Last updated: December 6, 2023
Sponsor: Comenius University
Overall Status: Completed
Phase
N/A
Condition
Enuresis
Overactive Bladder
Prostate Disorders
Treatment
Pelvic floor muscle training (PFMT) with suppressive urgency technique
Clinical Study ID
NCT04681625
09072020
Ages > 50 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
• willing to provide written informed consent
- men over 50 years with lower urinary tract symptoms and overactive bladder and benignprostatic hyperplasia
- persistence of overactive bladder despite 4 weeks of silodosin treatment
- symptoms of overactive bladder (urinary frequency and urgency with or without urinaryincontinence) 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-diaryperiod
Exclusion
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 thestudy
- 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 lessthan 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
Study Design
Total Participants: 172
Treatment Group(s): 1
Primary Treatment: Pelvic floor muscle training (PFMT) with suppressive urgency technique
Phase:
Study Start date:
January 11, 2021
Estimated Completion Date:
September 30, 2022
Study Description
Connect with a study center
Jan Svihra
Martin, 03601
SlovakiaSite Not Available
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