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Urodynamic testing with and without pudendal nerve stimulation for Urinary Incontinence (PNS_UDT Trial)

N/A
Waitlist Available
Led By Kenneth Peters, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after visit 2 activities are complete. an average of 30 days after enrollment.
Awards & highlights

PNS_UDT Trial Summary

This trial will test if acute pudendal nerve stimulation (PNS) can help relieve stress urinary incontinence (SUI) by measuring changes in stress-induced urethral Leak Point Pressures (LPP) before and after the treatment.

Eligible Conditions
  • Urinary Incontinence

PNS_UDT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after visit 2 activities are complete. an average of 30 days after enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and after visit 2 activities are complete. an average of 30 days after enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Leak Point Pressure (LPP) Upon Acute PNS
Identification of All Study-related Adverse Events
Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
+2 more
Secondary outcome measures
Effect of Acute PNS on Max Cystometic Capacity.
Effect of Acute PNS on Post Void Residual.
Effect of Acute PNS on the Urethral Pressure Profile (UPP).

PNS_UDT Trial Design

1Treatment groups
Experimental Treatment
Group I: Urodynamic testing with and without pudendal nerve stimulationExperimental Treatment1 Intervention
The neuromodulation settings of the implanted device will be adjusted to deliver acute simulation. Urodynamic testing (UDT) will be completed by filling the bladder and observing for urinary leakage. The assessment will be completed with the stimulation sets turned off and then turned on. At the end of the UDT the settings will be returned to the previously set therapeutic values. The neuromodulation settings constitute the "dose" and can include the voltage/current amplitude, frequency, pulse width, on time/off time duration and electrode polarity assignments. These parameters are limited by the available ranges of the approved neurostimulation device and will be adjusted during the study by the principal investigator to stay within the safe and comfortable levels for each individual study subject.

Find a Location

Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,854 Total Patients Enrolled
10 Trials studying Urinary Incontinence
1,087 Patients Enrolled for Urinary Incontinence
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital - Royal Oak
26 Previous Clinical Trials
2,022 Total Patients Enrolled
9 Trials studying Urinary Incontinence
1,187 Patients Enrolled for Urinary Incontinence

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study
Kenneth M Peters, MD 2022. "Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128682.
~1 spots leftby Apr 2025
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