Benign Prostatic Hyperplasia (BPH)SILODOSINGNCT04681625
Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder
A study testing Pelvic floor muscle training (PFMT) with suppressive urgency technique in people with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder, run by Comenius University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Overactive Bladder
- What is being tested?
- Pelvic floor muscle training (PFMT) with suppressive urgency technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSlovakia
- Study dates
- 11 Jan 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.
Read the 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.
- Being tested
- Pelvic floor muscle training (PFMT) with suppressive urgency technique
- Keywords
- Benign prostatic hyperplasia, overactive bladder, silodosin, pelvic floor muscle training
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training (PFMT) with suppressive urgency techniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard silodosin treatment | Active comparator | Peroral treatment with silodosin at a dose of 8 mg daily Receives: Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique |
| Standard silodosin treatment with PFMT | Experimental | Peroral treatment with silodosin at a dose of 8 mg daily Intervention: Behavioural: Pelvic floor muscle training (PFMT) with suppressive urgency technique Receives: Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 12 weeks of treatment
Secondary outcomes (4)
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.
Measured: over 12 weeks of treatment
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.
Measured: over 12 weeks of treatment
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.
Measured: over 12 weeks of treatment
Incidence of adverse events .
To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.
Measured: over 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start11 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Svihra, Prof,MD,PhD, Study director, Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak RepublicMagdalena Hagovska, Assoc.pr.PhD, Study chair, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681625
- Sponsor's protocol ID
- 09072020
- Acronym
- SILODOSING
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04681625
- Acronym / sponsor ID
- SILODOSING / 09072020
- Keywords
- Benign prostatic hyperplasia, overactive bladder, silodosin, pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Standard silodosin treatment | Active comparator | Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency techniquePeroral treatment with silodosin at a dose of 8 mg daily |
| Standard silodosin treatment with PFMT | Experimental | Behavioral: Pelvic floor muscle training (PFMT) with suppressive urgency techniquePeroral treatment with silodosin at a dose of 8 mg daily Intervention: Behavioural: Pelvic floor muscle training (PFMT) with suppressive urgency technique |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training (PFMT) with suppressive urgency techniquePelvic 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. | Behavioural | Standard silodosin treatment, Standard silodosin treatment with PFMT |
Primary outcome
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
Time frame: 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.
4 secondary outcomes
Change in lower urinary tract symptoms.
Time frame: over 12 weeks of treatment
Change in incontinence quality of life .
Time frame: over 12 weeks of treatment
Change in patient global impression of improvement
Time frame: over 12 weeks of treatment
Incidence of adverse events .
Time frame: over 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Svihra, Prof,MD,PhD study director
Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak Republic
Magdalena Hagovska, Assoc.pr.PhD study chair
Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training (PFMT) with suppressive urgency technique in people with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary. (time frame: over 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.