Trial Outcomes & Findings for OnabotulinumtoxinA Bladder Injection Study (NCT NCT03523091)

Last Updated: 2022-02-10

Results Overview

Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids over a 24 hour period for 3 consecutive days. Number of voids at 3 months are recorded.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

3 months after the initial injection

Results posted on

2022-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	3 Injection Sites OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Overall Study STARTED	1	5
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	3 Injection Sites OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Overall Study Lower dose due to elevated post void residual (PVR)	1	0
Overall Study Withdrawal by Subject	0	3
Overall Study Increase Botox dose	0	1

Baseline Characteristics

OnabotulinumtoxinA Bladder Injection Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=5 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 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	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	4 Participants n=7 Participants	5 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
Region of Enrollment United States	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Baseline number of voids	14 Voids STANDARD_DEVIATION 0 • n=5 Participants	14.9 Voids STANDARD_DEVIATION 6.02 • n=7 Participants	14.8 Voids STANDARD_DEVIATION 5.4 • n=5 Participants
Baseline number of urge incontinence episodes	21 Urge incontinence episodes STANDARD_DEVIATION 0 • n=5 Participants	20.6 Urge incontinence episodes STANDARD_DEVIATION 12.1 • n=7 Participants	20.7 Urge incontinence episodes STANDARD_DEVIATION 10.8 • n=5 Participants
Baseline number of stress incontinence episodes	0 Stress incontinence episodes STANDARD_DEVIATION 0 • n=5 Participants	0.2 Stress incontinence episodes STANDARD_DEVIATION 0.4 • n=7 Participants	0.17 Stress incontinence episodes STANDARD_DEVIATION 0.4 • n=5 Participants
Baseline Symptom Bother	64 score on a scale STANDARD_DEVIATION 0 • n=5 Participants	87.4 score on a scale STANDARD_DEVIATION 14.7 • n=7 Participants	83.5 score on a scale STANDARD_DEVIATION 16.2 • n=5 Participants
Baseline severity of urine leakage	16 score on a scale STANDARD_DEVIATION 0 • n=5 Participants	15 score on a scale STANDARD_DEVIATION 8.5 • n=7 Participants	15.2 score on a scale STANDARD_DEVIATION 7.6 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months after the initial injection

Population: Due to the small number of participants statistical analysis was limited. 3 participants completed 3 month diary data.

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=2 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Number of Incontinence Episodes Per Day	0 Incontinency episodes Standard Deviation 0	15.5 Incontinency episodes Standard Deviation 21.9

SECONDARY outcome

Timeframe: 3 months after the initial injection

Population: Due to the small number of participants data analysis was limited. 3 participants completed data at 3 months.

Per the Overactive Bladder Questionnaire-Short Form (OABq-SF). This validated measure evaluates overactive bladder symptom severity and health related quality of life. For each question, participants will answer how bothered they are by their urinary symptoms from "not at all" (1), "a little bit" (2), "somewhat" (3), "quite a bit" (4), "a great deal" (5), and "a very great deal" (5). Each question will be scored. Scores range from 19-114. The higher the score the greater perceived degree of bladder symptom bother.

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=2 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Degree of Bladder Symptom Bother	23 score on scale Standard Error 0	43 score on scale Standard Error 26.9

SECONDARY outcome

Timeframe: 3 months after the initial injection

Population: Due to small number of participants data analysis was limited. 3 participants had data at 3 months.

Per the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). This validated questionnaire provides a measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. Question items include frequency of urinary incontinence, amount of leakage, overall impact of urinary incontinence, and a self-diagnostic item. Scoring is between 0-21 with greater values indicating increased severity.

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=2 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Severity of Urine Leakage	3 score on a scale Standard Deviation 0	7.5 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: 3 months after the initial injection

Population: Due to a small number of participants data analysis was limited. 3 participants completed GRA data at 3 months.

Per the Global Response Assessment (GRA). Participants will assess overall how their OAB symptoms/condition changed since starting the study. Participants will select, "Markedly worse" (1), "Moderately worse" (2), "Mildly worse" (3), "Same (unchanged)" (4), "Slightly improved" (5), "Moderately improved" (6), or "Markedly improved" (7). Scores are from 1-7 with a greater score indicating a greater improvement of symptoms. Numbers of participants reporting each assessment will be reported.

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=2 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Change in Overactive Bladder Symptoms Markedly Improved	1 Participants	0 Participants
Change in Overactive Bladder Symptoms Moderately Improved	0 Participants	0 Participants
Change in Overactive Bladder Symptoms Slightly Improved	0 Participants	1 Participants
Change in Overactive Bladder Symptoms No change	0 Participants	0 Participants
Change in Overactive Bladder Symptoms Slightly Worse	0 Participants	1 Participants
Change in Overactive Bladder Symptoms Moderately Worse	0 Participants	0 Participants
Change in Overactive Bladder Symptoms Markedly Worse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: After the initial injection

Population: 6 subjects completed baseline VAS scores.

Per the Visual Analog Scale (VAS). Participants will record the amount of pain of performing the treatment on a Visual Analog Scale from 0 (no pain) to 10 (worst pain imaginable). Visual analog scores will be gathered at the end of the injection visit.

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=5 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Overall Patient Pain Tolerability With Treatment	2 score on a scale Standard Deviation 0	3 score on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: 3 months after the initial injection

Population: Due to small number of participants data analysis was limited. 3 subjects had data available for 3 month timepoints.

Per the 3-day voiding diary. Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids, urge and stress incontinence episodes over a 24 hour period for 3 consecutive days.

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=2 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Overall Voiding Symptoms at 3 Months Stress incontinence episodes	0 Episodes Standard Error 0	1.5 Episodes Standard Error 2.1
Overall Voiding Symptoms at 3 Months Average number of voids	12.6 Episodes Standard Error 0	13.2 Episodes Standard Error 2.6
Overall Voiding Symptoms at 3 Months Urge incontinence episodes	0 Episodes Standard Error 0	11 Episodes Standard Error 15.6

SECONDARY outcome

Timeframe: At study completion, 3 months after the initial injection

Population: 3 participants completed the study through the 3 month visit.

Frequency and severity of study-related adverse events

Outcome measures

Outcome measures
Measure	3 Injection Sites n=1 Participants OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=2 Participants OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Safety of Bladder Injections Post-void residual over 300 ml, severity mild	1 Participants	0 Participants
Safety of Bladder Injections Urinary tract infection, severity mild	1 Participants	0 Participants

Adverse Events

3 Injection Sites

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

10 Injection Sites

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	3 Injection Sites n=1 participants at risk OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months	10 Injection Sites n=5 participants at risk OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months
Renal and urinary disorders Post-void resisdual over 300 cc (300 mL)	100.0% 1/1 • Number of events 1 • Adverse event data was collected through study completion, the last study visit was at 3 months.	0.00% 0/5 • Adverse event data was collected through study completion, the last study visit was at 3 months.
Renal and urinary disorders Urinary tract infection	100.0% 1/1 • Number of events 1 • Adverse event data was collected through study completion, the last study visit was at 3 months.	0.00% 0/5 • Adverse event data was collected through study completion, the last study visit was at 3 months.

Additional Information

Jennifer Giordano

William Beaumont Hospital

Phone: 248-551-3517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place