL) and the post-void residual volume (mL). Voiding efficiency was compared by treatment arm in UDS #2.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Voiding Metrics: Percentage of Voiding Efficiency
|
94.6 percentage of voiding efficiency
Interval 72.2 to 100.0
|
95.9 percentage of voiding efficiency
Interval 82.3 to 100.0
|
SECONDARY outcome
Timeframe: Within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Voiding Metrics: Pdet Max
|
37 cm/H2O
Interval 26.5 to 46.0
|
28.5 cm/H2O
Interval 20.0 to 46.8
|
SECONDARY outcome
Timeframe: Within same visit, approximately 90-120 minutes.Determine whether the use of intraurethral 2\& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2.
Outcome measures
| Measure |
Water Based Lubricating Jelly
n=30 Participants
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 Participants
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Voiding Metrics: Pdet Peak Flow
|
20 cm/H2O
Interval 9.0 to 30.0
|
13 cm/H2O
Interval 7.0 to 18.0
|
Adverse Events
Water Based Lubricating Jelly
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine 2% Jelly
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Water Based Lubricating Jelly
n=30 participants at risk
5ml of Water Based Lubricating Jelly
Water-Based Vaginal Lubricant: 5cc water based jelly applied intraurethral
|
Lidocaine 2% Jelly
n=33 participants at risk
5ml of Lidocaine 2% Jelly
lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
|
|---|---|---|
|
Renal and urinary disorders
asymptomatic bacteuria
|
0.00%
0/30 • Patients undergoing urodynamics were found to have positive urine cultures from sample sent immediately prior to the procedure. Patients were treated only if symptomatic. Treatment included antibiotic medication for 1 week.
There were no deaths, all-cause mortality or serious adverse events. Other adverse events exceeding 5% frequency include asymptomatic bacteuria- presence of bacteria in urine without any urinary tract infection symptoms present.
|
6.1%
2/33 • Number of events 2 • Patients undergoing urodynamics were found to have positive urine cultures from sample sent immediately prior to the procedure. Patients were treated only if symptomatic. Treatment included antibiotic medication for 1 week.
There were no deaths, all-cause mortality or serious adverse events. Other adverse events exceeding 5% frequency include asymptomatic bacteuria- presence of bacteria in urine without any urinary tract infection symptoms present.
|
Additional Information
Christina Hicks, MS, APRN, WHNP-BC, FAUNA
UT Southwestern Medical Center
Phone: 2146453848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place