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Clinical Trials/NCT07447518
NCT07447518
Completed
Early Phase 1

Comparison of Mirabegron ,Tamsulosin and Solifenacinin Relieving Double -J Stent Related Symptoms : Approspective Randmized Placebo Controlledtrial

Kafrelsheikh University1 site in 1 country535 target enrollmentStarted: September 22, 2022Last updated:
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InterventionsTadalafil 5mgsolidosinSolfenacinMirabegronPlacebo

Overview

Phase
Early Phase 1
Status
Completed
Enrollment
535
Locations
1
Primary Endpoint
Double j related symptoms
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group A : patients will receive tadalafil

Active Comparator

Intervention: Tadalafil 5mg (Drug)

Group B: patients will receive solidosin

Active Comparator

Intervention: solidosin (Drug)

Group C: patients will receive solfenacin

Active Comparator

Intervention: Solfenacin (Drug)

Group D: patients will receive mirabegron

Active Comparator

Intervention: Mirabegron (Drug)

Group E: patients will receive placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Double j related symptoms

Time Frame: Six weeks

Double j related symptoms questionnaire score

Secondary Outcomes

  • Sex matters related double j stent(Six weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elsayed Abdelhalim Elsayed

assistant lecturer, urology department, Kafrelsheikh university

Kafrelsheikh University

Study Sites (1)

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