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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 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.

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…

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 randomised controlled trial comparing physiotherapy to electromagnetic stimulation for urinary incontinence

Primary objective:Subjective improvement of urinary incontinence (PGI-I)Secondary objectives:Objective (using stress test, padtest, bladder diaries, Sandvik score) and subjective cure of incontinence (questionnaires)Complicaties en de novo…

A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms.

Primary Objective is to evaluate the efficacy of solifenacin 5mg in combination with mirabegron 50mg (referred to as combination therapy from here on) versus solifenacin 5mg monotherapy.Secondary Objectives are:- To evaluate the safety and…

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 randomized controlled trial of anterior colporraphy and PerigeeTM as surgical correction of symptomatic cystocele.

To study which technique is most effective to surgically correct a symptomatic cystocele.2. To compare morbidity and post-operative recovery of anterior colporraphy and PerigeeTM.3. To compare the need for repeated pelvic floor surgery following…

Bladder training with or without PTNS(Posterior Tibial Nerve Stimulation) in the treatment of Overactive Bladder

The main objective of this study will be to assess whether an additive stimulation of the posterior tibial nerve (PTNS) in combination with bladder training has a significant reduction in frequency of micturition in patients with overactive bladder…

One day versus three day suprapubic catheterisation after vaginal prolapse surgery: a randomized controlled trial.

To determine the optimal moment to start bladder training after vaginal prolapse surgery with anterior colporrhaphy.

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder

Primary objective:* To evaluate the safety and tolerability of long-term combination treatment with solifenacin (5 mg)with mirabegron (50 mg) compared to solifenacin and mirabegron monotherapySecondary objectives:* To evaluate efficacy of long-term…

A RANDOMIZED, TWO-PERIOD, OPEN-LABEL, SINGLE DOSE CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF AQX-1125 IMMEDIATE RELEASE TABLETS AND CAPSULES IN HEALTHY VOLUNTEERS

The purpose of the study is to investigate how quickly and to what extent AQX 1125 in the tablet form and the capsule form are absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of AXQ 1125 after…

Functional near-infrared spectroscopy as biofeedback to assist pelvic floor muscle training: a randomized controlled trial.

The main aim is to study whether fNIRS is a reliable non-invasive alternative to invasive pelvic floor EMG in order to provide biofeedback during pelvic floor physical therapy in patients with SUI.

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 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…

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 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B

This study has been transitioned to CTIS with ID 2023-506385-30-00 check the CTIS register for the current data. Primary Part 1:-To evaluate ORR in participants treated with MK-4280A plus EV (Arm A), MK-7684A plus EV (Arm B), and pembrolizumab plus…

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…

The IMAGE1 S* Non-Muscle-Invasive bladder cancer study:
A multicenter international randomized controlled study to compare the outcome using the IMAGE1 S* System versus White Light Imaging (WLI) during TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).

To compare the recurrence rate of tumor at 12 months following IMAGE1 S* assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B) in patients with primary or recurrent non-muscle-invasive urothelial bladder cancer (NMIBC Ta/T1/CIS…