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About
The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.
Full description
A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.
2 groups:
The randomization will be stratified on the radiotherapy dose (1 to 40 Gy or 40 to 70/80 Gy).
Screening:
For all patients, OAB items of the USP scale will be completed before each standard weekly assessment during prostate radiotherapy. Patients who reach an OAB sub-score greater to 5 will be addressed to an urologist in order to confirm absence of Qmax < 10ml/sec at initial assessment, or post-void residual urine > 100 milliliter (ml).
Inclusion & treatment:
A week at most after pre-screening, patients will be randomized to receive either Vesicare®-5mg or a placebo. In both study arms, the treatment should be continued for 3 months.
Follow-up:
The radiation oncologist will perform patients' follow-up for the study at the treatment initiation, 6 weeks and 3 months after start of the treatment (Vesicare or placebo).
The questionnaires for the evaluation of OAB syndrome, acute urinary toxicity and quality of life should be completed for each follow-up visit. The voiding diary will be completed during 3 days before (or if not, 3 days after) all the evaluation times.
An urologist will perform an uroflowmetry and a post-voiding echography (or a bladder scan) before initiation of the treatment, and after 6 weeks of treatment.
Statistics and sample size PATIENTS ENROLMENT 70 patients will be included (considering 66 patients completing the full study) within 3 recruitment centers
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4 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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