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OpenTrials
Completed

NCT Number: NCT04383093

Tadalafil Plus Tamsulosin for Male LUTS and ED

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.

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Key information

Conditions

Prostatic Hyperplasia, Benign Erectile Dysfunction Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tadalafil 5mg

Drug

Combination therapy of daily tadalafil plus tamsulosin

Other names: Tamsulosin 0.4mg

Primary outcomes

  1. Lower Urinary Tract Symptoms

    Time frame: Changes from Baseline IPSS at 3 months

    Through IPSS

  2. Lower Urinary Tract Symptoms - Storage

    Time frame: Changes from Baseline OAB-q at 3 months

    Through OAB-q

  3. Erectile Dysfunction

    Time frame: Changes from Baseline IIEF-5 at 3 months

    Through IIEF-5

  4. Flowmetry Maximum Flow

    Time frame: Changes from Baseline Maximum Flow at 3 months

    Through Maximum Flow (ml/s)

  5. Flowmetry Post Void Residual

    Time frame: Changes from Baseline Post Void Residual at 3 months

    Through Post Void Residual (ml)

Secondary outcomes

  1. Combination Therapy Adverse Events

    Time frame: 3 months

    Drug related adverse events were collected

  2. Combination Therapy Compliance

    Time frame: 3 months

    Adherence to therapy - did all the patients took the combination therapy daily

  3. Combination Therapy Tolerability

    Time frame: 3 months

    Measured by the study completion rate by the participants

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2020
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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