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

NCT ID: NCT05537272

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-09-01

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Tadalafil

Group Type: ACTIVE_COMPARATOR

Tadalafil 5mg

Intervention Type: DRUG

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

Tamsulosin

Group Type: ACTIVE_COMPARATOR

Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Tadalafil 5mg

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

Intervention Type: 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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Vitamin C (ascorbic acid) 500mg tablets

Eligibility Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of Split

OTHER

Sponsor Role: lead

Responsible Party

Ivo Juginovic

Doctor of Medicine (MD), Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivo Juginović

Role: PRINCIPAL_INVESTIGATOR

University Hospital Split,Department of Urology

Marijan Šitum

Role: STUDY_DIRECTOR

University Hospital Split,Department of Urology

Sandro Glumac

Role: STUDY_DIRECTOR

University Hospital Split, Department of Anesthesiology and Intensive Care

Mario Duvnjak

Role: STUDY_CHAIR

University Hospital Split,Department of Urology

Marin Jelavić

Role: STUDY_CHAIR

University Hospital Split,Department of Urology

Ruben Kovač

Role: STUDY_CHAIR

University Hospital Split, Department of Anesthesiology and Intensive Care

Locations

University hospital of Splity

Split, Split-Dalmatia County, Croatia

Countries

Croatia

References

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.

Reference Type: RESULT

PMID: 31983605 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33819444 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25812823 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23876588 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23816815 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11696744 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14665353 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25430505 (View on PubMed)

Other Identifiers

UHSplit

Identifier Type: -

Identifier Source: org_study_id