Tadalafil Plus Tamsulosin for Male LUTS and ED

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction

Conditions
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Prostatic Hyperplasia, Benign, Lower Urinary Tract Symptoms, Erectile Dysfunction, Metabolic Syndrome

Intervention / Treatment
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* Drug: Tadalafil 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to severe ED (International Index of Erectile Function-Erectile Function-5 <22) moderate to severe LUTS (International Prostate Symptom Score >7) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combination Therapy<br>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 | Drug: Tadalafil 5mg<br>* Combination therapy of daily tadalafil plus tamsulosin<br>* Other names: Tamsulosin 0.4mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Urinary Tract Symptoms | Through IPSS | Changes from Baseline IPSS at 3 months | 
| Lower Urinary Tract Symptoms - Storage | Through OAB-q | Changes from Baseline OAB-q at 3 months | 
| Erectile Dysfunction | Through IIEF-5 | Changes from Baseline IIEF-5 at 3 months | 
| Flowmetry Maximum Flow | Through Maximum Flow (ml/s) | Changes from Baseline Maximum Flow at 3 months | 
| Flowmetry Post Void Residual | Through Post Void Residual (ml) | Changes from Baseline Post Void Residual at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination Therapy Adverse Events | Drug related adverse events were collected | 3 months | 
| Combination Therapy Compliance | Adherence to therapy - did all the patients took the combination therapy daily | 3 months | 
| Combination Therapy Tolerability | Measured by the study completion rate by the participants | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tadalafil, Tamsulosin, BPH, LUTS, ED, PDE5-I, Alpha-Blockers, METS