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Showing 1-20 of 73 trials
NCT03258593
Background: Non-muscle-invasive bladder cancer is in the early stages. But it usually comes back after treatment. The drugs Vicineum and Durvalumab may help the immune system find and destroy cancer cells. Objective: To test if the drugs Durvalumab and Vicineum together are safe and effective to treat people with bladder cancer that has not spread to the muscle in the bladder. Eligibility: People ages 18 and older who have bladder cancer that has not spread to the muscle in the bladder and was treated unsuccessfully with Bacillus Calmette-Guerin Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Tumor sample from previous surgery. If one is not available, they will have a biopsy: A small piece of tumor is removed. Cystoscopy to examine the inside of the bladder. This may include a biopsy or removing tumors. Computed tomography (CT) or magnetic resonance imaging (MRI): They lie in a machine that takes pictures of the body. Electrocardiogram to test heart function Participants will receive Durvalumab and Vicineum in 2 phases: First phase: Durvalumab every 4 weeks and Vicineum once a week for 3 months Second phase: Durvalumab every 4 weeks and Vicineum once every other week Participants will have tumor samples taken every 3 months. They will have blood and urine tests throughout the study. Participants will continue treatment for up to 2 years. Participants will have a visit about 30 days after their last treatment. This includes blood and urine tests. It may include a cytoscopy or additional biopsies.
NCT07222488
Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.
NCT03459846
A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
NCT07366918
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of IVES vs perineal ES in women with idiopathic OAB. The main questions aimed to be answered are: Is Intravaginal Electrical Stimulation (IVES) or perineal ES more effective on clinical parameters related to incontinence and quality of life in women with idiopathic overactive bladder (OAB)? Participants (n:63) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 3 groups using a randomization table. The first group will receive IVES and bladder training (n:21), second group will receive perineal ES and bladder training (n:21) and third group will receive bladder training (n=21) . Measurements will be performed twice in total, before and at the end of treatment (8th week).
NCT06818136
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
NCT07347132
Bladder cancer that has not invaded the bladder muscle often returns after treatment, creating repeated procedures and ongoing anxiety for patients. The standard initial treatment is transurethral resection of bladder tumour (TURBT), in which visible tumours are removed through a telescope passed into the bladder. Conventional TURBT usually removes the tumour in multiple pieces, which may reduce specimen quality for laboratory assessment and may increase the chance that small tumour fragments remain or spread during removal. En bloc TURBT is a newer technique that aims to remove the tumour in one intact piece, which may improve the quality of the tissue specimen for accurate staging and grading, allow better assessment of surgical margins, and potentially reduce recurrence. This randomized controlled trial was conducted in the Department of Urology, Lahore General Hospital and PGMI, Lahore. A total of 116 adults (18 to 60 years) with non-muscle invasive bladder cancer were enrolled and randomly assigned to en bloc TURBT or conventional TURBT (58 patients per group). Resected specimens were evaluated by pathologists who was not be informed of the surgical technique. The study was compare key pathological outcomes, including the presence of detrusor muscle in the specimen, histological grade, tumour stage accuracy, specimen integrity, and the ability to assess lateral and deep resection margins. Participants were followed for 15 months, with surveillance at 3-month intervals.
NCT05614739
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.
NCT01558856
The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.
NCT05014139
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
NCT06822010
This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.
NCT05232253
The investigators have developed a novel pressure monitoring device called a 'cystoelastometer' that connects to a drainage end ofastandard urinary catheters that are used by patients with a neurogenic bladder on daily clean intermittent catheterization. The device has already been demonstrated to be accurate in measuring bladder pressure compared to the gold standard urodynamics that are performed in the clinic or hospital. This study will assess the patients and care givers ability and experience using the cystoelastometer device in a home setting.
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.
NCT06237920
This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment
NCT03081858
This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder. Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established). Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary papillary tumor. Part 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine rates of disease-free survival.
NCT06933407
Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations. This prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs): * internal urethral orifice (IUO) level * midurethra (MU) level * external urethral orifice (EUO) level The adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region. Descriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups. It is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls. Pathophysiological focus: The study will explore key mechanisms underlying SUI, including: * Weakened bladder neck support * Impaired urethral stabilization due to increased tissue elasticity and collagen degradation * While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods. Standardization and Protocol The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include: * Minimal probe compression during introital ultrasound to avoid artifacts * Bladder emptying prior to examination to eliminate confounding effects * Carefully standardized ROI placement across all patients * Controlled image acquisition conditions to reduce variability Future Directions * Future research based on this study will aim to: * Optimize SE protocols and refine ROI placement strategies * Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women * Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics * Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI
NCT06336304
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
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.
NCT04576286
En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence
NCT03456089
The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.
NCT01565707
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.