Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCorewell Health East
About this trial
The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female aged 18 years old or older
Capable of understanding the clinical study procedures and giving informed consent
Willing and able to undergo the study procedure
Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months
Disqualifiers
Predominant urge incontinence per patient report or medical record
Active symptomatic uncontrolled bladder instability as determined by the investigator
Regularly or intermittently used a urethral catheter
Active bladder cancer (currently undergoing or scheduled to undergo treatment for bladder cancer).
Trial design
Design model
Single group
Treatments tested in this trial
Urodynamic testing with and without pudendal nerve stimulation
Diagnostic testA 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Urodynamic testing and LLP with and without pudendal nerve stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The effect of acute peri-urethral neurostimulation on intra-urethral pressure.
Intra-urethral pressure (measured in cmH2O) will be recorded with stimulation on and off.
Time frame
At stimulation visit, 1 daySecondary outcomes
1
Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.
Safety and tolerability of peri-urethral stimulation will be assessed in related to the incidence of adverse events reported.
Time frame
One week after completing the stimulation visit2
Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation
Leak point pressure (measured in cmH20) will be collected during neurostimulation and without neurostimulation.
Time frame
At stimulation visit, 1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov