Urinary Bladder, Overactive
Conditions
Keywords
Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine, Non-significant Risk
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.
Interventions
DEVICETreament
Placement of the FemPulse System with therapy delivery
DEVICESham Control
Placement of the FemPulse System without therapy delivery
Sponsors
FemPulse Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 days in total | All device- and procedure-related adverse events will be collected and tabulated |
| Placeability and comfort of the device | 3 days in total | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of urinary voids | 3 days in total | The number of voids per day will be tabulated |
| Intervals between urinary voids | 3 days in total | The time between voids (hours:minutes) will be tabulated |
| Urge urinary incontinence (UUI) | 3 days in total | Presence or absence of UUI with each void |
Countries
United States
Outcome results
None listed