NCT04681625
Completed
Not Applicable
Randomised Intervention Multicentre Study to Evaluate the Effect of Pelvic Floor Muscle Training in Men With BPH and OAB Treated With Silodosin - The SILODOSING Study
Comenius University1 site in 1 country172 target enrollmentJanuary 11, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Sponsor
- Comenius University
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.
Detailed Description
This is a randomised-intervention, parallel, multicentre study which will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with silodosin.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
Time Frame: over 12 weeks of treatment
The investigators will compare change in the number of voidings and the intensity of urgencies during 24 hours in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.
Secondary Outcomes
- Change in patient global impression of improvement(over 12 weeks of treatment)
- Change in incontinence quality of life .(over 12 weeks of treatment)
- Incidence of adverse events .(over 12 weeks of treatment)
- Change in lower urinary tract symptoms.(over 12 weeks of treatment)
Study Sites (1)
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