Tadalafil Plus Tamsulosin for Male LUTS and ED

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Metabolic Syndrome; Erectile Dysfunction; Prostatic Hyperplasia, Benign
• Intervention / Treatment: Drug: Tadalafil 5mg

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 Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Drug: Tadalafil 5mg; Combination therapy of daily tadalafil plus tamsulosin; Other Names: Tamsulosin 0.4mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florence
• Investigators: Principal Investigator: Mauro Gacci, MD, University of Florence; Principal Investigator: Arcangelo Sebastianelli, MD, University of Florence; Principal Investigator: Sergio Serni, MD, University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: ED; LUTS; Tadalafil; BPH; Tamsulosin; PDE5-I; Alpha-Blockers; METS
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Urological Manifestations; Prostatic Diseases; Insulin Resistance; Hyperinsulinism; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Metabolic Syndrome; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tadalafil; Tamsulosin
• Other Study ID Numbers: OSS.15.031/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No