Trial Outcomes & Findings for Local Anesthetic Treatments for Overactive Bladder (NCT NCT00427648)
NCT ID: NCT00427648
Last Updated: 2020-03-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-03-06
Participant Flow
Two medical clinic sites were used between January 2007 and March 2011, initially the Evanston Continence Center (Evanston, IL), and subsequently to augment recruitment, North Shore Urogynecology (Lake Forest, IL, added July 2009).
no wash out, no run-in
Participant milestones
| Measure |
1/Active
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
1/Active
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
normal saline
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
did not analyze patients eliminated from study due to protocol deviation and withdrawal due to AE
Baseline characteristics by cohort
| Measure |
1/Active
n=12 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=10 Participants
normal saline
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 11.3 • n=11 Participants • did not analyze patients eliminated from study due to protocol deviation and withdrawal due to AE
|
54.3 years
STANDARD_DEVIATION 18.3 • n=7 Participants • did not analyze patients eliminated from study due to protocol deviation and withdrawal due to AE
|
51.9 years
STANDARD_DEVIATION 14 • n=18 Participants • did not analyze patients eliminated from study due to protocol deviation and withdrawal due to AE
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
10 Participants
n=10 Participants
|
22 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
2 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Race (NIH/OMB)
White
|
8 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
7 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
15 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
0 Participants
n=7 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
1 Participants
n=18 Participants • 3 withdrawal of consents, and 1 patient with AE excluded from analysis
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
10 participants
n=10 Participants
|
22 participants
n=22 Participants
|
|
length of OAB symptoms
|
6.8 years
STANDARD_DEVIATION 10.2 • n=11 Participants • protocol withdrawals = 3 and 1 with AE not included
|
7.7 years
STANDARD_DEVIATION 5.4 • n=7 Participants • protocol withdrawals = 3 and 1 with AE not included
|
7.2 years
STANDARD_DEVIATION 8.5 • n=18 Participants • protocol withdrawals = 3 and 1 with AE not included
|
|
prior anticholinergic use
|
8 Participants
n=11 Participants • 3 withdrawals and 1 AE not included
|
5 Participants
n=7 Participants • 3 withdrawals and 1 AE not included
|
13 Participants
n=18 Participants • 3 withdrawals and 1 AE not included
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: only 16 participants completed this diary
Outcome measures
| Measure |
1/Active
n=10 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=6 Participants
normal saline
|
|---|---|---|
|
Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
|
9.5 voids/day
Interval 6.5 to 12.5
|
9 voids/day
Interval 6.75 to 9.75
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
1/Active
n=7 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=6 Participants
normal saline
|
|---|---|---|
|
Median Number of Daily Voiding Episodes at 12 Months.
|
7 voids/day
Interval 7.0 to 9.0
|
8 voids/day
Interval 7.25 to 9.5
|
SECONDARY outcome
Timeframe: 6 weeksSF-12 physical is an abbreviated version of the SF-36 a widely used, general health care quality of life instrument. Scores range from 0-100, and higher scores are better outcomes.
Outcome measures
| Measure |
1/Active
n=11 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=7 Participants
normal saline
|
|---|---|---|
|
SF-12 Physical at 6 Weeks
|
49 score on scale
Interval 39.0 to 56.0
|
56 score on scale
Interval 41.0 to 58.0
|
SECONDARY outcome
Timeframe: 6 weeksOAB-q SS is a 7 item overactive bladder symptom bother sub scale, ranging from 0-100, higher scores mean worse outcome for bother
Outcome measures
| Measure |
1/Active
n=11 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=7 Participants
normal saline
|
|---|---|---|
|
OAB-q (Symptom Scale) at 6 Weeks
|
15 score on a scale
Interval 11.0 to 36.0
|
28 score on a scale
Interval 19.0 to 45.0
|
SECONDARY outcome
Timeframe: 6 weeksThis is patient overall assessment of change in overactive bladder symptoms after treatment. 0% is no change, 100% is total resolution of symptoms
Outcome measures
| Measure |
1/Active
n=11 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=7 Participants
normal saline
|
|---|---|---|
|
Global Assessment of Change - Frequency at 6 Weeks
|
40 percent improvement
Interval 0.0 to 75.0
|
10 percent improvement
Interval 5.0 to 27.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Not all women completed this measure
NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency
Outcome measures
| Measure |
1/Active
n=11 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=6 Participants
normal saline
|
|---|---|---|
|
Average Weekly NRS for Frequency at 6 Weeks
|
4 score on a 0-10 scale
Interval 3.0 to 6.0
|
4 score on a 0-10 scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Not all women were able to return for cystometry
This is based on retrograde infusion of sterile water into the bladder using a catheter, the maximum tolerated volume serving to define how much distension a woman can tolerate.
Outcome measures
| Measure |
1/Active
n=8 Participants
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=6 Participants
normal saline
|
|---|---|---|
|
Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.
|
316 mL
Interval 250.0 to 488.0
|
275 mL
Interval 200.0 to 325.0
|
Adverse Events
1/Active
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
2/Placebo
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 |
1/Active
n=11 participants at risk
alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate
|
2/Placebo
n=7 participants at risk
normal saline
|
|---|---|---|
|
Renal and urinary disorders
bladder infection
|
27.3%
3/11 • Number of events 3 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
28.6%
2/7 • Number of events 2 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
General disorders
pain in lower abdomen
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Gastrointestinal disorders
nausea
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Reproductive system and breast disorders
pelvic pain
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Renal and urinary disorders
dysuria
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
28.6%
2/7 • Number of events 2 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Renal and urinary disorders
urinary hesitancy
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Nervous system disorders
light headedness
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Nervous system disorders
headache
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
General disorders
sleepiness
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
|
Gastrointestinal disorders
constipation
|
9.1%
1/11 • Number of events 1 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
0.00%
0/7 • 12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place