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Tamsulosin Assisted Ureteral Access Sheath Insertion

Primary Purpose

Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
Sengkang General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • renal stone undergoing retrograde intrarenal surgery

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1 week of tamsulosin

    no additional medication

    Arm Description

    1 week of tamsulosin tablet 400mcg once a night

    Outcomes

    Primary Outcome Measures

    successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)

    Secondary Outcome Measures

    grade of ureteric injury after ureteral access sheath removal
    post operative complications
    stone free rate
    need for additional procedures

    Full Information

    First Posted
    January 9, 2022
    Last Updated
    January 9, 2022
    Sponsor
    Sengkang General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05197088
    Brief Title
    Tamsulosin Assisted Ureteral Access Sheath Insertion
    Official Title
    Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 9, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    July 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sengkang General Hospital

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1 week of tamsulosin
    Arm Type
    Experimental
    Arm Description
    1 week of tamsulosin tablet 400mcg once a night
    Arm Title
    no additional medication
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin
    Intervention Description
    1 week of tamsulosin
    Primary Outcome Measure Information:
    Title
    successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
    Time Frame
    during operation
    Secondary Outcome Measure Information:
    Title
    grade of ureteric injury after ureteral access sheath removal
    Time Frame
    during operation
    Title
    post operative complications
    Time Frame
    3 months
    Title
    stone free rate
    Time Frame
    3 months
    Title
    need for additional procedures
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: renal stone undergoing retrograde intrarenal surgery Exclusion Criteria: not on tamsulosin or other alpha blockers regularly ureteral stricture concurrent ureteric stone

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Tamsulosin Assisted Ureteral Access Sheath Insertion

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