Prostatic Hyperplasia, Benign, Lower Urinary Tract Symptoms, Erectile Dysfunction, Metabolic Syndrome
Conditions
Keywords
Tadalafil, Tamsulosin, BPH, LUTS, ED, PDE5-I, Alpha-Blockers, METS
Brief 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. 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.
Interventions
DRUGTadalafil 5mg
Combination therapy of daily tadalafil plus tamsulosin
Sponsors
University of Florence
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flowmetry Post Void Residual | Changes from Baseline Post Void Residual at 3 months | Through Post Void Residual (ml) |
| Lower Urinary Tract Symptoms - Storage | Changes from Baseline OAB-q at 3 months | Through OAB-q |
| Erectile Dysfunction | Changes from Baseline IIEF-5 at 3 months | Through IIEF-5 |
| Flowmetry Maximum Flow | Changes from Baseline Maximum Flow at 3 months | Through Maximum Flow (ml/s) |
| Lower Urinary Tract Symptoms | Changes from Baseline IPSS at 3 months | Through IPSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combination Therapy Compliance | 3 months | Adherence to therapy - did all the patients took the combination therapy daily |
| Combination Therapy Tolerability | 3 months | Measured by the study completion rate by the participants |
| Combination Therapy Adverse Events | 3 months | Drug related adverse events were collected |
Outcome results
None listed