Tadalafil Plus Tamsulosin for Male LUTS and ED

NCT04383093 | Completed

• 1 other identifier: OSS.15.031/2015
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Tadalafil; Tamsulosin; BPH; LUTS; ED; PDE5-I; Alpha-Blockers; METS

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Combination Therapy Adverse Events

  3 months

• Combination Therapy Compliance

  3 months

• Combination Therapy Tolerability

  3 months

Study Arms (1)

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

Interventions

Tadalafil 5mg DRUG

Combination therapy of daily tadalafil plus tamsulosin

Also known as: Tamsulosin 0.4mg

Combination Therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• mild to severe ED (International Index of Erectile Function-Erectile Function-5 \<22)
• moderate to severe LUTS (International Prostate Symptom Score \>7)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction; Metabolic Syndrome

Interventions

Tadalafil; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Mauro Gacci, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

• Arcangelo Sebastianelli, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

• Sergio Serni, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 11, 2020
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share