Trial Outcomes & Findings for Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) (NCT NCT00529386)
NCT ID: NCT00529386
Last Updated: 2019-03-25
Results Overview
At 12 weeks there were no GRA responders. Study stopped because of futility.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-03-25
Participant Flow
Participant milestones
| Measure |
Botox
300 IU botox
Botox: 300 units
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Botox
300 IU botox
Botox: 300 units
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Baseline characteristics by cohort
| Measure |
Botox
n=7 Participants
300 IU botox
Botox: 300 units
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 7 CPCPPS patients enrolled and analysed before stopping study because of futility
At 12 weeks there were no GRA responders. Study stopped because of futility.
Outcome measures
| Measure |
Botox
n=7 Participants
300 IU botox
Botox: 300 units
|
|---|---|
|
GRA
|
0 Participants
|
Adverse Events
Botox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place