Double j Stent Related Symptoms | NCT07447518

Studies
Double j Stent Related Symptoms

NCT07447518

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Mar 3, 2026Actual

Enrollment

535Actual

Phase

Early Phase 1

Conditions

Lower Urinary Tract Symptoms

Interventions

Tadalafil 5mg
solidosin
Solfenacin
Mirabegron
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

Feb 2026

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 22, 2022Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Sep 1, 2023Actual

First Submitted Date

Jan 17, 2025

First Submission Date that Met QC Criteria

Feb 26, 2026

First Posted Date

Mar 3, 2026Actual

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

Feb 26, 2026

Last Update Posted Date

Mar 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elsayed Abdelhalim Elsayed, assistant lecturer, urology department, Kafrelsheikh university, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

In urology, ureteral stents are used to treat obstructive diseases. Hematuria (54%), fever, discomfort, and lower urinary system symptoms are the predominant symptoms related to ureteral stent.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

535Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group A : patients will receive tadalafil	Active Comparator	Drug: Tadalafil 5mg
Group B: patients will receive solidosin	Active Comparator	Drug: solidosin
Group C: patients will receive solfenacin	Active Comparator	Drug: Solfenacin
Group D: patients will receive mirabegron	Active Comparator	Drug: Mirabegron
Group E: patients will receive placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tadalafil 5mg	Drug	once daily 5mg	Group A : patients will receive tadalafil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Double j related symptoms	Double j related symptoms questionnaire score	Six weeks

Secondary Outcomes

Measure	Description	Time Frame
Sex matters related double j stent	Sex matters related stent	Six weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age above 18 years
any patient need post urs or pcnl double stent

Exclusion Criteria:

age less than 18 years
known over active bladder patient

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
Elsayed Abdelhalim		Zagazig		44749	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068581	Tadalafil
C520025	mirabegron

Ancestor Terms

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided