Electrical Stimulation Device for Overactive Bladder
(EVANESCE-II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the FemPulse System to determine its safety and effectiveness in helping people with an overactive bladder (OAB). OAB causes a sudden urge to urinate, often leading to frequent bathroom trips and nighttime urination. The trial compares the FemPulse System with standard medication for OAB. Women who have experienced OAB symptoms for more than six months may be suitable candidates for this study. Participants must be willing to follow the study's procedures and attend required visits. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment options for OAB.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it mentions that you should maintain consistent medication use. It's best to discuss your specific medications with the study team.
What prior data suggests that the FemPulse System is safe for overactive bladder?
Studies have shown that the FemPulse System, a device for treating overactive bladder, is safe to use. Research indicates that in controlled clinical trials, the FemPulse device proved both safe and comfortable for participants, suggesting it is well-tolerated by users. No reports of major side effects have emerged, indicating that the treatment is generally safe for people to try.12345
Why are researchers excited about this trial?
Researchers are excited about the FemPulse System for overactive bladder because it uses a novel approach with electrical stimulation, which is different from the typical medications or surgeries. Unlike standard treatments like anticholinergics or beta-3 adrenergic agonists, which work by altering bladder muscle activity chemically, the FemPulse System potentially offers a non-invasive and drug-free alternative that directly targets the nerves controlling bladder function. This could mean fewer side effects and a more direct way to manage symptoms, offering hope for patients who may not respond well to traditional medications.
What evidence suggests that the FemPulse System is effective for overactive bladder?
Studies have shown that the FemPulse System, which participants in this trial may receive, can greatly improve symptoms of overactive bladder (OAB) in women. In earlier trials, many patients reported needing fewer bathroom visits and feeling less urgency. Importantly, these benefits occurred without any device-related side effects, highlighting its safety. The device sends gentle electrical pulses to help manage bladder function. This method targets the nerve signals that cause OAB, offering a promising alternative to traditional medications. Another group in this trial will receive medication, allowing researchers to compare the FemPulse System's effectiveness against traditional treatments.23567
Who Is on the Research Team?
Suzette Sutherland, MD
Principal Investigator
FemPulse Corporation
Are You a Good Fit for This Trial?
This trial is for women over 21 with a uterus and cervix who have been diagnosed with Overactive Bladder (OAB) for more than six months. Participants must be able to follow the study's procedures, like keeping a diary of their symptoms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the FemPulse System or medication for overactive bladder
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FemPulse System
Trial Overview
The study is testing the safety and effectiveness of the FemPulse System, which is a non-implanted electrical stimulation device designed to treat OAB. Participants will be divided into two groups: one using medication and another using the FemPulse device.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects receiving medication
Subjects receiving the FemPulse System
Find a Clinic Near You
Who Is Running the Clinical Trial?
FemPulse Corporation
Lead Sponsor
Moxie Clinical
Collaborator
Citations
FemPulse Therapy for Overactive Bladder in Women
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
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urologytimes.com
urologytimes.com/view/fda-greenlights-pivotal-trial-of-wearable-bioelectronic-device-for-oabFDA greenlights pivotal trial of wearable bioelectronic ...
Previous trials showed significant improvements in OAB symptoms, with no device-related adverse events reported, supporting its safety and ...
FemPulse Receives FDA IDE Approval for Pivotal Clinical ...
The initial application is to treat the one in six women worldwide suffering from overactive bladder (OAB). For more information, visit www.
Study Details | NCT03874637 | FemPulse Therapy First-in- ...
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women. Detailed Description. The FemPulse ...
FemPulse Positive Clinical Data To Be Presented at SUFU ...
The initial application is to treat the one in six women worldwide suffering from overactive bladder (OAB). FemPulse has not received ...
NCT06885099 | Ease of Use Study of the FemPulse System
OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms . Able to read, ...
Home - FemPulse
FemPulse is a private, clinical-stage bioelectronic medicine company developing a novel therapy for the individualized treatment of overactive bladder (OAB) in
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