Clinical trial NCT04681625: Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Overactive Bladder
Keywords: Benign prostatic hyperplasia
overactive bladder
silodosin
pelvic floor muscle training
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 172
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
timeFrame: over 12 weeks of treatment
Secondary outcomes:
measure: Change in lower urinary tract symptoms.
timeFrame: over 12 weeks of treatment
measure: Change in incontinence quality of life .
timeFrame: over 12 weeks of treatment
measure: Change in patient global impression of improvement
timeFrame: over 12 weeks of treatment
measure: Incidence of adverse events .
timeFrame: over 12 weeks of treatment
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: Jan Svihra
Study officials:
affiliation: Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak Republic
name: Jan Svihra, Prof,MD,PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
name: Magdalena Hagovska, Assoc.pr.PhD
role: STUDY_CHAIR
References: