Tadalafil Plus Tamsulosin for Male LUTS and ED

May 7, 2020 updated by: Simone Morselli, University of Florence

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

75

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Combination Therapy

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
Drug: Tadalafil 5mg
Combination therapy of daily tadalafil plus tamsulosin
Other Names:
  • Tamsulosin 0.4mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Investigators

  • Principal Investigator: Mauro Gacci, MD, University of Florence
  • Principal Investigator: Arcangelo Sebastianelli, MD, University of Florence
  • Principal Investigator: Sergio Serni, MD, University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSS.15.031/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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