332 Clinical Trials for Various Conditions
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer, Prostatectomy
To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .
Overactive Bladder
The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder The main questions it aims to answer are: •Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\] Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis. Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.
Overactive Bladder Syndrome
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.
Heart Failure, Overactive Bladder, Incontinence
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.
Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urgency-frequency Syndrome, Urinary Incontinence, Urinary Incontinence, Urge
Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. OAB syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. Evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. Diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (QOL).3 However, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). In addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. Vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. Poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. This leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. The study aims to evaluate a tailored patient-centered tool to begin the treatment process.
Overactive Bladder Syndrome, Urinary Incontinence
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.
Overactive Bladder Syndrome
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.
Overactive Bladder Syndrome
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.
Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
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.
Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases
Overactive bladder (OAB) is a highly prevalent disease process that, when refractory to oral medication therapy, can be effectively managed with injection of botulinum toxin A (BTA) into the detrusor muscle of the bladder. However, the traditional procedure requires a cystoscope inserted into the bladder which can be painful and is associated with a risk of urinary tract infection. The purpose of this study is to determine if transvaginal injection of BTA into the detrusor muscle of the bladder wall is feasible to perform, and efficacious for the treatment of refractory overactive bladder.
Overactive Bladder, Bladder, Overactive, Urge Incontinence, Urgency Urinary, Urinary Frequency/Urgency
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life. Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these. A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints. Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart). The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated. The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during HoLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB). The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively. The investigators hypothesize that administering bladder botox injections during HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP surgery for their obstructive and irritative symptoms.
Benign Prostatic Hyperplasia, Overactive Bladder
This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.
Overactive Bladder, Urinary Urge Incontinence, Urge Incontinence
This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia and the second group will have cystoscopy with placebo TENS.
Urinary Incontinence, Overactive Bladder, Pain, Acute
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.
Overactive Bladder, Overactive Bladder Syndrome, Urinary Urge Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge
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.
Overactive Bladder Syndrome
To evaluate the safety and durability of the TheraNova Neuromodulation System in overactive bladder (OAB) patients.
Overactive Bladder
In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).
Overactive Bladder
Overactive bladder (OAB) affects an estimated 16-30% of women in the US and urgency urinary incontinence (UUI) affects 7-11% of women with OAB. It is known that repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) can modulate the pelvic floor muscle activity with potential benefits for various urologic conditions. The goal of this study is to assess feasibility of rTMS as a treatment option for OAB with UUI by determining which rTMS frequency is most effective in targeting sensory components of OAB, namely urinary urgency, and also in targeting the brain network known to be involved in OAB.
Overactive Bladder, Urge Incontinence
The purpose of this study is to assess how psychological stress and anxiety relate to bladder sensitivity and to psychological burdens in people with overactive bladder and how this can be measured effectively. UPDATE: June 2024 - Upon guidance from the NIDDK, this record was updated to an observational study as it was determined not to be an interventional clinical trial.
Overactive Bladder, Stress, Psychological, Anxiety
This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.
Overactive Bladder
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.
Overactive Bladder Syndrome, Overactive Bladder, Urinary Frequency, Urinary Urgency
This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.
Overactive Bladder, Urge Incontinence, Pelvic Floor Disorders
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
Overactive Bladder
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.
Overactive Bladder With Urge Urinary Incontinence
The purpose of this study is to describe the rates of elevated post void residual (PVR) (defined as \>200mL) in Cincinnati Urogynecology Associates patients following Botox injection, as well as to document how many patients required treatment with clean intermittent self-catheterization (CISC).
Overactive Bladder
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
Overactive Bladder
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Overactive Bladder
Purpose: This is a pilot randomized double-blind placebo controlled trial of anticholinergic or beta-3 agonist medication with or without concomitant probiotic therapy in women initiating medication therapy for overactive bladder (OAB). The aims of this study are to: 1. Explore how concomitant probiotic therapy influences response to medication for OAB in a randomized controlled trial 2. Investigate whether 4 weeks of probiotic therapy alters the urinary microbiome 3. Assess for predictors of response to therapy Participants: Women 18 years of age or older presenting to the Division of Urogynecology and Reconstructive Pelvic Surgery clinic with OAB/UUI or UUI-predominant mixed incontinence who desire nonsurgical therapy will be eligible for participation. Procedures (methods): The study will be conducted over a two-year time frame and the primary outcome will be subjective improvement in symptoms as assessed by the Patient Global Impression of Improvement (PGI-I) validated questionnaire at 4 weeks after initiating anticholinergic or beta-3 agonist medication and study drug. The study aims to recruit up to 140 participants randomized in a 1:1 ratio to either concomitant probiotic or placebo medication.
Overactive Bladder