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Behavioural Intervention

FemPulse System for Overactive Bladder

N/A
Recruiting
Research Sponsored by FemPulse Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to show that the FemPulse System can be used according to the provided instructions."

Who is the study for?
This trial is for women over 21 years old with a uterus and cervix, who have been diagnosed with Overactive Bladder (OAB) for more than six months. Participants must be able to understand and give informed consent, follow study procedures like keeping a diary, maintain consistent medication use, and operate the FemPulse System along with its mobile app.
What is being tested?
The study aims to show that the FemPulse System can be used as directed in its Instructions for Use. The system is designed to help manage symptoms of OAB. This usability study will require participants to interact with both the device and an accompanying mobile application.
What are the potential side effects?
Since this is a usability study focusing on how participants interact with the FemPulse System rather than drug effects, specific side effects are not detailed here. However, potential discomfort or issues related to using medical devices could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 21 with overactive bladder symptoms for more than 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Satisfaction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects receiving FemPulse SystemExperimental Treatment1 Intervention
Subjects will receive the Ring for the treatment of their OAB symptoms

Find a Location

Who is running the clinical trial?

FemPulse CorporationLead Sponsor
3 Previous Clinical Trials
38 Total Patients Enrolled
Roshini JainStudy DirectorSponsor GmbH
30 Previous Clinical Trials
26,279 Total Patients Enrolled
~4 spots leftby Dec 2024
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