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

NCT07847866 | Completed Phase 4

• 1 other identifier: 2019-2156
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

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

Keywords

urolithiasis; tamsulosin; pre-operative; ureteral access sheath; endourology; URS

Outcome Measures

Primary Outcomes (1)

• UAS placement success

  Successful placement of a ureteral access sheath during index procedure

  At the time of operation

Secondary Outcomes (4)

• operative duration

  operation date, start time and end time

• ureteral injury

  intraoperative

• Stone-free rate (SFR)

  90 days postoperatively

• Medication adverse effects

  pre-operatively 1 week until operation date

Study Arms (2)

Treatment arm

EXPERIMENTAL

Treatment with one week pre-operative tamsulosin

Drug: Tamsulosin 0.4 MG

Control arm

PLACEBO COMPARATOR

Control arm

Drug: Control

Interventions

Control DRUG

Control, no medication (standard of care)

Control arm

Tamsulosin 0.4 MG DRUG

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

Treatment arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo primary retrograde intrarenal surgery for renal calculi

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Sengkang General Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)