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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH); Overactive Bladder
• Interventions: Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique

• Registration Number: NCT04681625
• Lead Sponsor: Comenius University

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.

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-23
• Study Start: 2021-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 172

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.	over 12 weeks of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Change in patient global impression of improvement	over 12 weeks of treatment	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.
Change in incontinence quality of life .	over 12 weeks of treatment	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.
Incidence of adverse events .	over 12 weeks of treatment	To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.
Change in lower urinary tract symptoms.	over 12 weeks of treatment	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.

Trial Locations

Locations (1)

Jan Svihra; 🇸🇰 Martin, Slovakia