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
Qualifiers
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
Treatments tested in this trial
- Urodynamic testing with and without pudendal nerve stimulation
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov