NCT04001426

Brief Summary

The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

June 24, 2019

Last Update Submit

November 2, 2021

Conditions

Urinary Bladder, Overactive

Keywords

Overactive BladderWomenNeuromodulationBioelectronic Medicine

Outcome Measures

Primary Outcomes (2)

  • Autonomic nervous system response

    The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation

    Up to 6 hours

  • Evoked Potential response

    Surface electrodes will be used to detect whether evoked potentials are generated during device activation

    Up to 6 hours

Study Arms (1)

Monitoring during activation of the FemPulse System

EXPERIMENTAL

Subjects will undergo non-invasive monitoring during activation of the FemPulse System.

Device: The FemPulse System

Interventions

The FemPulse SystemDEVICE

Non-invasive monitoring during activation of the FemPulse System

Monitoring during activation of the FemPulse System

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal healthy women ≥ 21 years old
  • Using contraception if of reproductive age

You may not qualify if:

  • Pregnant, recently pregnant or actively trying to conceive
  • Prior hysterectomy
  • Current or recent urinary tract or vaginal infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Subjects will wear a device and will be monitored non-invasively during activation of the device.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 28, 2019

Study Start

April 4, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations

US(1)