Trial Outcomes & Findings for Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction (NCT NCT01220726)
NCT ID: NCT01220726
Last Updated: 2019-02-26
Results Overview
This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
From Baseline to Day 270
Results posted on
2019-02-26
Participant Flow
The total number of participants recruited and enrolled was 30. A total of 28 completed the study.
Participant milestones
| Measure |
Botox
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
Placebo
200U Saline
Placebo: Placebo injection
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80 years
n=15 Participants
|
68 years
n=13 Participants
|
74 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=15 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=15 Participants
|
13 Participants
n=13 Participants
|
28 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
13 participants
n=13 Participants
|
28 participants
n=28 Participants
|
|
BMI
|
25.7 kg/m^2
n=15 Participants
|
32.5 kg/m^2
n=13 Participants
|
28 kg/m^2
n=28 Participants
|
|
Baseline International Prostate Symptom Score
|
16 units on a scale
n=15 Participants
|
20 units on a scale
n=13 Participants
|
18 units on a scale
n=28 Participants
|
|
Baseline maximum flow rate (Qmax)
|
21.1 mL/s
STANDARD_DEVIATION 10.5 • n=15 Participants
|
16.0 mL/s
STANDARD_DEVIATION 5.8 • n=13 Participants
|
18.6 mL/s
STANDARD_DEVIATION 8.15 • n=28 Participants
|
|
Baseline Voided Volume
|
265.4 mL
STANDARD_DEVIATION 132.3 • n=15 Participants
|
212.6 mL
STANDARD_DEVIATION 74.5 • n=13 Participants
|
239 mL
STANDARD_DEVIATION 103.4 • n=28 Participants
|
|
Baseline postvoid residual volume (PVR)
|
38.3 mL
STANDARD_DEVIATION 39.5 • n=15 Participants
|
34.8 mL
STANDARD_DEVIATION 31.2 • n=13 Participants
|
36.55 mL
STANDARD_DEVIATION 35.35 • n=28 Participants
|
|
Baseline Voiding frequency
|
11 times voided
n=15 Participants
|
10.5 times voided
n=13 Participants
|
10.75 times voided
n=28 Participants
|
|
Type of Procedure: TURP or Laser
TURP
|
6 participants
n=15 Participants
|
6 participants
n=13 Participants
|
12 participants
n=28 Participants
|
|
Type of Procedure: TURP or Laser
Laser
|
7 participants
n=15 Participants
|
9 participants
n=13 Participants
|
16 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Day 270This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
Urinary Frequency
Day 90
|
13 urinations
Interval 7.0 to 13.0
|
8 urinations
Interval 7.0 to 12.0
|
|
Urinary Frequency
Day 180
|
10 urinations
Interval 8.0 to 14.0
|
9 urinations
Interval 8.0 to 12.0
|
|
Urinary Frequency
Day 270
|
8.5 urinations
Interval 5.0 to 10.0
|
9.5 urinations
Interval 7.0 to 10.0
|
|
Urinary Frequency
Baseline
|
10.5 urinations
Interval 8.0 to 13.0
|
11 urinations
Interval 9.0 to 14.0
|
|
Urinary Frequency
Day 7
|
12 urinations
Interval 9.0 to 14.0
|
8.5 urinations
Interval 7.0 to 12.5
|
|
Urinary Frequency
Day 30
|
12 urinations
Interval 8.0 to 13.0
|
8 urinations
Interval 7.0 to 10.0
|
PRIMARY outcome
Timeframe: From Baseline to Day 270This measured the degree of urinary urgency using a 3-day voiding diary. Patients were assessed for the number of urgency episodes they had by answering yes or no.
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
Urgency
Baseline
|
4.5 episodes
Interval 1.0 to 10.0
|
2 episodes
Interval 2.0 to 4.0
|
|
Urgency
Day 7
|
0.5 episodes
Interval 0.0 to 3.0
|
1 episodes
Interval 0.0 to 6.0
|
|
Urgency
Day 30
|
0 episodes
Interval 0.0 to 2.0
|
0 episodes
Interval 0.0 to 1.0
|
|
Urgency
Day 90
|
0 episodes
Interval 0.0 to 1.0
|
0 episodes
Interval 0.0 to 1.0
|
|
Urgency
Day 180
|
1 episodes
Interval 0.0 to 3.0
|
1.5 episodes
Interval 0.0 to 4.0
|
|
Urgency
Day 270
|
0 episodes
Interval 0.0 to 1.0
|
0 episodes
Interval 0.0 to 7.0
|
PRIMARY outcome
Timeframe: From Baseline to Day 270Quality of Life (QoL) is from the ICIQ-QAB (international Consultation of Incontinence Overactive Bladder) Questionnaire. It is scored 25-160 and those with higher scores have higher impact on quality of life.
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
Quality of Life (QoL)
Day 90
|
91 scores on a scale
Interval 66.0 to 103.0
|
88 scores on a scale
Interval 61.0 to 91.0
|
|
Quality of Life (QoL)
Baseline
|
90 scores on a scale
Interval 79.0 to 93.0
|
73 scores on a scale
Interval 60.0 to 92.0
|
|
Quality of Life (QoL)
Day 7
|
97.5 scores on a scale
Interval 82.5 to 100.5
|
81.5 scores on a scale
Interval 47.0 to 92.0
|
|
Quality of Life (QoL)
Day 30
|
92 scores on a scale
Interval 90.0 to 94.0
|
82.5 scores on a scale
Interval 63.0 to 94.0
|
|
Quality of Life (QoL)
Day 180
|
97.5 scores on a scale
Interval 88.5 to 105.5
|
79 scores on a scale
Interval 59.0 to 86.0
|
|
Quality of Life (QoL)
Day 270
|
99 scores on a scale
Interval 93.0 to 107.0
|
79 scores on a scale
Interval 67.0 to 87.0
|
PRIMARY outcome
Timeframe: From Baseline to Day 270ICIQ is a brief validated instrument that is comprehensive for the assessment of incontinence and measures frequency, severity and impact on quality of life. There are a total of 23 items. The overall score ranges from 1-84 with greater values indicating increased symptom severity. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient.
