Tadalafil Plus Tamsulosin for Male LUTS and ED

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383093
• Other study ID #: OSS.15.031/2015
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: May 2020
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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 tadala?l or tamsulosin

• prostatic cancer or suspected with prostate-speci?c antigen (PSA) >4 ng/mL

• bladder lithiasis

• previous prostatic surgery

• urinary tract infection

• neurogenic bladder

• ?nasteride or dutasteride use within 3 or 6 months respectively

• clinical history of urethral and/or proven bladder neck obstruction

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tadalafil 5mg
Combination therapy of daily tadalafil plus tamsulosin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Urinary Tract Symptoms	Through IPSS	Changes from Baseline IPSS at 3 months
Primary	Lower Urinary Tract Symptoms - Storage	Through OAB-q	Changes from Baseline OAB-q at 3 months
Primary	Erectile Dysfunction	Through IIEF-5	Changes from Baseline IIEF-5 at 3 months
Primary	Flowmetry Maximum Flow	Through Maximum Flow (ml/s)	Changes from Baseline Maximum Flow at 3 months
Primary	Flowmetry Post Void Residual	Through Post Void Residual (ml)	Changes from Baseline Post Void Residual at 3 months
Secondary	Combination Therapy Adverse Events	Drug related adverse events were collected	3 months
Secondary	Combination Therapy Compliance	Adherence to therapy - did all the patients took the combination therapy daily	3 months
Secondary	Combination Therapy Tolerability	Measured by the study completion rate by the participants	3 months