Renal StonePhase 3NCT05197088
Tamsulosin Assisted Ureteral Access Sheath Insertion
A Phase 3 study testing Tamsulosin in people with Renal Stone and Retrograde Intrarenal Surgery, run by Sengkang General Hospital at 1 site in Singapore.
Trial summary
Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2022to 31 Aug 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal stone undergoing retrograde intrarenal surgery
Who cannot join
- not on tamsulosin or other alpha blockers regularly
- ureteral stricture
- concurrent ureteric stone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin
Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease
- Conditions
- Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis
- Being tested
- Tamsulosin
- Medical subject headings
- Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
1 week of tamsulosin
| Study group | Role | What they receive |
|---|---|---|
| 1 week of tamsulosin | Experimental | 1 week of tamsulosin tablet 400mcg once a night Receives: Drug: Tamsulosin |
| no additional medication | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
Measured: during operation
Secondary outcomes (4)
grade of ureteric injury after ureteral access sheath removal
Measured: during operation
post operative complications
Measured: 3 months
stone free rate
Measured: 3 months
need for additional procedures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2025
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sundaram Palaniappan, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197088
- Sponsor's protocol ID
- 2019/2156
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 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 Pre-operative Tamsulosin
- ClinicalTrials.gov ID
- NCT05197088
- Acronym / sponsor ID
- 2019/2156
- Conditions
- Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Jan 2022 (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.
Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 week of tamsulosin | Experimental | Drug: Tamsulosin1 week of tamsulosin tablet 400mcg once a night |
| no additional medication | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- renal stone undergoing retrograde intrarenal surgery
Key exclusion criteria (3 listed)
- not on tamsulosin or other alpha blockers regularly
- ureteral stricture
- concurrent ureteric stone
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 |
|---|---|---|
| Tamsulosin1 week of tamsulosin | Drug | 1 week of tamsulosin |
Primary outcome
number of patients with successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
Time frame: during operation
4 secondary outcomes
grade of ureteric injury after ureteral access sheath removal
Time frame: during operation
post operative complications
Time frame: 3 months
stone free rate
Time frame: 3 months
need for additional procedures
Time frame: 3 months
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 30 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin in people with Renal Stone and Retrograde Intrarenal Surgery, run by Sengkang General Hospital at 1 site 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 3 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 30 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 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
number of patients with successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy) (time frame: during 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 30 Sep 2026.