Trial Outcomes & Findings for Two Devices for Reflex Voiding Following Spinal Cord Injury (NCT NCT00662207)
NCT ID: NCT00662207
Last Updated: 2014-11-05
Results Overview
Measured via pressure catheter in bladder with a pressure transducer
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
3 hour recording session
Results posted on
2014-11-05
Participant Flow
Only spinal cord injured (SCI) patients using intermittent catheterization or reflex voiding with upper motor neuron injuries participated in this study. Three SCI male patients were enrolled and no adverse events occurred.
Participant milestones
| Measure |
Experimental Group
Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two Devices for Reflex Voiding Following Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
All Participants
n=3 Participants
|
|---|---|
|
Age, Customized
Between 50 and 60 years old
|
3 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Number of Participants with Upper-Motor-Neuron Injuries for SCI
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 hour recording sessionMeasured via pressure catheter in bladder with a pressure transducer
Outcome measures
| Measure |
Experimental Group
n=3 Participants
Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded
|
|---|---|
|
Number of Participants With a Change in Bladder Pressure
|
0 participants
|
PRIMARY outcome
Timeframe: 3 hour recording sessionMeasured via balloon catheter
Outcome measures
| Measure |
Experimental Group
n=3 Participants
Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded
|
|---|---|
|
Number of Participants With a Change in External Urethral Pressure
|
0 participants
|
PRIMARY outcome
Timeframe: 3 hour recording sessionMeasured via balloon catheter
Outcome measures
| Measure |
Experimental Group
n=3 Participants
Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded
|
|---|---|
|
Number of Participants With a Change in Anal Sphincter Pressure
|
0 participants
|
PRIMARY outcome
Timeframe: 3 hour recording sessionOutcome measures
| Measure |
Experimental Group
n=3 Participants
Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded
|
|---|---|
|
Number of Participants With a Urethral Sphincter Contractions
|
0 participants
|
Adverse Events
Experimental Group
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
James S. Walter, Ph.D.
Hines VA Hospital, Research Service
Phone: 708-202-5805
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place