What side effects are associated with this type of intervention?

Common treatments for Benign Prostatic Hyperplasia (BPH) include antifibrinolytic agents like Tranexamic Acid (TXA), 5α-reductase inhibitors such as finasteride and dutasteride, and various surgical interventions. TXA is generally well-tolerated but can cause side effects such as deep venous thrombosis, pulmonary embolism, and cerebrovascular events. Finasteride may reduce intraoperative bleeding but can lead to sexual dysfunction, including decreased libido and erectile dysfunction. Dutasteride appears to have no significant effect on bleeding but shares similar sexual side effects with finasteride. Surgical treatments, including transurethral resection of the prostate (TURP) and Holmium Laser Enucleation of the Prostate (HoLEP), can result in complications like hematuria, urinary incontinence, and infection.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Benign Prostatic Hyperplasia (BPH), including alpha blockers (e.g., tamsulosin, alfuzosin) and 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride). These medications help to relieve symptoms by relaxing the muscles of the prostate and bladder neck or by shrinking the prostate. While Tranexamic Acid (TXA) is not a standard treatment for BPH, it is being studied for its potential to reduce bleeding in surgical procedures like Holmium Laser Enucleation of the Prostate (HoLEP), which is used to treat BPH.

What other types of research exist?

As of 2024, promising novel alternatives to Tranexamic Acid (TXA) for Benign Prostatic Hyperplasia (BPH) patients include the use of newer antifibrinolytic agents such as Epsilon-Aminocaproic Acid (EACA) and advanced hemostatic agents like recombinant activated factor VII (rFVIIa). Additionally, innovations in surgical techniques, such as improved laser technologies and minimally invasive procedures, may also contribute to reduced bleeding and better outcomes for BPH patients.

← Back to Search

Antifibrinolytic Agent

Tranexamic Acid for Prostate Enlargement

Phase 4

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing if a medication called TXA can help patients who have prostate surgery go home the same day by reducing bleeding. The study focuses on patients undergoing a specific type of prostate surgery called HoLEP. TXA works by promoting blood clotting, which helps reduce bleeding and speeds up recovery. Tranexamic acid (TXA) has been used to manage bleeding in various surgeries, including orthopedic and gynecological procedures, but its efficacy in prostate surgeries like HoLEP is still being evaluated.

Who is the study for?

This trial is for males aged 18-89 who are undergoing a prostate surgery called HoLEP and can complete questionnaires. It's not for those with a history of blood clots, thrombosis risks, additional simultaneous procedures (except cystolitholapaxy), or allergies to Tranexamic acid.

What is being tested?

The study tests if Tranexamic acid (TXA), a drug that helps blood clot, can increase the rate of patients going home the same day after HoLEP surgery. The comparison is between patients receiving TXA and those who do not.

What are the potential side effects?

Possible side effects of TXA may include an increased risk of blood clots like deep vein thrombosis or pulmonary embolism, stroke events, and prolonged bleeding after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of Stay

Same-day Discharge Rate

Secondary study objectives

Adverse Events Related to TXA

Duration of Postoperative Hematuria

Number of Participants With Bleeding Complications

+1 more

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116

22%

Readmissions

14%

Postoperative infections

10%

Re-operations

Thromboembolic events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Tranexamic Group

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TXA intraoperativelyExperimental Treatment1 Intervention

Patients will receive intraoperative 1g TXA during the HoLEP procedure.

Group II: No TXA intraoperativelyActive Control1 Intervention

Patients will not receive intraoperative TXA during the HoLEP procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Benign Prostatic Hyperplasia (BPH) include alpha-adrenergic blockers, 5-alpha-reductase inhibitors, and surgical interventions. Alpha-adrenergic blockers, such as tamsulosin, work by relaxing the smooth muscles in the prostate and bladder neck, improving urine flow and reducing BPH symptoms. 5-alpha-reductase inhibitors, like finasteride, reduce the size of the prostate by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate growth. Surgical options, such as transurethral resection of the prostate (TURP), physically remove prostate tissue to relieve obstruction. Antifibrinolytic agents like Tranexamic Acid (TXA) are used during surgical procedures to promote clot formation and reduce bleeding, which is crucial for minimizing perioperative complications and improving recovery outcomes for BPH patients.