FemPulse System for Overactive Bladder
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: FemPulse Corporation
Disqualifiers: Pregnancy, OAB therapy changes, others
No Placebo Group
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.
12345Eligibility 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
I am a woman over 21 with overactive bladder symptoms for more than 6 months.
Participant Groups
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.
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 Clinic Near You
Research locations nearbySelect from list below to view details:
Univ. of WashingtonSeattle, WA
Holy Cross Women's HospitalFort Lauderdale, FL
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Who is running the clinical trial?
FemPulse CorporationLead Sponsor
References
Overactive Bladder Syndrome: Evaluation and Management. [2021]Overactive bladder (OAB) syndrome is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. OAB affects performance of daily activities and has an estimated prevalence of 16.5%. Many sufferers do not seek medical help. Moreover, many family physicians and even gynecologists are not familiar with this issue. Usually patients suffer from OAB in advanced age. Nocturia is reported as the most bothersome symptom in the elderly population. The aim of our review was to discuss all aspects of this challenging disorder and suggest tools for assessment and management strategies. Practitioners can easily overlook urinary complains if they not directly queried. We would like to encourage practitioners to give more attention to this issue.
Comparison between oxybutynin, functional electrical stimulation and pelvic floor training for treatment of detrusor overactivity in women: a review. [2013]Overactive bladder syndrome is a chronic condition characterized by urgency with or without urge incontinence, usually with frequency and nocturia. The usual urodynamic diagnosis is the presence of detrusor overactivity. Overactive bladder is a common condition that has a negative impact on the quality of life of the affected individuals. In this review we provide a summary of relevant recent publications concerning the effectiveness of oxybutynin, functional electrical stimulation and pelvic floor training alone or in combination for the management of this syndrome.
Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. [2021]To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment.
Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome. [2019]Fesoterodine is a newly approved drug for the treatment of overactive bladder syndrome.
Definition and epidemiology of overactive bladder. [2022]The Standardisation Subcommittee of the International Continence Society (ICS) now recognizes overactive bladder (OAB) as a "symptom syndrome suggestive of lower urinary tract dysfunction." It is specifically defined as "urgency, with or without urge incontinence, usually with frequency and nocturia." The ICS definition was not formulated until January 2001 and was not formally approved until September 2001. Therefore, collection and discussion of the epidemiologic characteristics of OAB are somewhat hampered by the different definitions of this condition used by different investigators. Most communications that appeared before 2000 more often described characteristics of incontinence rather than OAB, and the estimates of OAB prevalence within those studies varied significantly. Until recently, little definite epidemiologic information was available on the prevalence and comorbidities of OAB. An important challenge in treating OAB is to increase awareness of this significant problem worldwide and to impress on other specialists and primary care physicians the importance of identifying this clinical problem and managing it in a way that will maximize quality-of-life improvement while minimizing morbidity.