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The efficacy of an antigenic marker lesion for the therapeutic effect in patients with multiple, Ta/T1, G1/G2, non-muscle invasive bladder cancer (NMIBC) treated with TUR followed by IL-2 instillation

We like to demonstrate that treatment of non-muscle invasive bladder carcinoma with incomplete TUR and IL-2 is therapeutically more effective than treatment with complete TUR and IL-2.

A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Objective: The principal objective is To evaluate the long-term safety and maintenance of efficacy of BOTOX® (200 U) injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have…

An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)

To evaluate the safety and efficacy of solifenacin succinate suspension once daily in children and adolescents with OAB.

a phase III randomised trial of intravesical chemotherapy vs thermo-chemotherapy in intermediate risk non-muscle invasive bladder cancer

To compare standard treatment with intravesical chemotherapy with loco-regional thermo-chemotherapy in patients with an intermediate risk non-muscle invasive urothelial carcinoma of the bladder after complete transurethral resection of the tumour(s…

The Global randomized NBi bladder cancer study
A Multi-Centre, International study to compare the use of Narrow Band Imaging (NBI) versus White light (WL) to assess recurrence of bladder cancer in terms of safety and efficacy.

To compare the recurrence rate at 1 year following Narrow Band Imaging and TURB (Arm A) with White Light Trans Urethral Resection of Bladder cancer (TURB) (Arm B) in patients with bladder cancer (NMIBC).The purpose of this study is to investigate…

A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

To evaluate the efficacy, safety and PK of solifenacin succinate suspension after multiple dose administration.

Transurethral Ultrasound directed Injection of autologous Myoblasts, Fibroblasts and Collagen for the treatment of urinary incontinence

The objective of the study is to ascertain whether the high effect sizes obtained in the previous studies can be explained according to our working hypothesis, i.e. whether the intervention with Urocell is associated with a structural regeneration…

BioXmark liquid fiducial markers for image guided radiotherapy in bladder cancer, a safety and performance trial

This study will evaluate usability, safety and performance of a cystoscopic guided injection of a marker (BioXmark) at the tumor site in patients with bladder cancer on planning CT and CBCT during the irradiation period.

A Phase III Randomized, Open-Label, Multicenter Study to Determine the
Efficacy and Safety of Durvalumab in Combination With Tremelimumab
and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab
Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or
Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive
Bladder Cancer (VOLGA)

This study has been transitioned to CTIS with ID 2023-507342-84-00 check the CTIS register for the current data. (1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC…

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)

This study has been transitioned to CTIS with ID 2023-507187-39-00 check the CTIS register for the current data. The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk…

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

The current study is designed to evaluate the safety and efficacy of combination therapy with pembrolizumab + lenvatinib versus pembrolizumab + placebo in cisplatin-ineligible participants whose tumors express PD-L1 (CPS >=10) and…

A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

The primary objective of this study is to evaluate efficacy of erdafitinib versus chemotherapy orpembrolizumab in subjects with advanced urothelial cancer harboring selected FGFR aberrations whohave progressed after 1 or 2 prior treatments, at least…

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…

A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

This study has been transitioned to CTIS with ID 2022-501784-40-00 check the CTIS register for the current data. The study aims to demonstrate that treatment with nivolumab combined with ipilimumab will improve efficacy in cisplatin-ineligible…

Prospective, non-randomized, multicentre clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)

The objective of this trial is to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. The only notable difference between the existing,…