Medical Expulsive Therapy Post-SWL For Renal Stones | NCT05032287

Studies
Medical Expulsive Therapy Post-SWL For Renal Stones

NCT05032287

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Sep 2, 2021Actual

Enrollment

235Actual

Phase

Not Applicable

Conditions

Urologic Diseases
Urolithiasis
Stone, Kidney

Interventions

Tamsulosin
Placebo

Countries

Egypt

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Aug 25, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Sep 2, 2021Actual

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

Aug 30, 2021

Last Update Posted Date

Sep 2, 2021Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

235Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tamsulosin	Active Comparator	tamsulosin 0.4 mg once daily	Drug: Tamsulosin
Placeb	Placebo Comparator	Placebo once daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin	Drug	Tamsulosin 0.4 mg once daily	tamsulosin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone free rate defined as patient free of any stone residual	assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)	at 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Renal stone ≤ 20 mm.
Lower calyceal stone ≤ 15 mm

Exclusion Criteria:

Women with known or suspected pregnancy or breastfeeding.
History of alpa-blockers (more than 7 days prior to study participation)
History of ureteral stricture
Multiple (that is more than 2) stones
Stone in solitary kidney (either anatomically or functionally).
Presence of urinary sepsis.
Estimated glomerular filtration rate < 30 ml/min
Contraindication or allergy to tamsulosin

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center		Al Mansurah	Aldakahlia	35516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D014570	Urologic Diseases
D052878	Urolithiasis
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

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