Trospium Chloride vs Tamsulosin in Treatment of Ureteral... | NCT03709992

Studies
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:

NCT03709992

Sponsor

Mansoura University

Status

Suspended

Last Update Posted

Oct 12, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Ureter Stone
Quality of Life
Ureter Obstruction

Interventions

Trospium Chloride
Tamsulosin

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Because of COVID-19 Crisis

Expanded Access Info

Start Date

Dec 18, 2020Actual

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Nov 1, 2024Estimated

First Submitted Date

Oct 15, 2018

First Submission Date that Met QC Criteria

Oct 15, 2018

First Posted Date

Oct 17, 2018Actual

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

Oct 10, 2023

Last Update Posted Date

Oct 12, 2023Actual

Name	Class
Amiri Hospital	OTHER_GOV

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

This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.

Detailed Description

Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive 30 mg of Trospium chloride tablet twice daily, while group 2 patients will receive 0.4 mg of Tamsulosin tablet once daily, until the stent is removed. Ureteral Stent Symptoms Questionnaire (USSQ) will be used to evaluate the symptoms of the patients with DJ stent after 2 weeks of inserting the stent.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trospium	Active Comparator	Patients will receive 30 mg of Trospium chloride tablet twice daily	Drug: Trospium Chloride
Tamsulosin	Active Comparator	Patients will receive 0.4 mg of Tamsulosin tablet once daily	Drug: Tamsulosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trospium Chloride	Drug	30 mg of Trospium chloride tablet twice daily	Trospium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ureteral Stent Symptoms Questionnaire (USSQ) score	Quantitative assessment of quality of life score	14 days

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Assessment of side effects of the drug used	14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney

Exclusion Criteria:

Patients with hypersensitivity to either Trospium chloride or Tamsulosin
Patients with complications after DJ insertion (such as fever, hematuria, perforation, stent migration).
Patients receiving alpha blockers or anticholinergic medications for any other reason.
Patients with history of orthostatic hypotension.
Pregnant or breastfeeding females.
Patients with hepatic impairment (Child-Pugh score >9).
Patients with severe renal impairment with creatinine clearance of less than 15 mL/min.
Patients with narrow-angle glaucoma.
Patients with history of urinary retention or gastric retention.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 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

Name	Affiliation	Role
Abdullatif AL-Terki, MD	Amiri Hospital - Kuwait	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed R EL-Nahas		Al Mansurah	Kuwait		Egypt

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
D053039	Ureterolithiasis
D014517	Ureteral Obstruction

Ancestor Terms

ID	Term
D014515	Ureteral 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
C003330	trospium chloride
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided