Overactive Bladder

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

This research aims to assess the long-term safety and effectiveness of the FDA-approved eCoin4 implanted tibial nerve stimulator in people with overactive bladder (OAB) who experience urgency urinary incontinence (UUI). The study is prospective, involves multiple centers, and follows a single group of participants to understand how the device performs in real-world use. Participants will receive an implant of the eCoin device, which provides subcutaneous stimulation to the tibial nerve. This stimulation is intended to help manage urgency urinary incontinence. The treatment involves implanting the device and then monitoring participants over time to evaluate its safety and effectiveness. Throughout the study, participants will complete voiding diaries and quality of life questionnaires during follow-up visits that extend up to 5 years. Researchers will monitor safety by tracking any device- or procedure-related adverse events and measure effectiveness by assessing responder rates at 12 and 24 months. The study includes ongoing evaluations of safety data even after reimplantation when applicable, ensuring comprehensive long-term monitoring.

Researchers are evaluating whether intravenous magnesium can help treat bladder spasms that occur after urologic surgery. This Phase 2 clinical trial compares magnesium infusion to a placebo in adults undergoing bladder invasive procedures, aiming to better understand its impact on post-operative bladder spasms. Participants will be randomly assigned to receive either an intravenous magnesium infusion or an equivalent volume of normal saline (placebo) during their urologic surgery. The magnesium dose includes a loading infusion of 50 mg/Kg followed by 15 mg/Kg per hour. The study is quadruple-masked to keep participants and researchers unaware of the assigned treatment during the surgery. During the study, researchers will monitor the incidence and severity of bladder spasms approximately 1 and 4 hours after surgery. They will also assess treatments used for spasms and patient satisfaction about 4 hours post-operation. The trial involves outpatient procedures and aims to complete by the end of 2026, with careful safety and effectiveness monitoring throughout.

Researchers are evaluating the safety, effectiveness, and how the body processes the drug vibegron in children aged 2 to less than 18 years who have neurogenic detrusor overactivity (NDO) and who regularly use clean intermittent catheterization (CIC). This study includes pediatric participants with NDO due to conditions like spinal dysraphism or acquired causes and aims to gather long-term safety and efficacy data. Participants are divided into two groups based on age: those aged 12 to less than 18 years and those aged 2 to less than 12 years. Both groups receive vibegron orally once daily, with doses adjusted according to weight and individual responses, including possible dose reductions up to two times. The study includes two parts: Part A involves initial dosing and monitoring, while Part B administers a dose selected by a safety board based on Part A data. Throughout the study, participants will be monitored with various assessments including bladder function tests, catheterized urine volume measurements, and questionnaires about incontinence and symptoms. These evaluations occur at multiple time points up to 52 weeks, with the primary outcome focused on changes in bladder capacity at 32 weeks. Safety and tolerability are also closely followed during the study, which may last several months for each participant.

Researchers are studying surgical preparedness in Latinas undergoing urogynecologic surgery to develop and test a telehealth intervention called TIPPS-Latina. The study aims to understand factors affecting preparedness, design a patient-centered intervention using Human Centered Design and Dissemination & Implementation methods, and pilot test the intervention for feasibility and implementation. This project involves a participatory action framework guiding all study phases. Participants scheduled for urogynecologic surgery will be randomly assigned to receive either routine preoperative counseling alone or routine counseling plus the TIPPS-Latina telehealth intervention. The intervention development follows a three-phase Discover, Design/Build, and Test framework, using mixed methods to refine and evaluate the telehealth support tailored for Latinas. The study includes community patient partners to guide research and intervention design. Participants will complete assessments including the Surgical Preparedness Assessment, health literacy, self-efficacy, trust in provider, decisional conflict, anxiety/depression, and satisfaction with healthcare services. These are measured at preoperative visits, on the day of surgery before the procedure, and 6-8 weeks postoperatively. The study evaluates the intervention's feasibility, acceptability, and appropriateness during preoperative holding on surgery day, with monitoring of implementation outcomes and patient-reported measures over the course of the trial.

