NCT07447518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 17, 2025

Last Update Submit

February 26, 2026

Conditions

Lower Urinary Tract Symptoms

Keywords

LUTSDouble j

Outcome Measures

Primary Outcomes (1)

  • Double j related symptoms

    Double j related symptoms questionnaire score

    Six weeks

Secondary Outcomes (1)

  • Sex matters related double j stent

    Six weeks

Study Arms (5)

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

Tadalafil 5mgDRUG

once daily 5mg

Group A : patients will receive tadalafil
solidosinDRUG

once daily

Group B: patients will receive solidosin
SolfenacinDRUG

once dialy

Group C: patients will receive solfenacin
MirabegronDRUG

once daily

Group D: patients will receive mirabegron
PlaceboDRUG

once daily

Group E: patients will receive placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • age less than 18 years
  • known over active bladder patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elsayed Abdelhalim

Zagazig, 44749, Egypt

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Tadalafilmirabegron

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer, urology department, Kafrelsheikh university

Study Record Dates

First Submitted

January 17, 2025

First Posted

March 3, 2026

Study Start

September 22, 2022

Primary Completion

January 1, 2023

Study Completion

September 1, 2023

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

EG(1)