Acute Urinary RetentionPhase 4NCT07276919
Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy
A Phase 4 study testing Tamsulosin 0.2mg in people with Acute Urinary Retention and LUTS(Lower Urinary Tract Symptoms), run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Acute Urinary Retention, LUTS(Lower Urinary Tract Symptoms)
- What is being tested?
- Tamsulosin 0.2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,844 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital, Urology Department
Beijing, Outside U.S./Canada, 100034
Kai Dr. Zhang, Doctor degree, 0086-10-83575602, kaizhangpku@163.com
About this study
Official title: Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy: A Multicenter, Randomized, Controlled, Open-Label Study
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?
Read more
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.
Read the detailed description
This study is designed as a multicenter, randomized, controlled, open-label trial. Participants will be randomized 1:1 into two groups using a block randomization method. 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). The control group will not receive Tamsulosin during this perioperative period. All patients will undergo standard pre-biopsy preparations, including bowel preparation and prophylactic antibiotics. The primary endpoint, Acute Urinary Retention (AUR) incidence, along with secondary endpoints (IPSS, QoL, urinary flow rate, post-void residual urine), will be assessed on the 7th day after the biopsy. Safety indicators, such as the incidence of adverse events like orthostatic hypotension and falls, will also be monitored.
- Being tested
- Tamsulosin 0.2mg
- Keywords
- acute urinary retention, LUTS(Lower urinary tract symptoms), tamsulosin, prostate biopsy
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.2mgDrug
Also called Tamsulosin Hydrochloride Sustained-Release Capsules
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).
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin Group | Experimental | 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). Receives: Drug: Tamsulosin 0.2mg |
| Control Group | No intervention | Participants will not receive Tamsulosin during the perioperative period but will undergo the standard prostate biopsy procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AUR
Incidence of Acute Urinary Retention (AUR)
Measured: From biopsy to the 7th day after biopsy.
Secondary outcomes (4)
IPSS
Change in International Prostate Symptom Score (IPSS)
Measured: From baseline (pre-biopsy) to the 7th day after biopsy.
QoL
Change in Quality of Life (QoL) score related to urinary symptoms
Measured: From baseline (pre-biopsy) to the 7th day after biopsy.
Qmax
Maximum urinary flow rate (Qmax)
Measured: From baseline (pre-biopsy) to the 7th day after biopsy.
PVR
Post-void residual (PVR) urine volume
Measured: From baseline (pre-biopsy) to the 7th day after biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,844 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taiyuan Central Hospital of Shanxi Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276919
- Sponsor's protocol ID
- 20251018
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy: A Multicenter, Randomized, Controlled, Open-Label Study
- ClinicalTrials.gov ID
- NCT07276919
- Acronym / sponsor ID
- 20251018
- Keywords
- acute urinary retention, LUTS(Lower urinary tract symptoms), tamsulosin, prostate biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,844 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Taiyuan Central Hospital of Shanxi Medical University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed as a multicenter, randomized, controlled, open-label trial. Participants will be randomized 1:1 into two groups using a block randomization method. 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). The control group will not receive Tamsulosin during this perioperative period. All patients will undergo standard pre-biopsy preparations, including bowel preparation and prophylactic antibiotics. The primary endpoint, Acute Urinary Retention (AUR) incidence, along with secondary endpoints (IPSS, QoL, urinary flow rate, post-void residual urine), will be assessed on the 7th day after the biopsy. Safety indicators, such as the incidence of adverse events like orthostatic hypotension and falls, will also be monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Group | Experimental | Drug: Tamsulosin 0.2mgThe 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). |
| Control Group | No intervention | –Participants will not receive Tamsulosin during the perioperative period but will undergo the standard prostate biopsy procedure. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin 0.2mgAlso: Tamsulosin Hydrochloride Sustained-Release CapsulesThe 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). | Drug | Tamsulosin Group |
Primary outcome
Incidence of AUR
Time frame: From biopsy to the 7th day after biopsy.
Incidence of Acute Urinary Retention (AUR)
4 secondary outcomes
IPSS
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
QoL
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
Qmax
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
PVR
Time frame: From baseline (pre-biopsy) to the 7th day after biopsy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin 0.2mg in people with Acute Urinary Retention and LUTS(Lower Urinary Tract Symptoms), run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Zhang, Doctor Degree (+8618909870823, yaokaifeng@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AUR (time frame: From biopsy to the 7th day after biopsy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.