Back to resultsFemPulse Therapy First-in-Human Experience
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treament
Sham Control
Sponsored by
About this trial
This is an interventional other trial for Urinary Bladder, Overactive focused on measuring Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine, Non-significant Risk
Eligibility Criteria
Inclusion Criteria:
- Females ≥21 yrs with Overactive Bladder
Exclusion Criteria:
- Is or was recently pregnant
- Has a metal pelvic implant or any electrically active implanted medical device
- Has a urinary tract or vaginal infection
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
- Has a significant heart condition or a history of vasovagal reaction or low blood pressure
Sites / Locations
- Minnesota Urology
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Sham Control
Arm Description
Active therapy
Sham Control
Outcomes
Primary Outcome Measures
Adverse Events
All device- and procedure-related adverse events will be collected and tabulated
Placeability and comfort of the device
Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.
Secondary Outcome Measures
Frequency of urinary voids
The number of voids per day will be tabulated
Intervals between urinary voids
The time between voids (hours:minutes) will be tabulated
Urge urinary incontinence (UUI)
Presence or absence of UUI with each void
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03874637
Brief Title
FemPulse Therapy First-in-Human Experience
Official Title
Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FemPulse Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
Detailed Description
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine, Non-significant Risk
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Active therapy
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
Sham Control
Intervention Type
Device
Intervention Name(s)
Treament
Intervention Description
Placement of the FemPulse System with therapy delivery
Intervention Type
Device
Intervention Name(s)
Sham Control
Intervention Description
Placement of the FemPulse System without therapy delivery
Primary Outcome Measure Information:
Title
Adverse Events
Description
All device- and procedure-related adverse events will be collected and tabulated
Time Frame
3 days in total
Title
Placeability and comfort of the device
Description
Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.
Time Frame
3 days in total
Secondary Outcome Measure Information:
Title
Frequency of urinary voids
Description
The number of voids per day will be tabulated
Time Frame
3 days in total
Title
Intervals between urinary voids
Description
The time between voids (hours:minutes) will be tabulated
Time Frame
3 days in total
Title
Urge urinary incontinence (UUI)
Description
Presence or absence of UUI with each void
Time Frame
3 days in total
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females ≥21 yrs with Overactive Bladder
Exclusion Criteria:
Is or was recently pregnant
Has a metal pelvic implant or any electrically active implanted medical device
Has a urinary tract or vaginal infection
Had a previous hysterectomy, pelvic radiation or pelvic cancer
Has significant pelvic organ prolapse
Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
Has a significant heart condition or a history of vasovagal reaction or low blood pressure
Facility Information:
Facility Name
Minnesota Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FemPulse Therapy First-in-Human Experience
We'll reach out to this number within 24 hrs