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CompletedNCT07847866Updated Sep 29, 2026

Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: The Impact of One Week of Preoperative Tamsulosin

A Phase 4 interventional study of Tamsulosin 0.4 MG and Control in Urolithiasis, Tamsulosin and Pre-operative, sponsored by Singapore General Hospital. Completed at 2 sites in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Singapore General Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jun 2023, registered Sep 2026).
Updated Sep 29, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Urolithiasis
  • Tamsulosin
  • Pre-operative
  • Ureteral Access Sheath Placement
  • Ureteral Access Sheath

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Keywords

  • urolithiasis
  • tamsulosin
  • pre-operative
  • ureteral access sheath
  • endourology
  • URS
03

In context

Urolithiasis

278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.

This study's enrollment of 111 is above the median of 100 across 197 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Scheduled to undergo primary retrograde intrarenal surgery for renal calculi

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    Treatment arm

    Treatment with one week pre-operative tamsulosin

    Drug: Tamsulosin 0.4 MG

  • Placebo comparator
    Control arm

    Control arm

    Drug: Control

Interventions

  • DrugTamsulosin 0.4 MG

    Pre-operative tamsulosin 400mcg for one week prior to operation

  • DrugControl

    Control, no medication (standard of care)

06

What researchers measure

Primary outcomes

  1. UAS placement success

    Successful placement of a ureteral access sheath during index procedure

    Time frame: At the time of operation

Secondary outcomes

  1. operative duration

    Time frame: operation date, start time and end time

  2. ureteral injury

    graded according to the post-ureteroscopic lesion scale (PULS)

    Time frame: intraoperative

  3. Stone-free rate (SFR)

    Imaging evaluation for SFR using XR KUB or NCCT KUB

    Time frame: 90 days postoperatively

  4. Medication adverse effects

    Patient reported adverse effects

    Time frame: pre-operatively 1 week until operation date

07

Study locations

2 sites
  • Sengkang General Hospital
    Singapore, Singapore
  • Singapore General Hospital
    Singapore, Singapore
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07847866
Lead sponsor
Singapore General Hospital
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Jun 1, 2023
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025
Last update
Sep 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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