FemPulse System for Overactive Bladder

Overseen By Peter Fredericks

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: FemPulse Corporation

Disqualifiers: Neurologic, Psychological, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the FemPulse System, a non-implanted device, can help manage symptoms of overactive bladder (OAB). OAB involves a frequent, sudden urge to urinate, sometimes with accidents, and often requires bathroom visits, even at night. The study seeks women with a cervix, aged 21 or older, who have received a diagnosis of these symptoms from a doctor. Participants must be able to follow study instructions and attend required visits. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to new treatment options for OAB.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the FemPulse System is safe for treating overactive bladder?

Research has shown that the FemPulse System is safe for people. Other studies have found the FemPulse device, a non-implantable vaginal ring, to be easy to use. It delivers gentle electrical signals to nerves that help control the bladder. Reports suggest it could be an effective non-surgical option for those with an overactive bladder. These studies have reported no major safety issues, indicating that the treatment is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FemPulse System is unique because it offers a non-implanted, vaginal electrical stimulation device to manage overactive bladder. Unlike medications that typically involve systemic drug delivery and can have various side effects, the FemPulse System targets the condition locally and non-invasively. This novel approach minimizes the risk of side effects and provides a more comfortable treatment experience, which has researchers excited about its potential to improve the quality of life for individuals with this condition.

What evidence suggests that the FemPulse System is effective for overactive bladder?

Research has shown that the FemPulse System, a non-implanted device used in the vagina, may help treat overactive bladder (OAB). Earlier studies found that it significantly reduced the frequency of urination each day. Participants also reported an improved quality of life and less discomfort from their condition. Importantly, no negative effects related to the device were reported, supporting its safety. The FemPulse System operates by delivering gentle electrical signals to nerves that help control the bladder. These findings suggest that the FemPulse System could effectively manage OAB symptoms. ^{2 4 6 7 8}

Who Is on the Research Team?

Roshini Jain

Principal Investigator

FemPulse Corporation

Are You a Good Fit for This Trial?

This trial is for females over 21 with a cervix who have been diagnosed with Overactive Bladder (OAB) by a physician. Participants must be able to understand and consent to the study's procedures. Those with metal pelvic implants, active medical devices like pacemakers, or significant health conditions that could affect participation are excluded.

Inclusion Criteria

Able to read, comprehend, and reliably provide informed consent and study-related information

Willing and able to comply with study required procedures and visits

I am a woman over 21 with doctor-confirmed OAB symptoms.

Exclusion Criteria

Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator

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

Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the FemPulse System, a non-implanted vaginal electrical stimulation device

2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FemPulse System

Trial Overview The FemPulse System is being tested in this study. The goal is to show that it can be used as intended for women experiencing symptoms of OAB such as urinary urgency, frequency, nocturia, and possibly incontinence.

How Is the Trial Designed?

Group I: Subjects receiving the FemPulse System Experimental Treatment 1 Intervention

Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.

Who Is Running the Clinical Trial?

FemPulse Corporation

Lead Sponsor

Trials

5

Recruited

80+

Published Research Related to This Trial

In a 12-week study involving 516 adults with overactive bladder (OAB) who were dissatisfied with tolterodine, flexible-dose fesoterodine significantly improved symptoms such as micturitions and urgency episodes, with over 80% of participants reporting satisfaction with the treatment.

Fesoterodine was well tolerated, with the most common side effects being dry mouth (23%) and constipation (5%), and no significant safety issues were identified, indicating it is a safe alternative for those who did not respond well to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Wyndaele, JJ., Goldfischer, ER., Morrow, JD., et al.[2021]

Fesoterodine is an effective treatment for overactive bladder syndrome, showing superior results compared to placebo in clinical studies, particularly at the higher dose of 8 mg per day.

As a prodrug, fesoterodine is converted into its active form, 5-hydroxymethyltolterodine, which acts as a muscarinic receptor antagonist, helping to alleviate symptoms of overactive bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome. Michel, MC.[2019]

Overactive bladder (OAB) is recognized as a symptom syndrome indicating lower urinary tract dysfunction, characterized by urgency, frequency, and nocturia, but its definition has evolved since 2001, leading to inconsistencies in prevalence studies.

Raising awareness among healthcare providers about OAB is crucial for improving diagnosis and management, which can enhance patients' quality of life and reduce associated health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and epidemiology of overactive bladder. Wein, AJ., Rovner, ES.[2022]

Overactive bladder (OAB) syndrome affects about 16.5% of the population, significantly impacting daily activities and quality of life, especially in the elderly who often report nocturia as the most bothersome symptom.

Many patients with OAB do not seek medical help, and healthcare providers, including family physicians and gynecologists, may not be familiar with the condition, highlighting the need for increased awareness and proactive assessment in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overactive Bladder Syndrome: Evaluation and Management. Leron, E., Weintraub, AY., Mastrolia, SA., et al.[2021]

Oxybutynin, functional electrical stimulation, and pelvic floor training are effective and well-tolerated treatments for overactive bladder syndrome, but most patients do not achieve complete symptom relief with any single therapy.

There is limited evidence supporting the superiority of combination therapy over individual treatments, highlighting the need for future randomized clinical trials to explore the potential benefits of combining drug and conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between oxybutynin, functional electrical stimulation and pelvic floor training for treatment of detrusor overactivity in women: a review. Arruda, RM., Castro, R., Sartori, M., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07195656

Evaluation of a Non-Implanted Electrical Stimulation ... Study Details | NCT07195656 | Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) | ClinicalTrials.gov.

2. fempulse.com fempulse.com/news_home/fempulse-receives-fda-ide-approval-for-pivotal-clinical-trial/

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.

3. urologytimes.com urologytimes.com/view/fda-greenlights-pivotal-trial-of-wearable-bioelectronic-device-for-oab

FDA 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03874637

Study Details | NCT03874637 | FemPulse Therapy First-in ... The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function.

5. fempulse.com fempulse.com/for-physicians/fempulse-clinical-evidence/

FemPulse Clinical Evidence The improvements in voids per day as well as on questionnaires related to bother and quality of life using the FemPulse device were encouraging compared to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06885099

NCT06885099 | Ease of Use Study of the FemPulse System Overactive Bladder (OAB) ... Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient ...

7. fempulse.com fempulse.com/home/

Home - FemPulse The first application of the FemPulse technology platform is to treat Overactive Bladder (OAB), the bothersome sensation of urgently needing to urinate, often ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03784170

FemPulse Therapy for Overactive Bladder in Women The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that ...