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

NCT05537272 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: UHSplit
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Urinary Tract Symptoms; Voiding Disorders; Pain; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Change in Visual analog scale for pain (VAS)

  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)

  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 Outcomes (2)

• Change in The short form health survey - SF-36

  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 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy

Study Arms (3)

Tadalafil

ACTIVE COMPARATOR

Drug: Tadalafil 5mg

Tamsulosin

ACTIVE COMPARATOR

Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tadalafil 5mg DRUG

Administration of Tadalafil 5mg once daily seven days before and seven days after prostate biopsy

Tadalafil

Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule DRUG

Administration of Tamsulosin 0.4mg once daily seven days before and seven days after prostate biopsy

Tamsulosin

Placebo OTHER

Administration of placebo ( Vitamin C \[ascorbic acid\] 500mg tablet) once daily seven days before and seven days after prostate biopsy

Also known as: Vitamin C (ascorbic acid) 500mg tablets

Placebo

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University hospital of Splity

Split, Split-Dalmatia County, 21000, Croatia

Location

Related Publications (8)

• Sefik E, Eker A, Gunlusoy B, Celik S, Bozkurt IH, Basmaci I, Polat S, Degirmenci T, Ceylan Y. The effect of alpha blocker treatment prior to prostate biopsy on voiding functions, pain scores and health-related quality-of-life outcomes: A prospective randomized trial. Prog Urol. 2020 Mar;30(4):198-204. doi: 10.1016/j.purol.2019.12.006. Epub 2020 Jan 23.

  PMID: 31983605 RESULT

• Efesoy O, Saylam B, Tek M, Bozlu M, Akbay E. Is there any priority between the alpha blockers on voiding functions after transrectal ultrasound guided prostate biopsy? Turk J Urol. 2021 Mar;47(2):137-143. doi: 10.5152/tud.2021.20509. Epub 2021 Mar 1.

  PMID: 33819444 RESULT

• Chung SJ, Jung SI, Ryu JW, Hwang EC, Kwon DD, Park K, Kim JW. The preventive effect of tamsulosin on voiding dysfunction after prostate biopsy: a prospective, open-label, observational study. Int Urol Nephrol. 2015 May;47(5):711-5. doi: 10.1007/s11255-015-0955-7. Epub 2015 Mar 27.

  PMID: 25812823 RESULT

• Porst H, Oelke M, Goldfischer ER, Cox D, Watts S, Dey D, Viktrup L. Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Urology. 2013 Sep;82(3):667-73. doi: 10.1016/j.urology.2013.05.005. Epub 2013 Jul 19.

  PMID: 23876588 RESULT

• Dong Y, Hao L, Shi Z, Wang G, Zhang Z, Han C. Efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a meta-analysis. Urol Int. 2013;91(1):10-8. doi: 10.1159/000351405. Epub 2013 Jun 25.

  PMID: 23816815 RESULT

• Zisman A, Leibovici D, Kleinmann J, Cooper A, Siegel Y, Lindner A. The impact of prostate biopsy on patient well-being: a prospective study of voiding impairment. J Urol. 2001 Dec;166(6):2242-6.

  PMID: 11696744 RESULT

• Bozlu M, Ulusoy E, Doruk E, Cayan S, Canpolat B, Schellhammer PF, Akbay E. Voiding impairment after prostate biopsy: does tamsulosin treatment before biopsy decrease this morbidity? Urology. 2003 Dec;62(6):1050-3. doi: 10.1016/j.urology.2003.07.006.

  PMID: 14665353 RESULT

• Murray KS, Bailey J, Zuk K, Lopez-Corona E, Thrasher JB. A prospective study of erectile function after transrectal ultrasonography-guided prostate biopsy. BJU Int. 2015 Aug;116(2):190-5. doi: 10.1111/bju.13002. Epub 2015 Mar 23.

  PMID: 25430505 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Pain

Interventions

Tadalafil; Ascorbic Acid

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Ivo Juginović

  University Hospital Split,Department of Urology

  PRINCIPAL INVESTIGATOR

• Marijan Šitum

  University Hospital Split,Department of Urology

  STUDY DIRECTOR

• Sandro Glumac

  University Hospital Split, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

• Mario Duvnjak

  University Hospital Split,Department of Urology

  STUDY CHAIR

• Marin Jelavić

  University Hospital Split,Department of Urology

  STUDY CHAIR

• Ruben Kovač

  University Hospital Split, Department of Anesthesiology and Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine (MD), Principal Investigator

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)