Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT02367404
Brief Summary:
Objectives:
Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.
Secondary:
* Comparison of time to achieve continence between the four arms.
* Comparison of urinary symptoms and quality of life improvement between the four arms.
* Assessment of adverse events in Duloxetine arms.
Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".
Secondary outcome:
* time to achieve continence
* Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
* Urinary symptoms measured with International Prostate Symptom Score (IPSS).
No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.
Statistical methods
* Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
* Comparison of quality of life outcomes between the four arms
* Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).
Study:
NCT02367404
Study Brief:
Protocol Section:
NCT02367404