An observational study in Prostatic Hyperplasia, Benign, Lower Urinary Tract Symptoms and Erectile Dysfunction, sponsored by University of Florence. Completed. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-11.
Sponsored by University of Florence · Observational
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.
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 75 is below the median of 130 across 115 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
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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.
Exclusion Criteria:
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
Combination therapy of daily tadalafil plus tamsulosin
Also known as: Tamsulosin 0.4mg
Lower Urinary Tract Symptoms
Through IPSS
Time frame: Changes from Baseline IPSS at 3 months
Lower Urinary Tract Symptoms - Storage
Through OAB-q
Time frame: Changes from Baseline OAB-q at 3 months
Erectile Dysfunction
Through IIEF-5
Time frame: Changes from Baseline IIEF-5 at 3 months
Flowmetry Maximum Flow
Through Maximum Flow (ml/s)
Time frame: Changes from Baseline Maximum Flow at 3 months
Flowmetry Post Void Residual
Through Post Void Residual (ml)
Time frame: Changes from Baseline Post Void Residual at 3 months
Combination Therapy Adverse Events
Drug related adverse events were collected
Time frame: 3 months
Combination Therapy Compliance
Adherence to therapy - did all the patients took the combination therapy daily
Time frame: 3 months
Combination Therapy Tolerability
Measured by the study completion rate by the participants
Time frame: 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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University of Florence