Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic HyperplasiaNCT04577040
Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
An observational study of Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia, run by Menoufia University.
Trial summary
To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia Read more about this study
- Who is it for?
- Ages 45 to 99 years, men only
- Conditions the study is for
- Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
- What is being tested?
- Tadalafil 5mg
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2022
- Phase
- Observational
- 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 45 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Middle and old aged males
Who may be able to join
- Patients to be included in the study will be either:
- diagnosis of BPH based on abdominal ultrasound or digital rectal examination.
- Moderate IPSS Score between 8 : 19.
- severe IPSS Score between 20 : 35.
- post void volume > 100 c.
- prostate size 50 to 80 gm.
- 2 or more weeks of freedom or washout from any medications known to influence LUTS before enrollment.
- mental and physical capacity to understand and fill out the study questionnaires.
Who cannot join
- contraindications to Sildosin or Tadalafil.
- diagnosis of prostate cancer.
- possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention.
- clinically significant cardiovascular, hepatic, or renal disorders.
- cataract surgery planned during the study period.
About this study
To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia
Read the detailed description
Introduction Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men, and the incidence rate of LUTS associated with BPH (LUTS/BPH) increases with age.
LUTS can be broadly grouped into: (i) storage symptoms, such as frequency, urgency, and nocturia (ii) voiding symptoms, such as intermittency, weak stream and straining, and (iii) post-micturition symptoms, such as a feeling of incomplete emptying and post micturition dribble.
For optimal management of LUTS/BPH, medications should be chosen based on age, disease progression, need for long-term management, and other clinical parameters.
Alpha 1 adreno-receptors antagonists (alpha 1 blockers) are proposed as first-line drug therapy for LUTS/BPH as these agents reduce the adrenergic tone of the smooth muscle within the prostate and bladder neck, thereby relieving the bladder outlet obstruction.
Tadalafil (phosphodiesterase type 5 [PDE-5] inhibitor) was approved for treating LUTS/BPH. The inhibition of PDE-5leads to accumulation of cyclic guanosine monophosphate in the smooth muscles of the prostate and urethra which causes their relaxation resulting in alleviation of the symptoms of LUTS/BPH.
- Being tested
- Tadalafil 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called Sildosin
Drugs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Tadalafil in moderate puts Receives: Drug: Tadalafil 5mg | |
| 2 | Tadalafil in severe puts Receives: Drug: Tadalafil 5mg | |
| 3 | Tadalafil with sildosin in moderate luts Receives: Drug: Tadalafil 5mg | |
| 4 | Tadalafil with sildosin in severe luts Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom relief
Decreased AUA score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yaseen, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577040
- Sponsor's protocol ID
- 10-2020urol
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04577040
- Acronym / sponsor ID
- 10-2020urol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 6 Oct 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.
To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia
Detailed description
Introduction Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men, and the incidence rate of LUTS associated with BPH (LUTS/BPH) increases with age.
LUTS can be broadly grouped into: (i) storage symptoms, such as frequency, urgency, and nocturia (ii) voiding symptoms, such as intermittency, weak stream and straining, and (iii) post-micturition symptoms, such as a feeling of incomplete emptying and post micturition dribble.
For optimal management of LUTS/BPH, medications should be chosen based on age, disease progression, need for long-term management, and other clinical parameters.
Alpha 1 adreno-receptors antagonists (alpha 1 blockers) are proposed as first-line drug therapy for LUTS/BPH as these agents reduce the adrenergic tone of the smooth muscle within the prostate and bladder neck, thereby relieving the bladder outlet obstruction.
Tadalafil (phosphodiesterase type 5 [PDE-5] inhibitor) was approved for treating LUTS/BPH. The inhibition of PDE-5leads to accumulation of cyclic guanosine monophosphate in the smooth muscles of the prostate and urethra which causes their relaxation resulting in alleviation of the symptoms of LUTS/BPH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Tadalafil 5mgTadalafil in moderate puts |
| 2 | – | Drug: Tadalafil 5mgTadalafil in severe puts |
| 3 | – | Drug: Tadalafil 5mgTadalafil with sildosin in moderate luts |
| 4 | – | Drug: Tadalafil 5mgTadalafil with sildosin in severe luts |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Middle and old aged males
Key inclusion criteria (8 listed)
- Patients to be included in the study will be either:
Key exclusion criteria (5 listed)
- contraindications to Sildosin or Tadalafil.
- diagnosis of prostate cancer.
- possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention.
- clinically significant cardiovascular, hepatic, or renal disorders.
- cataract surgery planned during the study period.
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 |
|---|---|---|
| Tadalafil 5mgAlso: SildosinDrugs | Drug | 1, 2, 3, 4 |
Primary outcome
Symptom relief
Time frame: 2 weeks
Decreased AUA score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia, run by Menoufia University.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Symptom relief (time frame: 2 weeks). 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 6 Oct 2020.