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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

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 Randomized, Double-Blind, Parallel-Group, Placebo- and Active-
Controlled, Multi-center Study to Evaluate the Efficacy, Safety and
Tolerability of Combinations of Solifenacin Succinate and Mirabegron
Compared to Solifenacin Succinate and Mirabegron Monotherapy in the
Treatment of Overactive Bladder

Primary objective *To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron compared to solifenacin and mirabegron monotherapySecondary objectives*To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron…

Acute effect on urodynamic measurements of sacral neuromodulation for treatment of idiopathic overactive bladder.

The aim is to determine the immediate effect of sacral neuromodulation on urodynamic measurements.

BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB) ) * amendment to allow extended follow up of the patients

To evaluate BlueWind Medical RENOVATM System safety and performance in OAB patients for extended FU period of 36 months.

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 Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy

To assess the efficacy of Mirabegron 50mg versus Solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.

Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study.

- Can early Botox-injections in the bladder of patients with meningomyelocèle (MMC) prevent deterioration of the bladder and renal function?- Can early Botox-injections in the bladder of patients with meningomyelocèle (MMC) decrease the need for an…

Intermittent sacral neuromodulation for treatment of idiopathic overactive bladder in women

The aim is to elongate the service life of the implantable neurostimulator while achieving a minimal improvement of 50% of the symptoms of 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…

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.…

Prevention of Acute Radiation cystitis by using Intra-vesical chondroitin Sulphate.

The primary objective of this study is to evaluate whether preventive intravesical instillations with 0.2% chondroitin sulphate solution reduce bother related to acute radiation cystitis symptoms patients undergoing pelvic radiotherapy.

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 multi- center, randomized, cross-over study to demonstrate the efficacy of pudendal neuromodulation for the treatment of neurogenic overactive bladder

The purpose of this trial is to demonstrate the superior efficacy of pudendal neuromodulation in treating patients with neurogenic overactive bladder, who have failed conservative treatment, in a randomized cross-over trial.Symptoms of urinary…

A phase I dose escalation study of intravesical TMX-101 in subjects with Non-Muscle-Invasive Bladder Cancer

The primary objectives are the following:- To assess the safety profile and determine the Optimal Biological Dose (OBD) or Maximum Tolerated Dose (MTD), whichever occurs first, of intravesically administered TMX-101. The secondary objectives are the…

Phase I trial evaluating combined radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder

This study is a phase I trial. Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer. Secondary objectives are to investigate the efficacy of combined radiotherapy…

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…