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

Trial Summary

What is the purpose of this trial?

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.

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.

How is the FemPulse System treatment different from other treatments for overactive bladder?

The FemPulse System is unique because it likely involves a novel approach or technology not covered by existing treatments like medications or physical therapies, but specific details about its mechanism or administration are not provided in the available research. ^{1 2 3 4 5}

Research Team

Roshini Jain

Principal Investigator

Sponsor GmbH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Overactive Bladder Syndrome: Evaluation and Management. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Comparison between oxybutynin, functional electrical stimulation and pelvic floor training for treatment of detrusor overactivity in women: a review. [2013]

3. India pubmed.ncbi.nlm.nih.gov

Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Definition and epidemiology of overactive bladder. [2022]