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
International Consultation on Incontinence Questionnaire (ICIQ)
Baseline
|
7 units on a scale
Interval 5.0 to 12.0
|
9 units on a scale
Interval 4.0 to 15.0
|
|
International Consultation on Incontinence Questionnaire (ICIQ)
Day 7
|
5 units on a scale
Interval 3.0 to 7.0
|
8 units on a scale
Interval 5.0 to 11.0
|
|
International Consultation on Incontinence Questionnaire (ICIQ)
Day 30
|
4.5 units on a scale
Interval 1.0 to 8.0
|
7 units on a scale
Interval 5.0 to 10.0
|
|
International Consultation on Incontinence Questionnaire (ICIQ)
Day 90
|
NA units on a scale
Insufficient number of participants with this event.
|
NA units on a scale
Insufficient number of participants with this event.
|
|
International Consultation on Incontinence Questionnaire (ICIQ)
Day 180
|
4 units on a scale
Interval 1.0 to 6.0
|
4 units on a scale
Interval 4.0 to 7.0
|
|
International Consultation on Incontinence Questionnaire (ICIQ)
Day 270
|
4 units on a scale
Interval 3.0 to 4.0
|
8.5 units on a scale
Interval 6.0 to 13.0
|
PRIMARY outcome
Timeframe: From Baseline to Day 270Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
Postvoid Residual Volume (PVR)
Day 90
|
NA mL
Standard Deviation NA
Insufficient number of participants with this event.
|
NA mL
Standard Deviation NA
Insufficient number of participants with this event.
|
|
Postvoid Residual Volume (PVR)
Day 180
|
151.6 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
168.6 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Postvoid Residual Volume (PVR)
Day 270
|
21.2 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
54.4 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Postvoid Residual Volume (PVR)
Baseline
|
34.8 mL
Standard Deviation 31.2
|
36 mL
Standard Deviation 39.5
|
|
Postvoid Residual Volume (PVR)
Day 7
|
41.7 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
137.1 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Postvoid Residual Volume (PVR)
Day 30
|
26.3 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
73.1 mL
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
PRIMARY outcome
Timeframe: From Baseline to Day 270Qmax is the the maximum recorded flow rate
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
Maximum Flow Rate (Qmax)
Day 90
|
13.9 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
10.3 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Maximum Flow Rate (Qmax)
Day 180
|
8.7 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
12.8 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Maximum Flow Rate (Qmax)
Baseline
|
16.0 mL/s
Standard Deviation 5.8
|
21.1 mL/s
Standard Deviation 10.5
|
|
Maximum Flow Rate (Qmax)
Day 7
|
14 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
15.7 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Maximum Flow Rate (Qmax)
Day 30
|
12.7 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
16.5 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
|
Maximum Flow Rate (Qmax)
Day 270
|
9.3 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
12.9 mL/s
Standard Deviation NA
After extensive research and review of files, standard deviation cannot be located.
|
PRIMARY outcome
Timeframe: From Baseline to Day 270International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic)
Outcome measures
| Measure |
Placebo
n=13 Participants
200U Saline
Placebo: Placebo injection
|
Botox
n=15 Participants
200U onabotulinumtoxinA (botox)
Botox: Botox injection
|
|---|---|---|
|
International Prostate Symptom Score (IPSS)
Baseline
|
20 units on a scale
Interval 12.0 to 23.0
|
16 units on a scale
Interval 13.0 to 23.0
|
|
International Prostate Symptom Score (IPSS)
Day 7
|
13.5 units on a scale
Interval 8.0 to 20.0
|
15.5 units on a scale
Interval 13.0 to 25.0
|
|
International Prostate Symptom Score (IPSS)
Day 30
|
13 units on a scale
Interval 11.0 to 18.0
|
15 units on a scale
Interval 8.0 to 18.0
|
|
International Prostate Symptom Score (IPSS)
Day 90
|
16 units on a scale
Interval 10.0 to 24.0
|
10 units on a scale
Interval 5.0 to 17.0
|
|
International Prostate Symptom Score (IPSS)
Day 180
|
14.5 units on a scale
Interval 11.0 to 19.5
|
17 units on a scale
Interval 13.0 to 22.0
|
|
International Prostate Symptom Score (IPSS)
Day 270
|
17 units on a scale
Interval 10.0 to 18.0
|
15 units on a scale
Interval 12.0 to 15.0
|
Adverse Events
Botox
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botox
n=15 participants at risk
Number of adverse events that occurred in the botox arm
|
Placebo
n=13 participants at risk
Number of adverse events that occurred in the placebo arm
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Adverse Events were collected over 1 year
|
0.00%
0/13 • Adverse Events were collected over 1 year
|
|
Renal and urinary disorders
Acute Urinary retention
|
13.3%
2/15 • Adverse Events were collected over 1 year
|
0.00%
0/13 • Adverse Events were collected over 1 year
|
|
Renal and urinary disorders
Urinary tract infection
|
6.7%
1/15 • Adverse Events were collected over 1 year
|
0.00%
0/13 • Adverse Events were collected over 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place