Overactive bladder (OAB) in men with benign prostatic hyperplasia (BPH) has a negative impact on quality of life (QoL).  Currently, there are few studies on the effects of combined treatment of pelvic floor muscle training and silodosin in men with BPH and OAB. The aim of the study was to evaluate the effect of combining pelvic floor muscle training (PFMT) with the urgency-suppression technique and silodosin in comparison with silodosin alone in men with the Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB) after 12 weeks of treatment.

The SILODOSING study was conducted from January 2021 to September 2022. It was a randomized intervention, parallel, multicentre study at urological outpatient clinics for period of 12 weeks. Men were assigned in a 1:1 ratio to the experimental and control groups. Computer-generated sequences were used for the allocation process by a researcher who will not participate in the study. The computer generates an even and odd patient number. Odd-numbered patients (control group) had silodosin monotherapy, while even-numbered patients (experimental group) had combination treatment with silodosin and pelvic floor muscle exercises at the same time. Both groups received oral treatment with silodosin at a daily dose of 8 mg once daily for a period of 12 weeks. The experimental group received also pelvic floor muscle training (PFMT) 5 times a week for 30 min a day, for a period of 12 weeks. Behavioural intervention was done as a pelvic floor muscle training with an urgency-suppression techniques. Inclusion criteria: men willing to provide written informed consent; men over 50 years with lower urinary tract symptoms (LUTS), overactive bladder, and a benign prostatic hyperplasia; persistence of overactive bladder despite four weeks of silodosin treatment; symptoms of overactive bladder (urinary frequency and urgency with or without urinary urgency incontinence) for ≥ 3 months prior to Visit 1; men willing and able to complete the three-day voiding diary and questionnaires; International Prostate Symptom Score (IPSS) score ≥8; eight or more voiding per day over the three-day diary; an average of 2 episodes of urgency per day (grade 3 or 4) over the three-day diary period. Exclusion criteria: post-void residual volume (PVR) >200 mL; evidence of urinary tract infection and hematuria; use of anti-muscarinics or beta-3-mimetics within 4 weeks prior to Visit 1 and during the study; oncological diseases of the lower urinary tract and prostate; neurogenic lower urinary tract dysfunction; urethral strictures and bladder neck stenosis; urolithiasis; diabetes mellitus; previous surgery of lower urinary tract; stress urinary incontinence; intermittent catheterization; 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 enrolment; cognitive deficits and dementia; man has participated in an interventional trial within 30 days prior to enrolment; total daily urine production over 2500 mL according to voiding diary. The primary outcome was the change in the number of voiding’s and intensity of urgencies (PPIUS) over 24 hours using a voiding diary. The secondary outcomes were the changes in the IPSS, a change in incontinence quality of life, a change in patients’ global impression of improvement, and an incidence of adverse events. The IPSS is a 7-point scale for assessing the lower urinary tract symptoms (0 - no symptoms, 35 – severe symptoms). One question is focused on quality of life. The Overactive Bladder Questionnaire (OAB-q) contains 6 questions with symptom scores (0 – no symptoms, 100 - the highest symptoms) and 13 questions that evaluate quality of life (100 – the best quality of life, 0 – the worst quality of life). The Patient Global Impression of Improvement (PGI-I) score evaluated the status of LUTS at the end of the study compared to the condition before each patient started treatment. It is a seven-point scale instrument of patient reported outcome measures (1 – very much better, 2 – much better, 3 – a little better, 4 – no change, 5 – a little worse, 6 – much worse, 7 – very much worse). The data were presented as mean values and standard deviations (SD), p values were obtained using a t test with ANOVA. The significance level was set at p<0.05.

A total of 172 men were included in the study of whom 142 completed it. The final group consisted of 70 men in the control group with a mean age of 68.9±9.7 years and 72 men in the experimental group with a mean age of 66.2±7.9 years. After 12 weeks of treatment, significant differences were noted in favour of the experimental group (p <0.001) the majority of monitored parameter with small - medium effect size (ES). There were no significant differences between both group before the intervention in the numbers of voiding’s per 24 hours (10.6±1.9 in the experimental group vs 10.5 ± 1.8 in the control group; p=0.86) but statistically significant changes following treatment (8.4±2.2 vs 9.4±1.6; p=0.003). Baseline night-time frequency (nocturia) was not statistically significant different (2.4±0.9 in the experimental group vs 2.3±0.9 in the control group; p=0.58), but final frequency was (1.4±0.9 in the experimental group vs 1.8±0.8 in the control group; p=0.01). Baseline mean voided volume per 24 hours (ml) was not statistically significant different (165.7±42.7 in the experimental group vs 165.3±38.0 in the control group; p=0.95), nor was final mean voided volume (196.7±48.3 in the experimental group vs 183.9±48.0 in the control group; p=0.11). There were no significant differences between the groups in the voided volume during 24 hours before and after the intervention. After 12 weeks of treatment, significant differences were noted in favour of the experimental group (p <0.001) in the OAB-q symptom score (26.6±14.3 vs 33.2 ± 12.1), the OAB-q quality of life (74.0±15.1 vs 68.8±13.9), the PPIUS (1.2±0.6 vs 2.4±0.7), the IPSS (12.7±4.8 vs 16.2±4.3) and the PGI (2.2±0.7 vs 3.6±0.9). The following adverse events were found dizziness, tachycardia, falling off, nasal congestion, diarrhoea, nausea, dryness, skin rash, libido, ejaculatory disorders, erectile dysfunction. Ejaculatory disorders were the most common adverse events (17.6%) and nasal congestion (12.7 %) as well. There were no statistically significant differences in prevalence of the adverse events between groups.

The Patient Global Impression of Improvement score confirmed that patients with combining pelvic floor muscle training with the urgency-suppression technique and silodosin had statistically significant improvement in most of the variables studied. This treatment group achieved the best PGI-I scores, as 48.6% of men with silodosin and 94.4% of men with combination treatment improved subjectively.

The addition of pelvic floor muscle training with the urgency-suppression technique to silodosin treatment significantly improves overactive bladder syndrome in men with benign prostatic hyperplasia compared with silodosin alone.

Continence 7S1 (2023) 100942
DOI: 10.1016/j.cont.2023.100942