Prostatic Hyperplasia, BenignNCT04383093
Tadalafil Plus Tamsulosin for Male LUTS and ED
An observational study of Prostatic Hyperplasia, Benign and Lower Urinary Tract Symptoms, run by University of Florence.
Trial summary
Metabolic Syndrome (MetS) is a complex epidemic disorder with an impact on both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Combination therapy of daily tadalafil and tamsulosin may provide relief to both diseases. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign, Lower Urinary Tract Symptoms, Erectile Dysfunction
- What is being tested?
- Tadalafil 5mg
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2018
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction (BPO) were screened for the trial. Inclusion criteria were age >40 to 80 years, mild to severe ED (International Index of Erectile Function-Erectile Function-5 <22), moderate to severe LUTS (International Prostate Symptom Score >7), while exclusion criteria were hypersensitivity to tadalafil or tamsulosin, prostatic cancer or suspected with prostate-specific antigen (PSA) >4 ng/mL, bladder lithiasis, previous prostatic surgery, urinary tract infection, neurogenic bladder, finasteride or dutasteride use within 3 or 6 months, respectively, clinical history of urethral and/or proven bladder neck obstruction.
Who may be able to join
- mild to severe ED (International Index of Erectile Function-Erectile Function-5 <22)
- moderate to severe LUTS (International Prostate Symptom Score >7)
Who cannot join
- hypersensitivity to tadalafil or tamsulosin
- prostatic cancer or suspected with prostate-specific antigen (PSA) >4 ng/mL
- bladder lithiasis
- previous prostatic surgery
- urinary tract infection
- neurogenic bladder
- finasteride or dutasteride use within 3 or 6 months respectively
- clinical history of urethral and/or proven bladder neck obstruction
About this study
Official title: Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction
Metabolic Syndrome (MetS) is a complex epidemic disorder with an impact on both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Combination therapy of daily tadalafil and tamsulosin may provide relief to both diseases.
Aim of the present study is to assess the impact of combination therapy of Tadalafil 5mg plus Tamsulosin 0.4mg on LUTS and ED, according to presence vs. absence of Mets.
Read the detailed description
75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction were enrolled. Patients were divided into two groups according to MetS presence or absence. All subjects were then treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5 and comparison were made in and between groups.
- Conditions
- Prostatic Hyperplasia, Benign, Lower Urinary Tract Symptoms, Erectile Dysfunction, Metabolic Syndrome
- Being tested
- Tadalafil 5mg
- Keywords
- Tadalafil, Tamsulosin, BPH, LUTS, ED, PDE5-I, Alpha-Blockers, METS
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Erectile Dysfunction, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called Tamsulosin 0.4mg
Combination therapy of daily tadalafil plus tamsulosin
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Patients initial assessment included age, waist circumference, blood pressure, clinical laboratory parameters, digital rectal examination. LUTS were evaluated with total IPSS, focusing also on storage, voiding IPSS sub-scores, and IPSS QoL, and Overactive Bladder questionnaire (OAB-q), while ED with IIEF-515. Each patient underwent uroflowmetry and postvoid residual volume (PVR) was measured with abdominal ultrasound immediately after voiding. All patients reporting any intake of therapies for LUTS or ED underwent a 4 weeks treatment-free washout period.
All subjects were treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. The medications were self-administered every day at the same time, before the night rest, without any limitations or variations of sexual activity timing or food intake. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5 Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Urinary Tract Symptoms
Through IPSS
Measured: Changes from Baseline IPSS at 3 months
Lower Urinary Tract Symptoms - Storage
Through OAB-q
Measured: Changes from Baseline OAB-q at 3 months
Erectile Dysfunction
Through IIEF-5
Measured: Changes from Baseline IIEF-5 at 3 months
Flowmetry Maximum Flow
Through Maximum Flow (ml/s)
Measured: Changes from Baseline Maximum Flow at 3 months
Flowmetry Post Void Residual
Through Post Void Residual (ml)
Measured: Changes from Baseline Post Void Residual at 3 months
Secondary outcomes (3)
Combination Therapy Adverse Events
Drug related adverse events were collected
Measured: 3 months
Combination Therapy Compliance
Adherence to therapy - did all the patients took the combination therapy daily
Measured: 3 months
Combination Therapy Tolerability
Measured by the study completion rate by the participants
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Hyperplasia, BenignStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Morselli, University of Florence
- Investigators
- Mauro Gacci, MD, Principal investigator, University of FlorenceArcangelo Sebastianelli, MD, Principal investigator, University of FlorenceSergio Serni, MD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383093
- Sponsor's protocol ID
- OSS.15.031/2015
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 11 May 2020
- Results posted
- 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 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04383093
- Acronym / sponsor ID
- OSS.15.031/2015
- Conditions
- Prostatic Hyperplasia, Benign, Lower Urinary Tract Symptoms, Erectile Dysfunction, Metabolic Syndrome
- Keywords
- Tadalafil, Tamsulosin, BPH, LUTS, ED, PDE5-I, Alpha-Blockers, METS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 11 May 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.
