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

Last updated: December 6, 2023
Sponsor: Comenius University
Overall Status: Completed

Phase

N/A

Condition

Enuresis

Overactive Bladder

Prostate Disorders

Treatment

Pelvic floor muscle training (PFMT) with suppressive urgency technique

Clinical Study ID

NCT04681625
09072020
  • Ages > 50
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion criteria:

• willing to provide written informed consent

  • men over 50 years with lower urinary tract symptoms and overactive bladder and benignprostatic hyperplasia
  • persistence of overactive bladder despite 4 weeks of silodosin treatment
  • symptoms of overactive bladder (urinary frequency and urgency with or without urinaryincontinence) 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-diaryperiod

Exclusion

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 thestudy
  • 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 lessthan 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 Design

Total Participants: 172
Treatment Group(s): 1
Primary Treatment: Pelvic floor muscle training (PFMT) with suppressive urgency technique
Phase:
Study Start date:
January 11, 2021
Estimated Completion Date:
September 30, 2022

Study 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.

Connect with a study center

  • Jan Svihra

    Martin, 03601
    Slovakia

    Site Not Available

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