Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study

Stopped early · Not applicable

Conditions studied: Urinary Incontinence

In brief

The purpose of this study is tp evaluate the changes in stress induced Urethral Leak Point Pressures (LPP) and other urodynamic measurements in response to acute pudendal nerve stimulation (PNS) in patients with a pre-existing implanted urological neurostimulator stimulating the pudendal nerve.

Key facts

Study ID

NCT05128682

Run by

Corewell Health East

People needed

4

Starts

2022-05-24

Expected to finish

2022-09-07

Last updated by the study team

2023-05-16

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women between the ages of 18 and 85 years old, inclusive.
• Implanted with a neurostimulation device for at least 3 months prior to consent (Medtronic Interstim neurostimulator models 3023, 3058, 97810, or similar).
• Implanted with a tined lead that is placed and functionable at the pudendal nerve (Medtronic model 3889 or similar).
• Is capable of understanding clinical study procedures and giving informed consent.
• Willing and able to visit the clinic for the UDT evaluation (study procedure)

You may not qualify if…

• Medically unstable at time of study and unsafe to undergo urodynamic testing as determined by the investigator.
• History of bladder cancer.
• History of pelvic radiotherapy.
• Active gross hematuria.
• Active symptomatic urinary tract infection (UTI)
• Active symptomatic uncontrolled bladder instability as determined by the investigator.
• History or symptoms of cystocele, enterocele, or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator.
• Presence of an artificial urinary sphincter.
• Women who are pregnant and/or have given birth in the previous 12 months
• Any medical condition that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator
• BMI greater than 39.

Where it is running

• Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States
• Beaumont Hospital Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.