Status:
COMPLETED
Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder
Lead Sponsor:
Comenius University
Conditions:
Benign Prostatic Hyperplasia (BPH)
Overactive Bladder
Eligibility:
MALE
50+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- • willing to provide written informed consent
- men over 50 years with lower urinary tract symptoms and overactive bladder and benign prostatic hyperplasia
- persistence of overactive bladder despite 4 weeks of silodosin treatment
- symptoms of overactive bladder (urinary frequency and urgency with or without urinary incontinence) for ≥3 months prior to visit 1.
- willing and able to complete the 3-day voiding diary and questionnaires
- International Prostate Symptom Score (IPSS) score ≥8.
- experience an average of 8 or more micturition's per day over the 3-day diary period.
- experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period
- Exclusion criteria:
- post-void residual volume (PVR) \>200 mL
- evidence of Urinary Tract Infection and haematuria
- use anticholinergics, beta 3 mimetics within 4 weeks prior to Visit 1 and during the study
- oncological diseases of the lower urinary tract and prostate
- neurogenic bladder
- urethral strictures and bladder neck stenosis
- urolithiasis
- diabetes mellitus
- previous surgery of lower urinary tract
- stress urinary incontinence
- intermittent catheterisation
- chronic urinary tract infection
- previous botox treatment in the last 12 months
- chronic electrostimulation treatment of OAB in the last 12 months
- patient began or has changed a bladder training program or pelvic floor exercises less than 90 days before 1 visit
- cognitive deficits and dementia
- man has participated in an interventional trial within 30 days prior to Visit 1
- total daily urine production over 2500 mL according to voiding diary
Exclusion
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04681625
Start Date
January 11 2021
End Date
September 30 2022
Last Update
December 7 2023
Active Locations (1)
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1
Jan Svihra
Martin, Slovakia, 03601