Clinical Trial Unit Urology
The department has a professional unit to conduct clinical trials from phase 0 to III. Specialised nurses share the position of clinical trial coordinator / research nurse. We have two patient rooms exclusively available on the outpatient department to see patients participating in the study. All equipment is available to perform all kinds of standard assessments of Urology. In addition, we have equipment for general safety assessments like an ECG available. Phase 0 studies are run in collaboration with the department of Nuclear Medicine and PET research. The collaboration between the department of Urology and that of Nuclear Medicine and PET Research is facilitated by the appointment of the biologist Dr. Geldof at both departments.
The clinical trial unit encompasses an own, protected, archive room for temporarily storage of all essential documents. Electronic versions of documents are stored on a protected part of the internal network. The progress of a study is recorded also using the electronic system. We follow Standard Operation Procedures for both, the clinical and administrative parts of a trial. The set of available SOP's provides the basis for both, the safety of patients and a fast conductance of a trial. Appropriate training of the staff involved in combination with the SOP's does indeed guarantee safety and velocity.
Each clinical trial is lead by an urologist assisted by the staff of the Research Office Urology. The Research Office Urology supported about 40 clinical trials since its start in 2005. The areas of interest are, prostate cancer, bladder cancer, overactive bladder, benign prostatic hyperplasia, erectile dysfunction, hypogonadism, bladder pain syndrome, and hydronephrosis. Complementary pre-clinical research is running for prostate cancer and overactive bladder / bladder pain syndrome.