Tamsulosin Assisted Ureteral Access Sheath Insertion | NCT05197088

Studies
Tamsulosin Assisted Ureteral Access Sheath Insertion

NCT05197088

Sponsor

Sengkang General Hospital

Status

Unknown status

Last Update Posted

Jan 19, 2022Actual

Enrollment

110Estimated

Phase

Phase 3

Conditions

Renal Stone
Retrograde Intrarenal Surgery
Urolithiasis

Interventions

Tamsulosin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2022Estimated

Primary Completion Date

Mar 31, 2023Estimated

Completion Date

Jul 31, 2023Estimated

First Submitted Date

Jan 9, 2022

First Submission Date that Met QC Criteria

Jan 9, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2022

Last Update Posted Date

Jan 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 week of tamsulosin	Experimental	1 week of tamsulosin tablet 400mcg once a night	Drug: Tamsulosin
no additional medication	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin	Drug	1 week of tamsulosin	1 week of tamsulosin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
grade of ureteric injury after ureteral access sheath removal		during operation
post operative complications		3 months
stone free rate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053040	Nephrolithiasis
D052878	Urolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided