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

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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Martin, Slovakia, 03601
    • Jan Svihra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard silodosin treatment; Peroral treatment with silodosin at a dose of 8 mg daily	Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique; Pelvic floor muscle training with suppressive urgency technique: Education about proper urination training in the period without pathological urgency.; Education about conscious urgency suppression through PFMT - suppressive urgency technique.; Education on the principle and effect of PFMT.; Exercises of varying intensity of pelvic floor muscles in different positions.; Exercises to relax the pelvic floor muscles. Exercise 5 times a week for 20-30 minutes a day.
Experimental: Standard silodosin treatment with PFMT; Peroral treatment with silodosin at a dose of 8 mg daily Intervention: Behavioural: Pelvic floor muscle training (PFMT) with suppressive urgency technique	Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique; Pelvic floor muscle training with suppressive urgency technique: Education about proper urination training in the period without pathological urgency.; Education about conscious urgency suppression through PFMT - suppressive urgency technique.; Education on the principle and effect of PFMT.; Exercises of varying intensity of pelvic floor muscles in different positions.; Exercises to relax the pelvic floor muscles. Exercise 5 times a week for 20-30 minutes a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.	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.	over 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower urinary tract symptoms.	To examine changes in the score of lower urinary tract symptoms (LUTS) by the International Prostate Symptom Score (IPSS) in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. 0 = minimum score, 35 = maximum score.	over 12 weeks of treatment
Change in incontinence quality of life .	To examine change in incontinence quality of life by Overactive Bladder Questionnaire (OAB - q) in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. 0 = the worst to 100 = the best quality of life.	over 12 weeks of treatment
Change in patient global impression of improvement	To examine changes in patient global impression of improvement in the combined silodosin and pelvic floor muscle training to silodosin treatment alone . 1 = much better. 7 = definitely worse.	over 12 weeks of treatment
Incidence of adverse events .	To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.	over 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Comenius University
• Investigators: Study Director: Jan Svihra, Prof,MD,PhD, Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak Republic; Study Chair: Magdalena Hagovska, Assoc.pr.PhD, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: overactive bladder; Benign prostatic hyperplasia; silodosin; pelvic floor muscle training
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 09072020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No