Tadalafil Plus Tamsulosin for Male LUTS and ED

University of Florence (UNIFI)

Status: Completed

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

Treatments: Drug: Tadalafil 5mg

Study type: Observational

Funder types: Other

Identifiers

NCT04383093

OSS.15.031/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Combination Therapy

Description:

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

Treatment:

Drug: Tadalafil 5mg