Trial Outcomes & Findings for Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study (NCT NCT05128682)
NCT ID: NCT05128682
Last Updated: 2023-05-16
Results Overview
PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
After Visit 2 activities are complete. An average of 30 days after enrollment.
Results posted on
2023-05-16
Participant Flow
Participant milestones
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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4
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study
Baseline characteristics by cohort
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=4 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Population: One subject did not have a pulse amplitude recorded.
PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated.
Outcome measures
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=3 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
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0.76 mA
Standard Deviation 0.45
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PRIMARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.PNS final settings including: pulse frequencies, measured in Hz, when subject first verbalizes sensation.
Outcome measures
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=4 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
|
|---|---|
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Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation.
|
45 Hz
Standard Deviation 20.18
|
PRIMARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Population: One participant did not have a pulse width recorded
PNS final settings including: pulse widths, measured in µs, when the subject first verbalizes sensation.
Outcome measures
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=3 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation.
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210 µs
Standard Deviation 0
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PRIMARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Safety and tolerability will be assessed in relation to the incidence of study related adverse events reported.
Outcome measures
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=4 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Identification of All Study-related Adverse Events
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0 Participants
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PRIMARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Population: No leaks were noted in any of the four participants.
Measurement of the change in LPP with acute PNS compared to without stimulation. To assess LPP, the urethral pressure increase will be calculated by subtracted pressure with and without stimulation at the "final setting". In cm water.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Population: Two participants did not complete.
Measure the maximum urethral closure pressure with and without programmed pudendal nerve stimulation. In cm water. Urethral pressure profile is a test of the bladder neck, urethra, and urethral sphincters that is completed with urodynamic equipment. A small catheter is pulled at a constant rate from the bladder neck down the urethra to provide the functional length of the urethra and points of maximal urethral resistance at the urethral sphincter. It is a procedure used to measure the competency of the urethral sphincter (outflow resistance).
Outcome measures
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=2 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Effect of Acute PNS on the Urethral Pressure Profile (UPP).
Max Urethral Closure Pressure With Stimulation
|
53.9 cm water
Standard Deviation 4.21
|
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Effect of Acute PNS on the Urethral Pressure Profile (UPP).
Max Urethral Closure Pressure No Stimulation
|
51.2 cm water
Standard Deviation 3.08
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SECONDARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Population: Not collected on any participants due to testing limitations.
Max cystometic capacity will be collected, with and without programmed PNS, the difference will be reported. In mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After Visit 2 activities are complete. An average of 30 days after enrollment.Population: Three participants did not have data collected.
Post void residual collected at end of UDT testing. Measured in mL.
Outcome measures
| Measure |
Urodynamic Testing With and Without Pudendal Nerve Stimulation
n=1 Participants
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. UDT will be completed by filling the bladder and observing for urinary leakage. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
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|---|---|
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Effect of Acute PNS on Post Void Residual.
|
30 mL
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Adverse Events
Urodynamic Testing With and Without Pudendal Nerve Stimulation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place