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

NCT ID: NCT04681625

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2022-09-30

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.

Conditions

Benign Prostatic Hyperplasia (BPH); Overactive Bladder

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard silodosin treatment

Peroral treatment with silodosin at a dose of 8 mg daily

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training (PFMT) with suppressive urgency technique

Intervention Type: 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 with PFMT

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

Group Type: EXPERIMENTAL

Pelvic floor muscle training (PFMT) with suppressive urgency technique

Intervention Type: 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.

Interventions

Pelvic floor muscle training (PFMT) with suppressive urgency technique

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Svihra, Prof,MD,PhD

Role: STUDY_DIRECTOR

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

Magdalena Hagovska, Assoc.pr.PhD

Role: STUDY_CHAIR

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

Locations

Jan Svihra

Martin, , Slovakia

Countries

Slovakia

Other Identifiers

09072020

Identifier Type: -

Identifier Source: org_study_id