Trial Outcomes & Findings for Overactive Bladder Innovative Therapy Trial (OrBIT) (NCT NCT00448175)
NCT ID: NCT00448175
Last Updated: 2013-05-16
Results Overview
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2013-05-16
Participant Flow
Subjects were recruited by investigator sites with limited advertising
After 12 weekly PTNS treatments, 35 patients were considered responders (reporting of "Moderately" or "Markedly" improved on the Global Response Assessment (GRA))and allowed to continue in the trial through 12 months.
Participant milestones
| Measure |
Urgent PC Treatment Arm
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
|
4mg Daily Tolterodine
90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
|
|---|---|---|
|
12 Weeks PTNS vs. Drug
STARTED
|
50
|
50
|
|
12 Weeks PTNS vs. Drug
COMPLETED
|
41
|
43
|
|
12 Weeks PTNS vs. Drug
NOT COMPLETED
|
9
|
7
|
|
Continued PTNS Through 12 Months
STARTED
|
35
|
0
|
|
Continued PTNS Through 12 Months
COMPLETED
|
25
|
0
|
|
Continued PTNS Through 12 Months
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overactive Bladder Innovative Therapy Trial (OrBIT)
Baseline characteristics by cohort
| Measure |
Urgent PC Treatment Arm
n=50 Participants
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
|
4mg Daily Tolterodine
n=50 Participants
90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
|
Total
n=100 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
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age Continuous
|
57.5 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
57.85 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksTo demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
Outcome measures
| Measure |
Urgent PC Treatment Arm
n=41 Participants
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
|
4mg Daily Tolterodine
n=43 Participants
90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
|
|---|---|---|
|
Frequency of Voids at 12 Weeks
|
-2.4 Voids/day
Standard Deviation 4
|
-2.5 Voids/day
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
Adverse Events
Urgent PC Treatment Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
4mg Daily Tolterodine
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 |
Urgent PC Treatment Arm
n=50 participants at risk
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
|
4mg Daily Tolterodine
n=50 participants at risk
90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
|
|---|---|---|
|
Surgical and medical procedures
Bruising
|
2.0%
1/50 • Number of events 3
|
0.00%
0/50
|
|
Surgical and medical procedures
Leg cramp
|
4.0%
2/50 • Number of events 2
|
0.00%
0/50
|
|
Surgical and medical procedures
Redness/Inflammation at needle site
|
2.0%
1/50 • Number of events 2
|
0.00%
0/50
|
|
Surgical and medical procedures
Pressure/discomfort at needle site
|
6.0%
3/50 • Number of events 3
|
0.00%
0/50
|
|
Surgical and medical procedures
Vasovagal response to needle placement
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Surgical and medical procedures
Jolt felt in leg during treatment
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Surgical and medical procedures
Blurred Vision
|
0.00%
0/50
|
2.0%
1/50 • Number of events 2
|
|
Surgical and medical procedures
Headache
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Surgical and medical procedures
Constipation
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Surgical and medical procedures
Increase urgency/frequency
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Surgical and medical procedures
Severe Dizziness
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place