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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Overactive Bladder, Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard silodosin treatment<br>Peroral treatment with silodosin at a dose of 8 mg daily | Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique<br>* 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.<br>|
| Experimental: Standard silodosin treatment with PFMT<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, overactive bladder, silodosin, pelvic floor muscle training