The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure In Women With Stress Urinary Incontinence (SUI) - Urodynamic Early Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Provided authorization to use and disclose information for research purposes

Locations
United States
Michigan
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Contact Information
Primary
Jennifer Giordano, BSN
Jennifer.Giordano@corewellhealth.org
248-551-3517
Backup
Amanda Schonhoff, BSN
Amanda.Schonhoff@corewellhealth.org
248-551-1225
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2027-01
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Sponsors
Leads: Corewell Health East

This content was sourced from clinicaltrials.gov