Researchers are evaluating the use of the ZIDA Control Sock, an FDA-cleared, noninvasive wearable device that delivers mild electrical stimulation near the ankle, as an additional treatment for adults with overactive bladder (OAB) who continue to have symptoms despite stable medication. The study focuses on adults diagnosed with OAB-wet, which includes urgency urinary incontinence, to assess the device's effects alongside their usual pharmacologic therapy. Participants will use the ZIDA Control Sock at home once a week for 12 weeks while continuing their prescribed OAB medication. The device stimulates peripheral nerves involved in bladder control through low-level electrical signals. The study is a single-arm clinical investigation that includes participant training, remote support for proper device use, and safety monitoring during the treatment period. Throughout the study, participants will complete bladder diaries, questionnaires, and attend follow-up visits. Researchers will collect clinical and patient-reported information to measure changes in daily urgency urinary incontinence episodes and other bladder symptoms. Safety will be monitored, and device usability and patient impressions of improvement will be evaluated. The study duration is 12 weeks with ongoing assessment of device-related effects.

Researchers are studying the use of the Victo adjustable artificial sphincter to treat male patients who have urinary incontinence following prostate surgery. This prospective academic study aims to evaluate how well the device works and its safety in managing severe incontinence in this group. This non-interventional study includes adult males who have already undergone implantation of the Victo artificial sphincter. Before surgery, patients receive standard diagnostic tests. After activation of the device, they will have follow-up visits at 3 months and then annually. Patients can also contact the study center at any time if their symptoms worsen or if they face any complications. During the study, participants will complete tests such as the 24-hour pad-weight test to measure incontinence severity and patient questionnaires about their improvement. Researchers will follow patients for up to 5 years to assess treatment outcomes and safety. The total participation time varies based on follow-up but involves regular monitoring and the opportunity to report issues anytime.

Researchers are evaluating the Adjustable Continence Therapy (ACT) device for women with stress urinary incontinence caused by intrinsic sphincter deficiency. This prospective, single arm, non-randomized, multicenter trial aims to assess the safety and effectiveness of ACT in providing meaningful improvement in symptoms for affected women. The study is sponsored by Uromedica and focuses on clinical outcomes related to urinary incontinence. The trial involves implanting two ACT devices in each participant in the paraurethral space near the bladder neck using local, spinal, or general anesthesia. The device includes balloons that are filled with an isotonic solution after implantation via subcutaneous ports placed in the labia majora. This device implantation is the main intervention studied, and participants receive follow-up care to monitor results. Participants will undergo evaluations including provocative pad weight measurement at 12 months to assess urine leakage. Additional assessments include quality of life and urogenital distress questionnaires at 12 months. Researchers will also monitor participants for safety and treatment adherence throughout the study. The trial seeks to gather comprehensive data on symptom improvement and quality of life over the course of a year following device implantation.

Researchers are evaluating the safety and performance of the Glean Urodynamics System for monitoring the lower urinary tract. This prospective, open-label, single-arm interventional trial focuses on both in-clinic and extended monitoring periods. The study aims to assess how well this device works in clinical settings and during continued use outside the clinic. Participants will have the Glean Urodynamics System inserted, which includes a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software applications. Initially, monitoring occurs in-clinic, followed by discharge with the bladder sensor in place for up to 24 hours of additional monitoring at home. The sensor is removed within 24 hours after insertion. Seven days following sensor removal, participants provide a urine sample and receive a follow-up phone call 14 days after the device is removed. During the study, participants will undergo monitoring with the device and provide a urine sample after one week. Researchers will track any adverse events related to the Glean Urodynamics System from the time of enrollment until 14 days after device removal. Follow-up phone calls help ensure participant safety and gather additional information. Participation duration includes the initial monitoring period, sample collection, and follow-up, lasting a few weeks in total.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.