Tadalafil Plus Tamsulosin for Male LUTS and ED

Completed

• Conditions: Metabolic Syndrome; Erectile Dysfunction; Prostatic Hyperplasia, Benign; Lower Urinary Tract Symptoms
• Interventions: Drug: Tadalafil 5mg

• Registration Number: NCT04383093
• Lead Sponsor: University of Florence

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.

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combination Therapy	Tadalafil 5mg	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

Primary Outcome Measures

Name	Time	Method
Lower Urinary Tract Symptoms	Changes from Baseline IPSS at 3 months	Through IPSS
Lower Urinary Tract Symptoms - Storage	Changes from Baseline OAB-q at 3 months	Through OAB-q
Erectile Dysfunction	Changes from Baseline IIEF-5 at 3 months	Through IIEF-5
Flowmetry Maximum Flow	Changes from Baseline Maximum Flow at 3 months	Through Maximum Flow (ml/s)
Flowmetry Post Void Residual	Changes from Baseline Post Void Residual at 3 months	Through Post Void Residual (ml)

Secondary Outcome Measures

Name	Time	Method
Combination Therapy Adverse Events	3 months	Drug related adverse events were collected
Combination Therapy Compliance	3 months	Adherence to therapy - did all the patients took the combination therapy daily
Combination Therapy Tolerability	3 months	Measured by the study completion rate by the participants