UrolithiasisPhase 4NCT07847866
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: The Impact of One Week of Preoperative Tamsulosin
A Phase 4 study testing Tamsulosin 0.4 MG in people with Urolithiasis and Tamsulosin, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
The goal of this clinical trial is to assess whether tamsulosin given one week prior to renal or ureteric stone surgery would improve the success rate of ureteral access sheath deployment and decrease ureteral injury Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Urolithiasis, Tamsulosin, Pre-operative
- What is being tested?
- Tamsulosin 0.4 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary retrograde intrarenal surgery for renal calculi
Who cannot join
- previous ureteral instrumentation or stenting or nephrostomy stent
- age < 21 years
- patients already receiving a1-adrenergic antagonists within 14 days of surgery
- pregnancy
- active urinary tract infection
- uncontrolled human-immunodeficiency virus infection
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- uncorrected coagulopathy
- known hypersensitivity to tamsulosin
- high-risk cardiovascular disease (defined as left ventricular outflow obstruction, myocardial infarction within the preceeding 90 days, unstable angina, cerebrovascular event within 6 months, or uncontrolled arrhythmias)
- chronic kidney disease stage 4-5
- severe hepatic impairment (Child-Pugh score ≥ 10)
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Sengkang General Hospital
Singapore
Singapore General Hospital
Singapore
About this study
The goal of this clinical trial is to assess whether tamsulosin given one week prior to renal or ureteric stone surgery would improve the success rate of ureteral access sheath deployment and decrease ureteral injury
- Conditions
- Urolithiasis, Tamsulosin, Pre-operative, Ureteral Access Sheath Placement, Ureteral Access Sheath
- Being tested
- Tamsulosin 0.4 MG, Control
- Keywords
- urolithiasis, tamsulosin, pre-operative, ureteral access sheath, endourology, URS
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.4 MGDrug
Pre-operative tamsulosin 400mcg for one week prior to operation
ControlDrug
Control, no medication (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Treatment with one week pre-operative tamsulosin Receives: Drug: Tamsulosin 0.4 MG |
| Control arm | Placebo comparator | Control arm Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
UAS placement success
Successful placement of a ureteral access sheath during index procedure
Measured: At the time of operation
Secondary outcomes (4)
operative duration
Measured: operation date, start time and end time
ureteral injury
graded according to the post-ureteroscopic lesion scale (PULS)
Measured: intraoperative
Stone-free rate (SFR)
Imaging evaluation for SFR using XR KUB or NCCT KUB
Measured: 90 days postoperatively
Medication adverse effects
Patient reported adverse effects
Measured: pre-operatively 1 week until operation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jun 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847866
- Sponsor's protocol ID
- 2019-2156
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: The Impact of One Week of Preoperative Tamsulosin
- ClinicalTrials.gov ID
- NCT07847866
- Acronym / sponsor ID
- 2019-2156
- Conditions
- Urolithiasis, Tamsulosin, Pre-operative, Ureteral Access Sheath Placement, Ureteral Access Sheath
- Keywords
- urolithiasis, tamsulosin, pre-operative, ureteral access sheath, endourology, URS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 29 Sep 2026 (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 assess whether tamsulosin given one week prior to renal or ureteric stone surgery would improve the success rate of ureteral access sheath deployment and decrease ureteral injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Tamsulosin 0.4 MGTreatment with one week pre-operative tamsulosin |
| Control arm | Placebo comparator | Drug: ControlControl arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled to undergo primary retrograde intrarenal surgery for renal calculi
Key exclusion criteria (11 listed)
- previous ureteral instrumentation or stenting or nephrostomy stent
- age < 21 years
- patients already receiving a1-adrenergic antagonists within 14 days of surgery
- pregnancy
- active urinary tract infection
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 0.4 MGPre-operative tamsulosin 400mcg for one week prior to operation | Drug | Treatment arm |
| ControlControl, no medication (standard of care) | Drug | Control arm |
Primary outcome
UAS placement success
Time frame: At the time of operation
Successful placement of a ureteral access sheath during index procedure
4 secondary outcomes
operative duration
Time frame: operation date, start time and end time
ureteral injury
Time frame: intraoperative
Stone-free rate (SFR)
Time frame: 90 days postoperatively
Medication adverse effects
Time frame: pre-operatively 1 week until operation date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Urolithiasis
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Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 0.4 MG in people with Urolithiasis and Tamsulosin, run by Singapore General Hospital at 2 sites in Singapore.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UAS placement success (time frame: At the time of operation). 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 29 Sep 2026.