Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy (NCT07276919) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy
China1,844 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range
40 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* History of severe bleeding disorders.
* Poorly controlled or unstable comorbidities such as hypertension or diabetes.
* Severe immunosuppression.
* Severe psychological disorders or uncooperative for the biopsy procedure.
* Active urinary tract infection or neurogenic bladder.
* Any other condition deemed by the investigator as unsuitable for participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of AUR
Timeframe: From biopsy to the 7th day after biopsy.