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

NCT04681625 | Completed

• 1 other identifier: 09072020
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH); Overactive Bladder

Keywords

Benign prostatic hyperplasia; overactive bladder; silodosin; pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in lower urinary tract symptoms.

  over 12 weeks of treatment

• Change in incontinence quality of life .

  over 12 weeks of treatment

• Change in patient global impression of improvement

  over 12 weeks of treatment

• Incidence of adverse events .

  over 12 weeks of treatment

Study Arms (2)

Standard silodosin treatment

ACTIVE COMPARATOR

Peroral treatment with silodosin at a dose of 8 mg daily

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

Standard silodosin treatment with PFMT

EXPERIMENTAL

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

Interventions

Pelvic floor muscle training (PFMT) with suppressive urgency technique BEHAVIORAL

Pelvic floor muscle training with suppressive urgency technique: 1. Education about proper urination training in the period without pathological urgency. 2. Education about conscious urgency suppression through PFMT - suppressive urgency technique. 3. Education on the principle and effect of PFMT. 4. Exercises of varying intensity of pelvic floor muscles in different positions. 5. Exercises to relax the pelvic floor muscles. Exercise 5 times a week for 20-30 minutes a day.

Standard silodosin treatment; Standard silodosin treatment with PFMT

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

Jan Svihra

Martin, 03601, Slovakia

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Svihra, Prof,MD,PhD

  Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak Republic

  STUDY DIRECTOR

• Magdalena Hagovska, Assoc.pr.PhD

  Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 23, 2020
• Study Start: January 11, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)