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An open-label study to assess the pharmacokinetics and safety/tolerability of pulsatile intra-vaginal delivery of a single dose of oxybutynin in healthy females

Primary* To evaluate the pharmacokinetics of oxybutynin and its main hepatic metabolite N-desethyloxybutynin after pulsed intra-vaginal delivery of a single dose of oxybutyninSecondary* To assess the safety and tolerability of the intra-vaginal…

An Open Label, Phase 1/2a Trial to Evaluate the Efficacy, Safety, and Tolerability of KU002 Given as Intravesical Instillations in Subjects with Interstitial Cystitis (IC)/Bladder Pain Syndrome (BPS)*

Primary Objective:The primary objective of this study is to evaluate the safety, tolerability and PK profile following intravesical administration of KU002 in subjects with a diagnosis of BPS/IC.Secondary Objective(s):The secondary objective of the…

Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes.

The purpose of this investigation is to confirm long-term clinical performance and safety of the InterStim Micro System. The primary objectives of the study will evaluate data at 3 months post-implant; however, subjects will be followed for 2 years…

A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder

ObjectivesPrimary* To evaluate the efficacy of mirabegron in children (5 to < 18 years of age) with OABSecondary* To evaluate the efficacy of mirabegron in children (5 to < 18 years of age) with OAB* To evaluate the safety and…

The accuracy of detecting residual disease following neo-adjuvant chemotherapy in patients with
muscle-invasive bladder cancer

To assess whether a complete pathological respons (cPR) after neo-adjuvant chemotherapy can be predicted based on clinical, radiological, and histological variables and on a wide set of tissue and blood/urine (liquid biopsy) biomarkers (DNA/RNA).…

Validation of molecular pathways in urgency urinary incontinence

1) To isolate and cryopreserve human primary bladder muscle and urothelial cells from women with isolated UUI so that we can validate the results from the molecular landscape in vitro.2) To collect and store human bladder biopsy tissues from women…

A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

This study has been transitioned to CTIS with ID 2023-503500-87-00 check the CTIS register for the current data. This study is designed to assess the antitumor efficacy and safety of pembrolizumab + CRT following maximal TURBT compared with placebo…