Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorFemPulse Corporation

About this trial

A study to evaluate the safety and effectiveness of FemPulse System

Eligibility criteria

Qualifiers

Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms

Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).

Disqualifiers

Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator.

Not an appropriate study candidate as determined by investigator.

Trial design

Treatments tested in this trial

  • Device Group
  • Medication Group

Treatment groups

151 Participants
are divided into 2 treatment groups

Sponsors and collaborators

FemPulse Corporation

Lead sponsor

Moxie Clinical

Collaborator