Trial Outcomes & Findings for FREEOAB Study for Overactive Bladder (NCT NCT04547920)
NCT ID: NCT04547920
Last Updated: 2025-02-26
Results Overview
The percentage of responders in voiding (urinary frequency) events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total voids per day relative to an upper normal limit of 8 voids per day, or returns to normal (8 or fewer voids per day) at Week 12.
COMPLETED
NA
96 participants
12 Weeks
2025-02-26
Participant Flow
Participant milestones
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Initial 12-Week Study
STARTED
|
96
|
|
Initial 12-Week Study
COMPLETED
|
88
|
|
Initial 12-Week Study
NOT COMPLETED
|
8
|
|
Optional 12-Month Long Term Follow-Up
STARTED
|
50
|
|
Optional 12-Month Long Term Follow-Up
COMPLETED
|
39
|
|
Optional 12-Month Long Term Follow-Up
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FREEOAB Study for Overactive Bladder
Baseline characteristics by cohort
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=96 Participants
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 13 • n=99 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White / Caucasian
|
77 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
|
Height
|
164 centimeters (cm)
STANDARD_DEVIATION 9.11 • n=99 Participants
|
|
Weight
|
83.7 kilograms (kg)
STANDARD_DEVIATION 26.6 • n=99 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Number of Subjects with Reported Voiding Symptom (Avg \> 8 / day) at Baseline
The percentage of responders in voiding (urinary frequency) events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total voids per day relative to an upper normal limit of 8 voids per day, or returns to normal (8 or fewer voids per day) at Week 12.
Outcome measures
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=89 Participants
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Percentage of Responders in Voiding (Urinary Frequency) Events
|
55 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Number of Subjects with Reported Urgency Symptom (Avg Daily Urges \> 0) at Baseline
Percentage of Responders in Incontinence (Leak) Events (IE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total incontinence events per day, or returns to normal (0 events per day), at Week 12.
Outcome measures
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=76 Participants
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Percentage of Responders in Incontinence (Leak) Events (IE)
|
47 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Number of Subjects with Reported Incontinence Symptom (Avg Daily Leaks \> 0) at Baseline
Percentage of Responders in Urgency Events (UE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total urgency events per day, or returns to normal (0 events per day) at Week 12.
Outcome measures
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=74 Participants
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Percentage of Responders in Urgency Events (UE)
|
41 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Number of Subjects with ≥ 50% Change in Any Symptom
Overall Responder Rate at 12 Weeks, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at Week 12.
Outcome measures
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=94 Participants
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Overall Responder Rate at 12 Weeks
|
74 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: \# of Subjects with ≥ 50% Change in Any Symptom
Overall Responder Rate at 12 Months, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at 6 months.
Outcome measures
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=39 Participants
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Overall Responder Rate at 12 Months
|
30 Participants
|
Adverse Events
12 Weeks Followed by Optional 12 Month Continuation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
12 Weeks Followed by Optional 12 Month Continuation
n=96 participants at risk
Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.
|
|---|---|
|
Renal and urinary disorders
Pollakiuria (Frequent Urination)
|
4.2%
4/96 • Length of Study (12 months)
|
|
Musculoskeletal and connective tissue disorders
Foot Pain / Intense Stimulation
|
3.1%
3/96 • Length of Study (12 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm (Foot Cramping)
|
2.1%
2/96 • Length of Study (12 months)
|
|
Skin and subcutaneous tissue disorders
Foot Contusion
|
1.0%
1/96 • Length of Study (12 months)
|
|
Nervous system disorders
Paraesthesia (Tingling Sensation)
|
2.1%
2/96 • Length of Study (12 months)
|
|
Skin and subcutaneous tissue disorders
Thermal Burn
|
1.0%
1/96 • Length of Study (12 months)
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
1.0%
1/96 • Length of Study (12 months)
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.1%
2/96 • Length of Study (12 months)
|
|
Skin and subcutaneous tissue disorders
Varicose Veins
|
1.0%
1/96 • Length of Study (12 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place