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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05128682
Other study ID # 2021-286
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 24, 2022
Est. completion date September 7, 2022

Study information

Verified date May 2023
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date September 7, 2022
Est. primary completion date July 27, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Urodynamic testing with and without pudendal nerve stimulation
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.

Locations

Country Name City State
United States Beaumont Hospital - Royal Oak Royal Oak Michigan
United States Beaumont Hospital Royal Oak Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation. PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated. After Visit 2 activities are complete. An average of 30 days after enrollment.
Primary Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation. PNS final settings including: pulse frequencies, measured in Hz, when subject first verbalizes sensation. After Visit 2 activities are complete. An average of 30 days after enrollment.
Primary Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation. PNS final settings including: pulse widths, measured in µs, when the subject first verbalizes sensation. After Visit 2 activities are complete. An average of 30 days after enrollment.
Primary Identification of All Study-related Adverse Events Safety and tolerability will be assessed in relation to the incidence of study related adverse events reported. After Visit 2 activities are complete. An average of 30 days after enrollment.
Primary Changes in Leak Point Pressure (LPP) Upon Acute PNS Measurement of the change in LPP with acute PNS compared to without stimulation. To assess LPP, the urethral pressure increase will be calculated by subtracted pressure with and without stimulation at the "final setting". In cm water. After Visit 2 activities are complete. An average of 30 days after enrollment.
Secondary Effect of Acute PNS on the Urethral Pressure Profile (UPP). Measure the maximum urethral closure pressure with and without programmed pudendal nerve stimulation. In cm water.
Urethral pressure profile is a test of the bladder neck, urethra, and urethral sphincters that is completed with urodynamic equipment. A small catheter is pulled at a constant rate from the bladder neck down the urethra to provide the functional length of the urethra and points of maximal urethral resistance at the urethral sphincter. It is a procedure used to measure the competency of the urethral sphincter (outflow resistance).
After Visit 2 activities are complete. An average of 30 days after enrollment.
Secondary Effect of Acute PNS on Max Cystometic Capacity. Max cystometic capacity will be collected, with and without programmed PNS, the difference will be reported. In mL. After Visit 2 activities are complete. An average of 30 days after enrollment.
Secondary Effect of Acute PNS on Post Void Residual. Post void residual collected at end of UDT testing. Measured in mL. After Visit 2 activities are complete. An average of 30 days after enrollment.
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