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

Primary Purpose

Benign Prostatic Hyperplasia (BPH), Overactive Bladder

Status
Unknown status
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Pelvic floor muscle training (PFMT) with suppressive urgency technique
Sponsored by
Comenius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign prostatic hyperplasia, overactive bladder, silodosin, pelvic floor muscle training

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jan SvihraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard silodosin treatment

Standard silodosin treatment with PFMT

Arm Description

Peroral treatment with silodosin at a dose of 8 mg daily

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Incidence of adverse events .
To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.

Full Information

First Posted
December 16, 2020
Last Updated
March 11, 2022
Sponsor
Comenius University
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1. Study Identification

Unique Protocol Identification Number
NCT04681625
Brief Title
Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder
Acronym
SILODOSING
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Comenius University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH), Overactive Bladder
Keywords
Benign prostatic hyperplasia, overactive bladder, silodosin, pelvic floor muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard silodosin treatment
Arm Type
Active Comparator
Arm Description
Peroral treatment with silodosin at a dose of 8 mg daily
Arm Title
Standard silodosin treatment with PFMT
Arm Type
Experimental
Arm Description
Peroral treatment with silodosin at a dose of 8 mg daily Intervention: Behavioural: Pelvic floor muscle training (PFMT) with suppressive urgency technique
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training (PFMT) with suppressive urgency technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
Description
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.
Time Frame
over 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in lower urinary tract symptoms.
Description
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.
Time Frame
over 12 weeks of treatment
Title
Change in incontinence quality of life .
Description
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.
Time Frame
over 12 weeks of treatment
Title
Change in patient global impression of improvement
Description
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.
Time Frame
over 12 weeks of treatment
Title
Incidence of adverse events .
Description
To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.
Time Frame
over 12 weeks of treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Svihra, Prof,MD,PhD
Phone
+421434133034
Email
jan.svihra@uniba.sk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Svihra, Prof,MD,PhD
Organizational Affiliation
Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak Republic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magdalena Hagovska, Assoc.pr.PhD
Organizational Affiliation
Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
Official's Role
Study Chair
Facility Information:
Facility Name
Jan Svihra
City
Martin
ZIP/Postal Code
03601
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Svihra, prof
Phone
+421905369155
Email
jan.svihra@uniba.sk
First Name & Middle Initial & Last Name & Degree
Jan Svihra, prof
Phone
+421434203444
Email
svihra.jan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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