Benign Prostatic Hyperplasia (BPH), Overactive Bladder
Conditions
Keywords
Benign prostatic hyperplasia, overactive bladder, silodosin, pelvic floor muscle training
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.
Interventions
BEHAVIORALPelvic 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.
Sponsors
Comenius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary. | over 12 weeks of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in lower urinary tract symptoms. | over 12 weeks of treatment | 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 . | over 12 weeks of treatment | 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 | over 12 weeks of treatment | 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 . | over 12 weeks of treatment | To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. |
Countries
Slovakia
Outcome results
None listed