Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Overactive Bladder
  • Urinary Incontinence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

The design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control. The size of the sample will be 56 participants who come to referral hospitals. They will be randomized in two groups: control or experimental. The variables of the study will be collec...

The design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control. The size of the sample will be 56 participants who come to referral hospitals. They will be randomized in two groups: control or experimental. The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention. The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05

Tracking Information

NCT #
NCT04120545
Collaborators
Not Provided
Investigators
Principal Investigator: Aníbal Báez-Suárez, PhD University of Las Palmas de Gran Canaria