Ease of Use Study of the FemPulse System

Description

The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Conditions

Overactive Bladder (OAB)

Study Overview

Study Details

Study overview

The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Ease of Use Study of the FemPulse System

Ease of Use Study of the FemPulse System

Condition
Overactive Bladder (OAB)
Intervention / Treatment

-

Contacts and Locations

Fort Lauderdale

Holy Cross Women's Hospital, Fort Lauderdale, Florida, United States, 33334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, 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 .
  • 2. Able to read, comprehend, and reliably provide informed consent and study-related information.
  • 3. Willing and able to comply with study required procedures and visits
  • 1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
  • 2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.
  • 4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

FemPulse Corporation,

Roshini Jain, STUDY_DIRECTOR, FemPulse Corporation

Study Record Dates

2025-08-31