Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder (SILODOSING)

Comenius University

Status: Completed

Conditions: Benign Prostatic Hyperplasia (BPH); Overactive Bladder

Treatments: Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04681625

09072020

Details and patient eligibility

About

This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.

Full 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.

Enrollment: 172 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Standard silodosin treatment

Active Comparator group

Description:

Peroral treatment with silodosin at a dose of 8 mg daily

Treatment:

Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique

Standard silodosin treatment with PFMT

Experimental group

Description:

Peroral treatment with silodosin at a dose of 8 mg daily Intervention: Behavioural: Pelvic floor muscle training (PFMT) with suppressive urgency technique

Treatment:

Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique