Tamsulosin Assisted Ureteral Access Sheath Insertion

January 9, 2022 updated by: Sundaram Palaniappan, Sengkang General Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • renal stone undergoing retrograde intrarenal surgery

Exclusion Criteria:

  • not on tamsulosin or other alpha blockers regularly
  • ureteral stricture
  • concurrent ureteric stone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 week of tamsulosin
1 week of tamsulosin tablet 400mcg once a night
Drug: Tamsulosin
1 week of tamsulosin
No Intervention: no additional medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
Time Frame: during operation
during operation

Secondary Outcome Measures

Outcome Measure
Time Frame
stone free rate
Time Frame: 3 months
3 months
grade of ureteric injury after ureteral access sheath removal
Time Frame: during operation
during operation
post operative complications
Time Frame: 3 months
3 months
need for additional procedures
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sengkang General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 9, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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