The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy

February 19, 2023 updated by: Ivo Juginovic, University Hospital of Split

A Study Evaluating the Therapeutic Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy

The purpose of this study is to evaluate the therapeutic efficacy of tamsulosin and tadalafil compared to placebo in the treatment and prevention of urinary disorders after transperineal prostate biopsy

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

After being informed about the clinical study and all the risks, all patients will be given a written informed consent. They will be randomised in three groups: A (tadalafil),B (tamsulosin) and C (placebo) and the drug or placebo will be administrated seven days before and seven days after transperineal prostate biopsy. Thirty minutes before the biopsy, all patients will receive a prophylactic antibiotic (ceftriaxone 2g intravenously) and an analgetic ( naklofen 75mg intramuscular injection). Before the biopsy patients will do an uroflowmetry to determine the Qmax and ultrasound(US) of the urinary tract to determine residual urine. After the biopsy is performed the patient fills out the international prostate symptom score (IPSS/QoL), visual analog scale (VAS) for pain, International Index of Erectile Function (IIEF-5) and 36-Item Short Form Survey (SF-36) questionnaires. Seven days after the biopsy the patient discontinues with the therapy and makes a visit for routine control of uroflowmetry, US of the urinary tract and he previously mentioned questionnaires are filled out. After 30 days of the biopsy the patient makes a visit for regular control of the pathohistological findings, uroflowmetry and ultrasound of the urinary tract, along with filling out the questionnaires again.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Splitsko-dalmatinska
      • Split, Splitsko-dalmatinska, Croatia, 21000
        • University hospital of Splity

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Every patient that is a candidate for first time prostate biopsy

Exclusion Criteria:

  • previous complaints of the lower urinary tract; benign prostatic hyperplasia(BPH), overactive bladder (OAB), etc.
  • previous urinary retention and catheterization
  • previous prostate biopsies
  • patients who were treated surgically or medically for BPH
  • systemic diseases including uncontrolled diabetes
  • neurological diseases
  • hemorrhagic diathesis
  • patients on anticoagulants therapy
  • patients with urinary infections

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Administration of placebo ( Vitamin C [ascorbic acid] 500mg tablet) once daily seven days before and seven days after prostate biopsy
Other Names:
  • Vitamin C (ascorbic acid) 500mg tablets
Active Comparator: Tamsulosin
Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule
Administration of Tamsulosin 0.4mg once daily seven days before and seven days after prostate biopsy
Active Comparator: Tadalafil
Drug: Tadalafil 5mg
Administration of Tadalafil 5mg once daily seven days before and seven days after prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual analog scale for pain (VAS)
Time Frame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy
Visual analog scale is a simple scale that rates pain form zero to ten, where zero is rated as no pain and ten is rated as unbearable pain. The patient fills it by putting an X on the lane, where no pain, mild and moderate pain is on the left side of the line and severe, very severe and worst pain possible is on the right side of the line.
Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy
Change in International prostate symptom score ( IPSS/QoL)
Time Frame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy

The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.

It is a validated, reproducible scoring system to assess disease severity and response to therapy.

The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

There is also a separate question regarding quality of life.
Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in The short form health survey - SF-36
Time Frame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy
SF -36 measure eight dimensions of quality of life: physical functioning (10 items), role limitation due to physical problems (4 items), bodily pain (2 items), social functioning (2 items), mental health (5 items), role limitation due to emotional problems (3 items), vitality (4 items) and general health perception (5 items). Each dimension has a possible score of 0 (poor health) to 100 (excellent health)
Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy
Change in The International Index of Erectile Function (IIEF-5) Questionnaire
Time Frame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy

IIEF-5 is a validated questionnaire for erectile function. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.

Based on equal misclassification rates of erectile disfunction (ED) and no ED, a cutoff score of 21 (range of scores, 5-25) discriminated best. ED was classified into five severity levels, ranging from none (22-25) through severe (5-7). Substantial agreement existed between the predicted and 'true' ED classes. These data suggest that the IIEF-5 possesses favorable properties for detecting the presence and severity of ED.
Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy

Collaborators and Investigators

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

Sponsor

University Hospital of Split

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 11, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHSplit

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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