Metabolic Syndrome (MetS) is a complex epidemic disorder with an impact on both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Combination therapy of daily tadalafil and tamsulosin may provide relief to both diseases.
Aim of the present study is to assess the impact of combination therapy of Tadalafil 5mg plus Tamsulosin 0.4mg on LUTS and ED, according to presence vs. absence of Mets.
Detailed description
75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction were enrolled. Patients were divided into two groups according to MetS presence or absence. All subjects were then treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5 and comparison were made in and between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | – | Drug: Tadalafil 5mgPatients initial assessment included age, waist circumference, blood pressure, clinical laboratory parameters, digital rectal examination. LUTS were evaluated with total IPSS, focusing also on storage, voiding IPSS sub-scores, and IPSS QoL, and Overactive Bladder questionnaire (OAB-q), while ED with IIEF-515. Each patient underwent uroflowmetry and postvoid residual volume (PVR) was measured with abdominal ultrasound immediately after voiding. All patients reporting any intake of therapies for LUTS or ED underwent a 4 weeks treatment-free washout period. All subjects were treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. The medications were self-administered every day at the same time, before the night rest, without any limitations or variations of sexual activity timing or food intake. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction (BPO) were screened for the trial. Inclusion criteria were age >40 to 80 years, mild to severe ED (International Index of Erectile Function-Erectile Function-5 <22), moderate to severe LUTS (International Prostate Symptom Score >7), while exclusion criteria were hypersensitivity to tadalafil or tamsulosin, prostatic cancer or suspected with prostate-specific antigen (PSA) >4 ng/mL, bladder lithiasis, previous prostatic surgery, urinary tract infection, neurogenic bladder, finasteride or dutasteride use within 3 or 6 months, respectively, clinical history of urethral and/or proven bladder neck obstruction.
Key inclusion criteria (2 listed)
- mild to severe ED (International Index of Erectile Function-Erectile Function-5 <22)
- moderate to severe LUTS (International Prostate Symptom Score >7)
Key exclusion criteria (8 listed)
- hypersensitivity to tadalafil or tamsulosin
- prostatic cancer or suspected with prostate-specific antigen (PSA) >4 ng/mL
- bladder lithiasis
- previous prostatic surgery
- urinary tract infection
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: Tamsulosin 0.4mgCombination therapy of daily tadalafil plus tamsulosin | Drug | Combination Therapy |
Primary outcome
Lower Urinary Tract Symptoms
Time frame: Changes from Baseline IPSS at 3 months
Through IPSS
Lower Urinary Tract Symptoms - Storage
Time frame: Changes from Baseline OAB-q at 3 months
Through OAB-q
Erectile Dysfunction
Time frame: Changes from Baseline IIEF-5 at 3 months
Through IIEF-5
Flowmetry Maximum Flow
Time frame: Changes from Baseline Maximum Flow at 3 months
Through Maximum Flow (ml/s)
Flowmetry Post Void Residual
Time frame: Changes from Baseline Post Void Residual at 3 months
Through Post Void Residual (ml)
3 secondary outcomes
Combination Therapy Adverse Events
Time frame: 3 months
Combination Therapy Compliance
Time frame: 3 months
Combination Therapy Tolerability
Time frame: 3 months
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 11 May 2020.
- 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.
Mauro Gacci, MD principal investigator
University of Florence
Arcangelo Sebastianelli, MD principal investigator
University of Florence
Sergio Serni, MD principal investigator
University of Florence
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, Benign and Lower Urinary Tract Symptoms, run by University of Florence.
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 2 inclusion and 8 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 11 May 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?
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?
Lower Urinary Tract Symptoms (time frame: Changes from Baseline IPSS at 3 months). The study lists 5 primary outcomes in all. 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 11 May 2020.