Clinical trial NCT04383093: Tadalafil Plus Tamsulosin for Male LUTS and ED
Official title: Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia, Benign
Lower Urinary Tract Symptoms
Erectile Dysfunction
Metabolic Syndrome
Keywords: Tadalafil
Tamsulosin
BPH
LUTS
ED
PDE5-I
Alpha-Blockers
METS
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 75
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower Urinary Tract Symptoms
timeFrame: Changes from Baseline IPSS at 3 months
measure: Lower Urinary Tract Symptoms - Storage
timeFrame: Changes from Baseline OAB-q at 3 months
measure: Erectile Dysfunction
timeFrame: Changes from Baseline IIEF-5 at 3 months
measure: Flowmetry Maximum Flow
timeFrame: Changes from Baseline Maximum Flow at 3 months
measure: Flowmetry Post Void Residual
timeFrame: Changes from Baseline Post Void Residual at 3 months
Secondary outcomes:
measure: Combination Therapy Adverse Events
timeFrame: 3 months
measure: Combination Therapy Compliance
timeFrame: 3 months
measure: Combination Therapy Tolerability
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florence
name: Mauro Gacci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Arcangelo Sebastianelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Sergio Serni, MD
role: PRINCIPAL_INVESTIGATOR
References: