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Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives: * Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland * Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics * Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples * Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
This research study is being done to compare the effectiveness two drugs: an extended release torsemide (ERT) versus generic immediate release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF). This study will include CHF patients who experience worsening OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits. There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws. Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.
Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life. Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations. Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.
Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder. IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA is the most expensive formulation on the market. Compare the efficacy of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals) to onabotulinumtoxinA (Botox®, Allergan) for treatment of OAB. Study design: A single-blinded, randomized non-inferiority trial of IncobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals) to OnabotulinumtoxinA (Botox®, Allergan) in treatment of OAB. Target Population: The study findings will be applicable to all women 18 years of age or older with OAB symptoms associated with urinary urgency incontinence. Procedure: All patients that presents to urogynecology clinic at Walter Reed National Medical Military Center will be screened for inclusion and exclusion criteria. Patients that meet criteria will be offered to participate in the study. After enrollment patient will complete demographics data sheet, 24 hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. Patients will be randomized by the principal investigator and the allocated treatment will be reveled by the treating provider to the treating provider only. Patient will have a follow up at 2-6 weeks and 6-9 months after procedure. During the follow up appointments patient will be asked to fill out 24-hour voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys.
The goal of this pilot study is to assess the impact of yoga as a treatment modality in pediatric patients age 8-18 diagnosed with idiopathic overactive bladder as measured by validated questionnaires and urinary biomarkers. The main question it aims to answer is: Does yoga help improve overactive bladder symptoms in this patient population? Participants will take part in a weekly yoga session for a total of 6 weeks with validated questionnaires and urinary samples for biomarkers to be completed at the beginning, middle and end of the study. This study will follow a cross-over study design and patients will receive standard of care while not in the active treatment arm.
The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
The objective of this research is to perform a non-masked, non-inferiority randomized controlled trial to assess the quality of life (QOL) of women with idiopathic overactive bladder (OAB) before and after treatment with percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) of tibial nerve. The target population is patients with OAB who previously failed first- and second-line treatments and desire non-surgical management.
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.
The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.