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Showing 1-20 of 20 trials
NCT07335484
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
NCT06789406
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
NCT07193407
The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manage symptoms of refractory overactive bladder in adult women aged 18-70 who have not responded to standard treatments. The main questions it aims to answer are: * Is there a clear relationship between bladder nerve activity and patient-reported urgency sensations? * Can targeted stimulation based on bladder nerve activity reduce overactive bladder symptoms? * Is the INO-SNM-01 System safe to use? Researchers will not use a comparison group in this study. Instead, all participants will receive the investigational device to see if it works as intended. Participants will undergo surgery to have a temporary trial lead implanted near the sacral nerve and spend up to 2 days in hospital for monitoring and testing to assess the device sensing and stimulation capabilities. Up to 10 participants will take part in this first-in-human feasibility study at a single site in Australia.
NCT07195656
A study to evaluate the safety and effectiveness of FemPulse System
NCT07391878
This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.
NCT07209397
The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.
NCT07300904
The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.
NCT07030803
The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment. Before inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.
NCT03596671
The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.
NCT07081906
This is a prospective, randomized controlled clinical trial designed to compare the efficacy and safety of transdermal versus oral oxybutynin in children diagnosed with overactive bladder (OAB) who remain symptomatic despite conservative management. A total of 90 children were planned to be enrolled and randomized to receive either oral oxybutynin suspension or a transdermal oxybutynin patch. The primary outcome was defined as the change in Dysfunctional Voiding and Incontinence Symptom Score (DVISS) from baseline to the end of the treatment period. Secondary outcomes included changes in urinary frequency, voided volume, maximum flow rate (Qmax), and the incidence of adverse events. The study aimed to assess whether the transdermal route of administration provides an alternative therapeutic option with favorable tolerability in pediatric OAB patients.
NCT06659536
A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling. The Cefar URO device features four pre-set programs (P1, P2, P3 and P4) and three custom programs. Although supporting data on the preset programs P1, P2, P3 are available for the clinically equivalent UROstim2 device, program P4 is unique to Cefar URO. Program P4 utilizes the parameters 20Hz and 200μs which are commonly reported in the literature for the stated indications but for which no data is available for the clinically equivalent UROstim2 device. The present study is therefore aimed to cover this data gap.
NCT06785558
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
NCT06765629
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence, without urinary tract infection or other clear pathological changes. The prevalence of OAB ranges from 9% to 43% in women and 7% to 27% in men, severely affecting patients' quality of life and mental health. Traditional treatments for OAB include behavioral therapy (bladder retraining, pelvic floor muscle training, etc.) and drug therapy (including anticholinergic, antispasmodic drugs, and tricyclic antidepressants, etc.); for refractory overactive bladder syndrome, surgical interventions include bladder augmentation and urinary diversion, etc. However, due to serious complications, lack of efficacy, or significant trauma, these methods are greatly limited in clinical application. In recent years, with the continuous development of neuromodulation technology, neurostimulation has gradually been applied in the treatment of lower urinary tract dysfunction. Compared with traditional treatments, it does not have side effects such as dry mouth, constipation, blurred vision, etc., and compared with surgical treatment, it reduces side effects such as bleeding and infection. Among them, Tibial Nerve Stimulation (TNS) has become an optional therapy for OAB treatment due to its non-surgical nature, convenience, low risk, high safety, significant efficacy, and relative cost-effectiveness. With the continuous development of technology, and in order to reduce the invasiveness of treatment, improve safety and convenience, Percutaneous Tibial Nerve Stimulation (PTNS) is gradually shifting towards non-invasive Percutaneous Tibial Nerve Stimulation (TTNS). The main difference between the two is that the former uses fine needle electrodes, while the latter mostly uses surface electrodes, which deliver electrical power to the tibial nerve through skin and soft tissue. Studies have shown that TTNS has the same efficacy as drug therapy, is more effective for OAB symptoms than behavioral interventions, and there is no statistically significant difference in efficacy between TTNS and PTNS. It is recommended as an option to improve OAB by the "European Association of Urology Guidelines on Female Non-neurogenic LUTS (2023)" and the "Chinese Guidelines on Diagnosis and Treatment of Urology and Male Diseases (2022)". However, there is still a lack of large-scale prospective studies on the use of TTNS for OAB in Asian populations, and most existing studies have observation periods of 3 months or less, lacking high-quality research evidence for long-term efficacy. Therefore, a prospective, multicenter, single-arm study is planned to verify the long-term efficacy of percutaneous tibial nerve stimulation in the treatment of OAB in the Chinese population.
NCT02216214
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
NCT04562090
The purpose of this study was to evaluate the efficacy of mirabegron for the treatment of overactive bladder (OAB) in Chinese participants. This study also evaluated the safety of mirabegron for the treatment of OAB in Chinese participants, evaluated other efficacy variables of mirabegron for the treatment of OAB and explored different mirabegron starting doses.
NCT03903094
Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.
NCT05211193
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.
NCT02138747
The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.
NCT00507169
The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine
NCT00366002
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.