Trial Outcomes & Findings for Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain (NCT NCT02369068)
NCT ID: NCT02369068
Last Updated: 2019-07-24
Results Overview
The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline and One Month
Results posted on
2019-07-24
Participant Flow
Participant milestones
| Measure |
Onabotulinumtoxin A
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
1 Month
STARTED
|
10
|
11
|
|
1 Month
COMPLETED
|
9
|
10
|
|
1 Month
NOT COMPLETED
|
1
|
1
|
|
3 Months
STARTED
|
9
|
10
|
|
3 Months
COMPLETED
|
9
|
8
|
|
3 Months
NOT COMPLETED
|
0
|
2
|
|
6 Months
STARTED
|
9
|
8
|
|
6 Months
COMPLETED
|
9
|
7
|
|
6 Months
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Onabotulinumtoxin A
n=10 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=11 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
46.0 years
STANDARD_DEVIATION 12.8 • n=11 Participants
|
46.2 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
|
Pain Severity
|
5.0 units on a scale
STANDARD_DEVIATION 1.7 • n=10 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.2 • n=11 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.4 • n=21 Participants
|
|
Pain Interference
|
5.9 units on a scale
STANDARD_DEVIATION 2.3 • n=10 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 2.0 • n=11 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 2.2 • n=21 Participants
|
|
Pain Visual Analog Scale (VAS)
|
6 units on a scale
n=10 Participants
|
5 units on a scale
n=11 Participants
|
6 units on a scale
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and One MonthThe visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=10 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).
|
-2 units on a scale
Interval -4.0 to 0.0
|
-1 units on a scale
Interval -2.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline and One MonthPain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 1 month and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=10 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.
|
-0.03 units on a scale
Interval -1.75 to 3.25
|
-0.88 units on a scale
Interval -1.25 to 2.0
|
PRIMARY outcome
Timeframe: Baseline and One MonthThe Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores from questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 1 month and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=10 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
|
-0.14 units on a scale
Interval -4.71 to 3.57
|
-0.36 units on a scale
Interval -1.86 to 2.29
|
PRIMARY outcome
Timeframe: Baseline and One MonthThe GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=10 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Moderately improved
|
3 Participants
|
1 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Markedly worse
|
0 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Moderately worse
|
1 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Mildly worse
|
0 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Same
|
2 Participants
|
5 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Slightly improved
|
2 Participants
|
4 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Markedly improved
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Three MonthsPopulation: At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have the pain assessed using the visual analog scale (missing data for this outcome, analysis conducted on 8 patients).
The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 3 months and the visual analog scale at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
|
-1 units on a scale
Interval -4.0 to 0.0
|
-1 units on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and Three MonthsPopulation: At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain severity (missing data for this outcome, analysis conducted on 8 patients).
Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 3 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.
|
0.25 units on a scale
Interval -1.75 to 2.75
|
-0.37 units on a scale
Interval -2.75 to 3.25
|
SECONDARY outcome
Timeframe: Baseline and Three monthsPopulation: At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain interference (missing data for this outcome, analysis conducted on 8 patients).
The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores together for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 3 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
|
-0.21 units on a scale
Interval -2.71 to 2.0
|
-1.0 units on a scale
Interval -3.71 to 3.71
|
SECONDARY outcome
Timeframe: Baseline and Three MonthsPopulation: At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain symptoms using question 2 in the global response assessment (missing data for this outcome, analysis conducted on 8 patients).
The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).
Outcome measures
| Measure |
Onabotulinumtoxin A
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=8 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Slightly improved
|
1 Participants
|
3 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Markedly worse
|
0 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Moderately worse
|
0 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Mildly worse
|
1 Participants
|
1 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Same
|
1 Participants
|
2 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Moderately improved
|
4 Participants
|
1 Participants
|
|
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Markedly improved
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsThe pain visual analog scale (VAS) is a tool used by the patient to describe their pain intensity. Utilizing the VAS, the patient describes their pain at baseline, before receiving trigger point injections. The VAS ranges from 0 (no pain) to 10 (worst possible pain). Thus, a lower value represents a better outcome.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=7 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
|
-1 units on a scale
Interval -6.0 to 2.0
|
-1 units on a scale
Interval -5.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsPain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 6 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=7 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.
|
0.0 units on a scale
Interval -1.75 to 4.0
|
-1.25 units on a scale
Interval -1.75 to 2.75
|
SECONDARY outcome
Timeframe: Baseline and Six monthsThe Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding together scores for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 6 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased.
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=7 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
|
-0.71 units on a scale
Interval -1.71 to 4.0
|
-1.14 units on a scale
Interval -5.0 to 2.43
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsThe GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).
Outcome measures
| Measure |
Onabotulinumtoxin A
n=9 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=7 Participants
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Markedly worse
|
0 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Moderately worse
|
1 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Mildly worse
|
0 Participants
|
0 Participants
|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Same
|
2 Participants
|
2 Participants
|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Slightly improved
|
2 Participants
|
2 Participants
|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Moderately improved
|
2 Participants
|
3 Participants
|
|
Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Markedly improved
|
2 Participants
|
0 Participants
|
Adverse Events
Onabotulinumtoxin A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Kenalog
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Onabotulinumtoxin A
n=10 participants at risk
Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).
Onabotulinumtoxin A: Intravaginal pelvic floor injection one series
|
Kenalog
n=11 participants at risk
Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.
A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).
Kenalog: Intravaginal pelvic floor injection one series
|
|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
20.0%
2/10 • Number of events 3 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Renal and urinary disorders
Vaginal Yeast Infection
|
20.0%
2/10 • Number of events 3 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Renal and urinary disorders
Increased Pelvic Pain
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Renal and urinary disorders
Urinary Retention
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Numbness/Weakness
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Musculoskeletal and connective tissue disorders
Rib Fracture
|
0.00%
0/10 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Nervous system disorders
Exacerbation of Radiculopathy
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Renal and urinary disorders
Acute Kidney Insufficiency
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Gastrointestinal disorders
Rectal Spasm
|
0.00%
0/10 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Skin and subcutaneous tissue disorders
Facial Abrasions
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Infections and infestations
Thrush
|
0.00%
0/10 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
|
Infections and infestations
Pericoronitis
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
0.00%
0/11 • Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
|
Additional Information
Deborah Hasenau RN, Director, Urology Research
Beaumont Hospital, Royal Oak
Phone: 248-551-0804
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place