Trial Outcomes & Findings for Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate (NCT NCT01605617)
NCT ID: NCT01605617
Last Updated: 2014-02-05
Results Overview
TERMINATED
PHASE4
4 participants
From baseline to 12 weeks post treatment
2014-02-05
Participant Flow
Participant milestones
| Measure |
PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo
Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
|
PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate
Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
|
|---|---|---|
|
First Intervention
STARTED
|
2
|
2
|
|
First Intervention
COMPLETED
|
2
|
1
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout Period of 4 Weeks
STARTED
|
2
|
1
|
|
Washout Period of 4 Weeks
COMPLETED
|
0
|
0
|
|
Washout Period of 4 Weeks
NOT COMPLETED
|
2
|
1
|
|
Second Intervention
STARTED
|
0
|
0
|
|
Second Intervention
COMPLETED
|
0
|
0
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo
Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
|
PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate
Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
|
Washout Period of 4 Weeks
Study Terminated
|
2
|
1
|
Baseline Characteristics
Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
Baseline characteristics by cohort
| Measure |
PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo
n=2 Participants
Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.
|
PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate
n=2 Participants
Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate.
|
Total
n=4 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 weeks post treatmentPopulation: The study was terminated due to a low recruitment rate prior to subjects completing treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks post treatmentPopulation: The study was terminated due to a low recruitment rate prior to subjects completing treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 12 weeks post treatmentPopulation: The study was terminated due to a low recruitment rate prior to subjects completing treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 12 weeks post treatmentPopulation: The study was terminated due to a low recruitment rate prior to subjects completing treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 12 weeks post treatmentPopulation: The study was terminated due to a low recruitment rate prior to subjects completing treatment.
The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks post treatmentPopulation: The study was terminated due to a low recruitment rate prior to subjects completing treatment.
The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from "not at all" to "a very great deal." Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort).
Outcome measures
Outcome data not reported
Adverse Events
While on PTNS + Fesoterodine Fumarate First
While on PTNS + Placebo First
While on PTNS + Placebo Second
While on PTNS + Fesoterodine Fumarate Second
Serious adverse events
| Measure |
While on PTNS + Fesoterodine Fumarate First
n=2 participants at risk
Participants were given PTNS + 4mg of fesoterodine fumarate (12 weeks)
|
While on PTNS + Placebo First
n=2 participants at risk
Participants were given PTNS + placebo (12 weeks)
|
While on PTNS + Placebo Second
Participants were to be given PTNS + placebo (12 weeks)
|
While on PTNS + Fesoterodine Fumarate Second
Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks)
|
|---|---|---|---|---|
|
Cardiac disorders
Irregular heartbeat/palpitations
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
—
0/0
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place