Clinical trial NCT05128682: Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study
Official title: The Effect Of Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic: Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence
Keywords: pudendal nerve
urinary incontinence
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects who meet all eligibility criteria will be enrolled in the study and will undergo urodynamic testing with UPP.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Patients with a neurostimulator implanted at the pudendal nerve will be enrolled and undergo urodynamic testing. Before testing, study staff will provide an oral antibiotic (to reduce the risk of infection) and adjust the stimulation settings with a goal to increase urethral pressure from baseline by at lest 20cm H2O, without causing the patient discomfort/distress. These settings will be used throughout urodynamics. Before filling the bladder, a urethral pressure profile study will be completed 3 times with stimulation off, then 3 times with stimulation on. Leak point pressure (LPP) testing will then be completed. The patient's bladder will be filled following standard urodynamic testing protocol. Filling will be paused every 50-100mL to complete LPP assessment. Subjects will be asked to complete a light cough, medium cough, forceful cough, and Valsalva maneuver (in that order). Detrusor pressure will be measured at each event, and staff will document whether or not a leak was elicited. This will be completed with stimulation off, then with stimulation on, as the bladder is filled. Once the subject reports a strong urge to void, urethral pressure profile assessment will be completed again: 3 times with stimulation off, then 3 times with stimulation on. Once urodynamic testing is complete and the patient's bladder is emptied, a measurement of urethral pressure will be completed with stimulation off, then during 5 seconds of stimulation, then again with stimulation off.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
measure: Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation.
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
measure: Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation.
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
measure: Identification of All Study-related Adverse Events
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
measure: Changes in Leak Point Pressure (LPP) Upon Acute PNS
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Secondary outcomes:
measure: Effect of Acute PNS on the Urethral Pressure Profile (UPP).
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
measure: Effect of Acute PNS on Max Cystometic Capacity.
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
measure: Effect of Acute PNS on Post Void Residual.
timeFrame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital Royal Oak
state: Michigan
Study officials:
affiliation: Beaumont Hospital - Royal Oak
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: