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

Overactive Bladder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681625
• Other study ID #: 09072020
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2023
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Slovakia	Jan Svihra	Martin

Sponsors (1)

Lead Sponsor	Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	over 12 weeks of treatment
Secondary	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.	over 12 weeks of treatment
Secondary	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.	over 12 weeks of treatment
Secondary	Incidence of adverse events .	To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.	over 12 weeks of treatment