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An open-label, two-way cross-over, randomized study to assess the pharmacokinetics and safety/tolerability of intra-vaginal delivery of gonadorelin and oxybutynin in healthy female volunteers

1. To explore the pharmacokinetics (PK) of intra-vaginal delivery of gonadorelin and oxybutynin. 2. To assess the safety and tolerability of gonadorelin and oxybutynin delivery with a prototype intra-vaginal ring.

Predicting factors for postoperative urinary retention: a prospective study

Primary objective: to study potential risk factors for post-operative urinary retentionsecundary objective: construction of a risk calculator to identify patients at risk for post-operative urinary retention

Size and volume charts of fetal bladder during the second and third trimester of pregnancy

The main objective of the study is to construct reference curves for fetal bladder diameters and volume in the second and third trimester of pregnancy. Moreover we will investigate the variation in the dimensions of renal pelvis in relation to the…

Urodynamic changes after placement of the NeoTract® UroLift® System

The purpose of this study is to measure changes in urodynamic parameters during pressure flow studies before and after the UroLift treatment and try to identify which of these parameters may be responsible for the symptomatic response. We…

Time of onset and time of offset of sacral neuromodulation effect.

The main objective is to evaluate the average time span within which *time of onset* and *time of offset* occurs in patients with overactive bladder syndrome or non-obstructive urinary retention who respond to SNM.

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…

A Phase 2, single-arm study of bempegaldesleukin (NKTR-214) in combination with nivolumab in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients

The primary objective is:• To evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per…

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…

Generation of urothelial cancer organoids to investigate tumor biology in organoids and to perform drug sensitivity testing.

Primary objective:To establish and propagate a bladder cancer / immune cell co-culture model to study patient response to immunotherapy ex vivo. (Can organoid and immune cell co-cultures be maintained for 3 passages?) Protocols will be improved…

Pre-BladParadigm - the effect of diagnostic transurethral bladder tumor resection (TURBT) on the level of circulating tumor cells (CTCs) in the blood of patients suspected of muscle invasive bladder cancer

To validate the suggestion that transurethral resection of bladder tumors in patients with suspected muscle invasive bladder cancer can lead to circulating tumor cells.

Clinical Study of Neuspera*s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI)

Primary Efficacy objective: The purpose of the study is to test the efficacy of the Neuspera Implantable SNS System for treatment of urinary urgency incontinence Primary safety objective: The primary safety objective of the study is to assess the…

A prospective study to assess the efficacy and safety of the BlueWind RENOVA iStim* System for the treatment of patients diagnosed with overactive bladder (OASIS - OverActive bladder StImulation System study)

To demonstrate efficacy and safety of the treatment of UUI with BlueWind RENOVA iStim* System therapy.

A Phase 1b-2 study of Mitomycin-C / Capecitabine chemoradiotherapy combined with Ipilumimab and Nivolumab or Nivolumab monotherapy as bladder sparing curative treatment for muscle Invasive bladder Cancer: the CRIMI study.

This study has been transitioned to CTIS with ID 2023-509460-19-00 check the CTIS register for the current data. *In the phase Ib study: to assess the feasibility and safety of the addition of nivolumab and/or ipilimumab to MMC/capecitabine…

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Primary Objectives:Associated pharmaceutical trial:To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as first-line treatment in subjects with advanced UC that expresses HER2Clinical performance study:To…

Confocal Laser Endomicroscopy before transurethral resection for optimizing Bladder Cancer diagnosis and treatment.

Primary objectives: This study is two-fold and, therefore, has two primary objectives:1. Investigating the diagnostic accuracy of CLE (Cystoflex*F probe) during flexible cystoscopy for diagnosis and grading of urothelial carcinoma of the bladder.2.…

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…

Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study

Primary Safety Objective: • To evaluate initial safety of UCon for treatment of OAB symptoms in a home setting.Secondary Safety Objective• To demonstrate that subjects using UCon do not experience an unacceptable amount of device- or procedure…

Expression of prostate specific membrane antigen (PSMA) in soft tissue sarcomas and urothelial cell carcinomas: implications for tumour-specific molecular imaging and treatment?

This pilot study aims to investigate the PSMA expression in the biopsy material of advanced soft tissue sarcomas and advanced urothelial cell carcinomas, and in case of high PSMA expression, to investigate whether this correlates with high tracer…

An observational, non-interventional cohort study to monitor physical and social activity of bladder cancer patients during treatment with curative intent by using conventional and digital methodology

PrimaryTo determine the feasibility of monitoring bladder cancer patients with the Trial@home platform.SecondaryTo correlate social, physical, and physiological data of bladder cancer patients collected from the Trial@home platform with the quality-…

A nationwide multicentre, open-label study of six months avelumab maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after at least 4 cycles of first-line platinum-containing chemotherapy and the opportunity to re-treat

This study has been transitioned to CTIS with ID 2024-512975-11-01 check the CTIS register for the current data. To demonstrate benefit of maintenance treatment with avelumab for a maximum of six months avelumab in increasing overall survival (OS)…