Trial Outcomes & Findings for Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure (NCT NCT05900570)
NCT ID: NCT05900570
Last Updated: 2026-07-22
Results Overview
Measurement of the change in intra-urethral pressure with peri-urethral neurostimulation compared to intra-urethral pressure with no stimulation.
TERMINATED
NA
3 participants
At stimulation visit, 1 day
2026-07-22
Participant Flow
Participants meeting all eligibility criteria were enrolled after the first visit.
All enrolled participants received the same testing.
Participant milestones
| Measure |
Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation
Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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3
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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
Age at screening collected of women diagnosed with stress urinary incontinence enrolled in the study
Baseline characteristics by cohort
| Measure |
Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation
n=3 Participants
Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=9 Participants • Age at screening collected of women diagnosed with stress urinary incontinence enrolled in the study
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=9 Participants • Age at screening collected of women diagnosed with stress urinary incontinence enrolled in the study
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Age, Categorical
>=65 years
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0 Participants
n=9 Participants • Age at screening collected of women diagnosed with stress urinary incontinence enrolled in the study
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Sex: Female, Male
Female
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3 Participants
n=9 Participants • No data analyzed as Zero men were included
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Sex: Female, Male
Male
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0 Participants
n=9 Participants • No data analyzed as Zero men were included
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
Asian
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
Black or African American
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
White
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3 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants • Demographic information gathered at screening and enrollment visit, number of each type of group listed.
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Region of Enrollment
United States
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3 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: At stimulation visit, 1 dayPopulation: No data was collected. No pressure response was observed in any of the patients; thus pressure measurement data was not obtained and recorded for analysis. No data will be collected in the future. This was not an effective method to collect this information.
Measurement of the change in intra-urethral pressure with peri-urethral neurostimulation compared to intra-urethral pressure with no stimulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One week after completing the stimulation visitPopulation: Participants that reported adverse events
Safety and tolerability of peri-urethral stimulation will be assessed in related to the incidence of adverse events reported within one week of stimulation visit.
Outcome measures
| Measure |
Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation
n=3 Participants
Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.
Urodynamic testing with and without pudendal nerve stimulation: A urodynamic test with and without neurostimulation will be conducted. The external neurostimulator device settings will be adjusted to deliver acute nerve stimulation per the individual tolerance level to assess the effect on urethral pressure. A leak point pressure (LLP) during Valsalva maneuver will be assessed with and without acute nerve stimulation.
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Safety and Tolerability Will be Assessed in Relation to the Incidence of Adverse Events Occurring Within One Week of Stimulation Visit.
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0 Participants
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SECONDARY outcome
Timeframe: At stimulation visit, 1 dayPopulation: No data was collected. No pressure response was observed in any of the patients; thus data was not obtained and recorded for analysis. No data will be collected in the future. This was not an effective method to collect this information.
Measurement of the change in valsalva leak point pressure (LLP) with acute peri-urethral neurostimulation compared to without stimulation at stimulation visit.
Outcome measures
Outcome data not reported
Adverse Events
Urodynamic Testing and LLP With and Without Pudendal Nerve Stimulation
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