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PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER

- To evaluate the bladder-preservation rate after chemoradiation - To evaluate the toxicity and complications of treatment with induction chemotherapy followed by ePLND and chemoradiation

A randomized, double blind, placebo controlled phase II trial to evaluate the safety and efficacy of recMAGE-A3 + AS15 ASCI in patients with MAGE-A3 positive muscle invasive bladder cancer after cystectomy

The primary objective of this Phase II study is to evaluate the clinical efficacy in terms of Disease Free Survival of recMAGE-A3 + AS 15 ASCIversus placebo in the overall population.Secondary objectives are:• To evaluate overall survival in the…

A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder

Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…

Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium

Primary objective:· To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations.…

A Pilot, Multicenter, Double-blind, Placebo-controlled, Dose-escalation Study of the
Safety and Efficacy of AGN-214868 in Patients with Idiopathic Overactive Bladder and
Urinary Incontinence

The objectives of this study are to evaluate the safety and efficacy of AGN-214868 compared with placebo in the treatment of patients with IOAB and urinary incontinence.The clinical hypotheses for this study are:• AGN-214868 has an acceptable safety…

Evaluating the Effect of Pre-TURBT Intravesical Instillation
of Mitomycin C (MMC) Mixed With TC-3 Gel
in Patients with Non Muscle Invasive Bladder Cancer (NMIBC)

Evaluation of the effect of pre-TURBT intravesical instillations of MMC mixed with TC-3 Hydrogel on bladder lesion(s) of NMIBC patients.a. Comparison of the effect of pre-TURBT instillations with MMC mixed with TC-3 Hydrogel on bladder lesion(s) to…

A RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED, 5-WAY, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ONO-8539 IN PATIENTS WITH OVERACTIVE BLADDER

The primary objective of this trial is to compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24 hrs from baseline to 12 weeks.The secondary objectives of this trial will be:*To…

Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/
Interstitial Cystitis.

To describe the course of symptoms of BPS/IC after intravesical injection of Botox®.

Randomized, double-blind, placebo-controlled, parallel group study of vardenafil 10 mg twice daily to assess the effect on urodynamics in patients with Overactive Bladder (detrusor overactivity).

To determine the therapeutic effect of vardenafil 10 mg taken twice daily (BID) on Overactive Bladder by means of urodynamic measurements (filling cystometry and pressure flow investigations).

Performance of the miniaturo*-I system for treatment of urinary urge incontinence.

To determine the performance (safety and effectiveness) of miniaturo*-I for the treatment of urinary urge incontinence.

A Phase II, international, multi-centre, prospective, randomised, parallel-group, double-blind, dose-ranging, placebo-controlled, 12-week, princeps study to assess the efficacy and safety of a one injection cycle with either botulinum toxin type-A (Dysport® 125, 250 or 500 units) or placebo followed by an optional 6-month extension phase in the symptomatic treatment of micturition urgency and frequency in continent female subjects suffering from idiopathic overactive bladder.

Primary Objective: To assess the effect of treatment with three doses of botulinum toxin type-A (Dysport®) versus placebo on the number of episodes of urgency and frequency of micturition experienced in continent female subjects with idiopathic…

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects with Idiopathic Detrusor Overactivity

To evaluate the urodynamic effects, the safety and tolerability and the clinical efficacy of AV608 compared with placebo in subjects with idiopathic detrusor overactivity

A Multicentre, Placebo Controlled, Randomised, Double-blind, Dose Ranging Study of SVT-40776 0.05 mg, 0.1 mg, 0.2 mg, Tolterodine 4 mg and Placebo Daily Doses for 4 Weeks in Patients Suffering from Overactive Bladder Syndrome

To evaluate the dose-response relationship of SVT-404776 on efficacy.

A randomized, double-blind, placebo-controlled, parallel-group, multi-centre, Phase IIb, study to determine the effect of BXL628 in women with detrusor overactivity

the primary objective is to evaluate the effect of BXL628 on the bladder volume at the first involuntary contraction following 4 weeks of treatment; the secondary objectives are to determine the effect of BXL628 on symptom severity measured by a…

A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis

To investigate efficacy of ASP6294 in female subjects with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC).To investigate safety and tolerability of ASP6294 in female subjects with BPS/IC.To investigate the pharmacokinetics and pharmacodynamics…

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).

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…

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2a, Proof-of-Concept Study of ASP8302 in Subjects with Underactive Bladder

•To evaluate the efficacy of ASP8302 compared with placebo in subjects with Underactive Bladder (UAB)•To investigate the safety and tolerability of ASP8302 compared with placebo in subjects with UAB•To investigate the pharmacokinetics of ASP8302 in…