Trial Outcomes & Findings for High Frequency SARS for Neurogenic Bladder and Bowel Emptying (NCT NCT05214378)
NCT ID: NCT05214378
Last Updated: 2025-08-22
Results Overview
urethral sphincter pressure measured in response to presence of stimulation (treatment) compared to pressure in absence of stimulation
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
4 participants
Primary outcome timeframe
1 day
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Treatment Arm
The investigators will test an alternative pattern of sacral root stimulation in individuals who are already implanted with the device. Study participants will act as their own controls.
Finetech-Brindley Sacral Anterior Roots Stimulation System: Electrodes implanted on sacral roots connected to implanted induction coil. External controller box administers stimulation via induction through skin to electrodes. Stimulation activates nerves to modulate bladder, bowel, and sexual functions.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=4 Participants
The investigators will test an alternative pattern of sacral root stimulation in individuals who are already implanted with the device. Study participants will act as their own controls.
Finetech-Brindley Sacral Anterior Roots Stimulation System: Electrodes implanted on sacral roots connected to implanted induction coil. External controller box administers stimulation via induction through skin to electrodes. Stimulation activates nerves to modulate bladder, bowel, and sexual functions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
38 Years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayurethral sphincter pressure measured in response to presence of stimulation (treatment) compared to pressure in absence of stimulation
Outcome measures
| Measure |
Treatment Arm
n=4 Participants
The investigators will test an alternative pattern of sacral root stimulation in individuals who are already implanted with the device. Study participants will act as their own controls.
Finetech-Brindley Sacral Anterior Roots Stimulation System: Electrodes implanted on sacral roots connected to implanted induction coil. External controller box administers stimulation via induction through skin to electrodes. Stimulation activates nerves to modulate bladder, bowel, and sexual functions.
|
|---|---|
|
Urethral Sphincter Pressure
|
50 cmH2O
Standard Deviation 45
|
Adverse Events
Treatment Arm
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
Dennis Bourbeau
Cleveland Department of Veterans Affairs
Phone: 216-791-3800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place