Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy
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
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
Treatments tested in this trial
- Tamsulosin 0.2mg
Treatment groups
1,844 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University First Hospital
Lead sponsor
Taiyuan Central Hospital of Shanxi Medical University
Collaborator
Source ClinicalTrials.gov