Trial Outcomes & Findings for Intravesicular Onabotulinumtoxin A in Interstitial Cystitis (NCT NCT02297100)
NCT ID: NCT02297100
Last Updated: 2018-09-05
Results Overview
The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
30 and 90 days post treatment
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
Botox Upper Aspect Trigone
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Baseline characteristics by cohort
| Measure |
Botox Upper Aspect Trigone
n=13 Participants
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
n=14 Participants
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.38 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 12.32 • n=7 Participants
|
47.41 years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 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
|
PRIMARY outcome
Timeframe: 30 and 90 days post treatmentPopulation: One participant was lost to follow-up in the experimental group and no data was collected at 30 days on one participant in the control group.
The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.
Outcome measures
| Measure |
Botox Upper Aspect Trigone
n=12 Participants
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
n=14 Participants
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
|---|---|---|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
Symptoms @ 30 days
|
10.92 units on a scale
Standard Deviation 3.15
|
10.85 units on a scale
Standard Deviation 4.18
|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
Bother @ 30 days
|
9.75 units on a scale
Standard Deviation 4.00
|
9.92 units on a scale
Standard Deviation 4.61
|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
Symptoms @ 90 days
|
10.75 units on a scale
Standard Deviation 3.62
|
12.00 units on a scale
Standard Deviation 4.54
|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
Bother @ 90 days
|
10.17 units on a scale
Standard Deviation 3.16
|
10.29 units on a scale
Standard Deviation 4.07
|
PRIMARY outcome
Timeframe: 30 and 90 days post-treatmentPopulation: One participant from the experimental group was lost to follow-up. Data was not collected at 30 days for bother and symptom for one participant in the control group.
The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
Botox Upper Aspect Trigone
n=12 Participants
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
n=14 Participants
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
|---|---|---|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
Symptoms @ 30 days
|
13.83 units on a scale
Standard Deviation 4.90
|
12.31 units on a scale
Standard Deviation 4.71
|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
Bother @ 30 days
|
7.33 units on a scale
Standard Deviation 2.77
|
7.31 units on a scale
Standard Deviation 3.17
|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
Symptoms @ 90 days
|
13.33 units on a scale
Standard Deviation 4.75
|
13.21 units on a scale
Standard Deviation 4.42
|
|
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
Bother @ 90 days
|
7.25 units on a scale
Standard Deviation 2.83
|
7.5 units on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: 30 days and 90 days post treatmentPopulation: No data was collected for two participants in the experimental group and one participant in the control group at 30 days. No data was collected for one participant in the experimental group at 90 days.
Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
Outcome measures
| Measure |
Botox Upper Aspect Trigone
n=12 Participants
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
n=14 Participants
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
|---|---|---|
|
Change in Patient Performance in Uroflowmetry.
@ 30 days
|
11.82 ml/s
Standard Deviation 5.64
|
9.5 ml/s
Standard Deviation 7.83
|
|
Change in Patient Performance in Uroflowmetry.
@ 90 days
|
12.17 ml/s
Standard Deviation 7366
|
15.5 ml/s
Standard Deviation 11.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days and 90 days post treatmentPopulation: Data was not collected on one participant in the experimental group at 30 and 90 days post treatment. Data was not collected on two individuals at 30 days post treatment in the control group.
Outcome measures
| Measure |
Botox Upper Aspect Trigone
n=12 Participants
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
n=14 Participants
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
|---|---|---|
|
Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.
@ 30 days
|
27.17 mL
Standard Deviation 37.06
|
35.33 mL
Standard Deviation 48.00
|
|
Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.
@ 90 days
|
38.92 mL
Standard Deviation 48.10
|
60.64 mL
Standard Deviation 71.38
|
Adverse Events
Botox Upper Aspect Trigone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Botox Periphery of Trigone
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botox Upper Aspect Trigone
n=13 participants at risk
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
Botox Periphery of Trigone
n=14 participants at risk
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections
injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
|
|---|---|---|
|
Renal and urinary disorders
Painful Voiding
|
0.00%
0/13 • baseline, up to 4 years
|
7.1%
1/14 • baseline, up to 4 years
|
|
Renal and urinary disorders
Urethral Edema
|
7.7%
1/13 • baseline, up to 4 years
|
0.00%
0/14 • baseline, up to 4 years
|
|
Renal and urinary disorders
Urgency
|
7.7%
1/13 • baseline, up to 4 years
|
14.3%
2/14 • baseline, up to 4 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
15.4%
2/13 • baseline, up to 4 years
|
14.3%
2/14 • baseline, up to 4 years
|
|
Renal and urinary disorders
Retention
|
0.00%
0/13 • baseline, up to 4 years
|
14.3%
2/14 • baseline, up to 4 years
|
Additional Information
Dr. Robert Evans
Wake Forest University Health Sciences
Phone: 336-713-0320
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place