Health TrialsbyHealthPanel

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

ConditionsAcute Urinary RetentionLUTS(Lower Urinary Tract Symptoms)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age40-85
SponsorPeking University First Hospital

About this trial

The goal of this clinical trial is to learn if the drug Tamsulosin Hydrochloride works to treat urination difficulties after a prostate biopsy in men.The main questions it aims to answer are:

* Does Tamsulosin Hydrochloride lower the rate of Acute Urinary Retention (inability to urinate) after a prostate biopsy? * Does Tamsulosin Hydrochloride improve participants' urination symptoms, quality of life, urine flow rate, and post-void residual urine volume?

Researchers will compare the drug group to a control group (receiving no preventive medication) to see if Tamsulosin Hydrochloride works to prevent urination problems.

Participants will:

* Be randomly assigned to either take Tamsulosin Hydrochloride or receive no preventive medication. * If in the drug group, take one capsule of Tamsulosin Hydrochloride every night, starting 3 days before the biopsy and continuing until 6 days after the biopsy (10 doses total). * Undergo a standard prostate biopsy procedure (either through the rectum or perineum). * Return to the clinic 7 days after the biopsy for a follow-up checkup, which will include questions about their symptoms (IPSS and QoL scores) and tests to measure urine flow and bladder emptying.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male, aged 40 to 85 years (inclusive).

Meets indications for prostate biopsy per clinical guidelines (e.g., suspicious nodule on digital rectal exam, suspicious lesion on imaging, tPSA >10 ng/mL, or tPSA 4-10 ng/mL with f/t <0.16 or PSAD >0.15).

Voluntarily participates and provides written informed consent.

Disqualifiers

Previous prostate surgery, urinary diversion, or intermittent catheterization.

Use of alpha-adrenergic blockers (e.g., Tamsulosin, Doxazosin) within one week prior to screening.

Known or suspected allergy/intolerance to Tamsulosin, or history of orthostatic hypotension.

Indwelling urinary catheter or suprapubic cystostomy tube at the time of biopsy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamsulosin 0.2mg

    Drug

    The experimental group will receive Tamsulosin Hydrochloride Sustained-Release Capsules (0.2 mg, once daily at night) starting 3 days before the biopsy and continuing until the 6th day after the procedure (10 doses total).

Treatment groups

1,844 Participants
are divided into 2 treatment groups
Group A: Tamsulosin GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of AUR

Incidence of Acute Urinary Retention (AUR)

Time frame
From biopsy to the 7th day after biopsy.

Secondary outcomes

1

IPSS

Change in International Prostate Symptom Score (IPSS)

Time frame
From baseline (pre-biopsy) to the 7th day after biopsy.
2

QoL

Change in Quality of Life (QoL) score related to urinary symptoms

Time frame
From baseline (pre-biopsy) to the 7th day after biopsy.
3

Qmax

Maximum urinary flow rate (Qmax)

Time frame
From baseline (pre-biopsy) to the 7th day after biopsy.
4

PVR

Post-void residual (PVR) urine volume

Time frame
From baseline (pre-biopsy) to the 7th day after biopsy.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Taiyuan Central Hospital of Shanxi Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: