Benign Prostatic HyperplasiaPhase 4NCT04107896
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
A Phase 4 study testing Silodosin and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally) in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a randomized controlled trial design. Study population would be patients attending Urology OPD of BSMMU Hospital, Dhaka. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Silodosin and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteBangladesh
- Study dates
- 31 Aug 2017to 31 Aug 2018
- Phase
- Phase 4
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)
- International prostate symptoms score (IPSS)≥ 8
- Peak urinary flow rate (Qmax)<15ml/sec for a voided volume of 150 ml or more
- Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram)
- Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm
Who cannot join
- History of prostate cancer/raised PSA>4 ng/ml
- Previous prostate surgery /Periurethral surgery.
- Patient undergone surgery to the bladder neck/Bladder neck contracture.
- Urethral stricture
- History of LUTS not due to benign prostatic hyperplasia (BPH).
- Postvoid residual urine volume of >150ml
Show all 10Show fewer
- Bladder stone
- Active urinary tract infection which might affect micturition
- Large intravesical protrusion > 2 cm
- Known hypersensitivity or history of active substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally) in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a randomized controlled trial design. Study population would be patients attending Urology OPD of BSMMU Hospital, Dhaka. Target sample size will be 136 evaluable patients in each group (assuming dropout rate 20%), suffering from Benign prostatic Hyperplasia .Subjects would be observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated to Silodosin or Tamsulosin and treatment continued for 12 weeks. Interim follow-up visits would be at 1,4 and 12 weeks. USG confirmation of BPH would be required for recruitment. Effectiveness of the drugs would be assessed by International Prostate Symptom score, a quality of life (QoL) assessment done by a 7-point scale. Prostate weight/volume determination by USG, Change in post voidal residual urine (PVR) by USG and Changes in peak urine flow rate by uroflowmetry. Safety would be assessed by following up vital signs, treatment emergent adverse events and routine laboratory tests for drug safety.
Read the detailed description
Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective α1-adrenergic antagonists are now first-line drugs in the medical management of BPH. This Hospital based randomized controlled clinical study designed to evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign prostatic hyperplasia (BPH).Ambulatory patients of age between 50 to 70 years, who were diagnosed as benign prostatic hyperplasia, were divided into two groups after fulfilling selection criteria. After informed consent \& random sampling by lottery, silodosin 8 mg was given to group A (study) \& tamsulosin 0.4 mg was given to group B (control). Total 149 patients were enrolled in this study but 8 patients were lost during follow up. Hence 141 patients completed the study, during the period of June 2017 to August 2018.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Silodosin, Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Also called Rapasin
Cap silodosin
TamsulosinDrug
Also called Uromax
Cap tamsulosin
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Experimental | 8 mg daily by mouth, 12 weeks Receives: Drug: Silodosin |
| Tamsulosin | Active comparator | 0.4 mg daily by mouth, 12 weeks Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IPSS & Quality of life (QoL) score
Effectiveness of silodosin in benign prostatic hyperplasia assessed by symptom relief as assessed by IPSS. The total score was taken as the sum of the seven individual symptom scores. Each individual scored 0-5 (0 = Minimum; 5 = Maximum as worse as can be), yielding a total between 0 and 35. The Storage sub score was taken as the sum of the three individual symptom scores (Range 0-15) \& the Voiding sub score was taken as the sum of the four individual symptom scores (Range 0-20). Quality of life (QoL) score assessment was done on a 7-point scale 0-6 (0= Delighted; 6= Terrible).
Measured: Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week
Secondary outcomes (1)
Changes in peak urine flow rate & post voidal residual urine (PVR)
Changes in peak urine flow rate by uroflowmetry \& post voidal residual urine (PVR) by USG.
Measured: Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start31 Aug 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maidul Islam, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- maidul islam, resident, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107896
- Sponsor's protocol ID
- No BSMMU/2017/9066
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT04107896
- Acronym / sponsor ID
- No BSMMU/2017/9066
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 27 Sep 2019 (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.
In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally) in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a randomized controlled trial design. Study population would be patients attending Urology OPD of BSMMU Hospital, Dhaka. Target sample size will be 136 evaluable patients in each group (assuming dropout rate 20%), suffering from Benign prostatic Hyperplasia .Subjects would be observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated to Silodosin or Tamsulosin and treatment continued for 12 weeks. Interim follow-up visits would be at 1,4 and 12 weeks. USG confirmation of BPH would be required for recruitment. Effectiveness of the drugs would be assessed by International Prostate Symptom score, a quality of life (QoL) assessment done by a 7-point scale. Prostate weight/volume determination by USG, Change in post voidal residual urine (PVR) by USG and Changes in peak urine flow rate by uroflowmetry. Safety would be assessed by following up vital signs, treatment emergent adverse events and routine laboratory tests for drug safety.
Detailed description
Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective α1-adrenergic antagonists are now first-line drugs in the medical management of BPH. This Hospital based randomized controlled clinical study designed to evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign prostatic hyperplasia (BPH).Ambulatory patients of age between 50 to 70 years, who were diagnosed as benign prostatic hyperplasia, were divided into two groups after fulfilling selection criteria. After informed consent \& random sampling by lottery, silodosin 8 mg was given to group A (study) \& tamsulosin 0.4 mg was given to group B (control). Total 149 patients were enrolled in this study but 8 patients were lost during follow up. Hence 141 patients completed the study, during the period of June 2017 to August 2018.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Experimental | Drug: Silodosin8 mg daily by mouth, 12 weeks |
| Tamsulosin | Active comparator | Drug: Tamsulosin0.4 mg daily by mouth, 12 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)
- International prostate symptoms score (IPSS)≥ 8
- Peak urinary flow rate (Qmax)<15ml/sec for a voided volume of 150 ml or more
- Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram)
- Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm
Key exclusion criteria (10 listed)
- History of prostate cancer/raised PSA>4 ng/ml
- Previous prostate surgery /Periurethral surgery.
- Patient undergone surgery to the bladder neck/Bladder neck contracture.
- Urethral stricture
- History of LUTS not due to benign prostatic hyperplasia (BPH).
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 |
|---|---|---|
| SilodosinAlso: RapasinCap silodosin | Drug | Silodosin |
| TamsulosinAlso: UromaxCap tamsulosin | Drug | Tamsulosin |
Primary outcome
Change in IPSS & Quality of life (QoL) score
Time frame: Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week
Effectiveness of silodosin in benign prostatic hyperplasia assessed by symptom relief as assessed by IPSS. The total score was taken as the sum of the seven individual symptom scores. Each individual scored 0-5 (0 = Minimum; 5 = Maximum as worse as can be), yielding a total between 0 and 35. The Storage sub score was taken as the sum of the three individual symptom scores (Range 0-15) \& the Voiding sub score was taken as the sum of the four individual symptom scores (Range 0-20). Quality of life (QoL) score assessment was done on a 7-point scale 0-6 (0= Delighted; 6= Terrible).
1 secondary outcome
Changes in peak urine flow rate & post voidal residual urine (PVR)
Time frame: Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week
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 27 Sep 2019.
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
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.
maidul islam, resident principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 5 inclusion and 10 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 27 Sep 2019. 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 Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 IPSS & Quality of life (QoL) score (time frame: Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week). 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 27 Sep 2019.