Urinary Bladder, Overactive
Conditions
Keywords
Overactive Bladder, OAB, Women, Neuromodulation, Bioelectronic Medicine
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 that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
Interventions
DEVICEFemPulse System
Device therapy with the FemPulse System
Sponsors
FemPulse Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females 21 years or older with a diagnosis of Overactive Bladder * If of reproductive age, must use a reliable form of contraception
Exclusion criteria
* Pregnant, was recently pregnant or is trying to conceive * Has a metal pelvic implant or any electrically active implanted medical device * Had a previous hysterectomy, pelvic radiation or pelvic cancer * Has significant pelvic organ prolapse * Had bladder treatment with onabotulinumtoxinA in the previous 12 months * Has a significant heart condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OAB Symptom Score | Approximately 11 days in total | OAB symptoms quality of life questionnaire |
| Urogenital Distress Inventory - Short Form | Approximately 11 days in total | OAB-related distress quality of life questionnaire |
| Incontinence Impact Questionnaire - Short Form | Approximately 11 days in total | Impact of OAB quality of life questionnaire |
| All device- and procedure-related adverse events will be collected and tabulated | Approximately 11 days in total | Adverse events |
| Urinary frequency | Approximately 11 days in total | Frequency of and intervals between urinary voids (voids per day and time between voids) |
| Urinary urgency | Approximately 11 days in total | Presence or absence of urgency with each void |
| Urge urinary incontinence (UUI) | Approximately 11 days in total | Presence or absence of UUI with each void |
| OAB-q - Short Form | Approximately 11 days in total | OAB bother quality of life questionnaire |
Countries
United States
Outcome results
None listed