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

NCT05128682 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-05-16

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Kenneth Peters, MD · Beaumont Hospital - Royal Oak

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2022-07-27
Completion
2022-09-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128682 on ClinicalTrials.gov