NCT05197088

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

January 9, 2022

Last Update Submit

January 9, 2022

Conditions

Renal StoneRetrograde Intrarenal SurgeryUrolithiasis

Outcome Measures

Primary Outcomes (1)

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

    during operation

Secondary Outcomes (4)

  • grade of ureteric injury after ureteral access sheath removal

    during operation

  • post operative complications

    3 months

  • stone free rate

    3 months

  • need for additional procedures

    3 months

Study Arms (2)

1 week of tamsulosin

EXPERIMENTAL

1 week of tamsulosin tablet 400mcg once a night

Drug: Tamsulosin

no additional medication

NO INTERVENTION

Interventions

TamsulosinDRUG

1 week of tamsulosin

1 week of tamsulosin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal stone undergoing retrograde intrarenal surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NephrolithiasisUrolithiasis

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 19, 2022

Study Start

January 9, 2022

Primary Completion

March 31, 2023

Study Completion

July 31, 2023

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share