FemPulse System for Overactive Bladder

Recruiting at 1 trial location

Overseen By Peter Fredericks

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: FemPulse Corporation

Disqualifiers: Pregnancy, OAB therapy changes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the FemPulse System to determine its effectiveness in helping women manage overactive bladder (OAB) symptoms. OAB causes frequent and urgent urination, impacting daily life. The trial seeks women with a uterus and cervix who have experienced OAB symptoms for over six months. Participants will use the FemPulse System, which includes a ring and a mobile app, to assess any improvement in their condition. As an unphased trial, this study provides participants the chance to contribute to innovative research that could lead to new solutions for managing OAB.

Will I have to stop taking my current medications?

The trial requires participants to maintain consistent medication use, so you should not stop taking your current medications.

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

Research has shown that the FemPulse System is safe for treating overactive bladder. In earlier studies, participants found the device safe and comfortable, with no major safety issues reported. Most people experienced only minor side effects, if any. This suggests that the FemPulse System is generally safe for patients with overactive bladder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FemPulse System for overactive bladder (OAB) because it offers a novel, non-invasive approach to symptom management. Unlike conventional treatments such as medications or invasive procedures, the FemPulse System uses a wearable ring device that delivers gentle neuromodulation directly to the pelvic nerves. This innovative delivery method targets the root cause of OAB symptoms with the potential for fewer side effects and greater convenience. By providing a discreet and user-friendly option, the FemPulse System could significantly improve the quality of life for individuals with OAB.

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

Research has shown that the FemPulse System, which participants in this trial will receive, may help treat overactive bladder (OAB). Earlier studies found that users experienced fewer daily urges to urinate. Surveys indicated that users felt less bothered by their symptoms and enjoyed a better quality of life. Importantly, no negative effects were linked to the device, supporting its safety. These results suggest that the FemPulse System could be a good option for managing OAB symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Roshini Jain

Principal Investigator

Sponsor GmbH

Are You a Good Fit for This Trial?

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.

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 (e.g., maintaining consistent medication use, fluid intake, diary completion)

I am a woman over 21 with overactive bladder symptoms for more than 6 months.

Exclusion Criteria

Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period

Not an appropriate study candidate as determined by investigator

I plan to start or change my overactive bladder treatment during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects receive the FemPulse System for the treatment of their OAB symptoms

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FemPulse System

Trial Overview

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.

How Is the Trial Designed?

Group I: Subjects receiving FemPulse System Experimental Treatment 1 Intervention

Subjects will receive the Ring for the treatment of their OAB symptoms

Who Is Running the Clinical Trial?

FemPulse Corporation

Lead Sponsor

Trials

5

Recruited

80+

Published Research Related to This Trial

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]

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]

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]

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]

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.

fempulse.com

fempulse.com/home/

Home - FemPulse

FemPulse is a private, clinical-stage bioelectronic medicine company developing a novel therapy for the individualized treatment of overactive bladder (OAB) in

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03784170

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.

8.

fempulse.eu

fempulse.eu/en/studies/

Studies - FemPulse™

The study enrolled 21 patients at three sites to evaluate the treatment of adult women diagnosed with overactive bladder as outpatients.