NCT04325880

Brief Summary

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of three different drugs in treatment of ureteral stents related symptoms (Beta 3 adrenergic receptor agonist; Mirabegron 50mg) vs. (Alpha 1 adrenergic receptor antagonist; Tamsulosin 0.4mg) vs. (Anticholinergic; Solifenacin 10 mg) using validated symptoms questionnaires. In addition, adverse events of the utilized medications will be monitored during study period as a secondary objective.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

March 24, 2020

Last Update Submit

November 20, 2021

Conditions

Ureteral StentStent Related Symptoms

Keywords

Ureteral stoneUreteral stentStent related symptomsQuality of life

Outcome Measures

Primary Outcomes (1)

  • Improvement in stent related symptoms using ureteral stent symptoms questionnaire (USSQ)

    The effect of the assigned treatment on improvement of stent related symptoms will be assessed at the time of stent removal using ureteral stent symptoms questionnaire (USSQ)

    4 weeks

Secondary Outcomes (1)

  • Adverse event of medications

    4 weeks

Study Arms (4)

Placebo arm

PLACEBO COMPARATOR

Patients in this arm will receive a placebo formula

Drug: Placebo oral tablet

Mirabegron arm

ACTIVE COMPARATOR

Patients in this arm will receive Mirabegrone 50 mg once daily

Drug: Mirabegron 50 MG

Tamsulosin arm

ACTIVE COMPARATOR

Patients in this arm will receive tamsulosin o.4 mg once daily

Drug: Tamsulosin

Solifenacin arm

ACTIVE COMPARATOR

Patients in this arm will receive solifenacin 10 mg once daily

Drug: Solifenacin Succinate 10 MG

Interventions

Mirabegron 50 MGDRUG

Patients in this arm will receive Mirabegrone 50 MG once daily

Mirabegron arm
TamsulosinDRUG

Patients in this arm will receive Tamsulosin o.4 MG once daily

Tamsulosin arm
Solifenacin Succinate 10 MGDRUG

Patients in this arm will receive Solifenacin Succinate 10 MG once daily

Solifenacin arm
Placebo oral tabletDRUG

Patients in this arm will receive placebo oral tablet once daily

Placebo arm

Eligibility Criteria

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

You may qualify if:

  • Adult patients (aged 19-80 years)
  • Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.

You may not qualify if:

  • Patients with neurogenic bladder, OAB syndrome, and neurological and psychiatric diseases
  • Residual ureteral or renal stones after the procedure
  • Preoperative febrile UTI
  • pregnancy or breastfeeding
  • Bilateral ureteroscopic surgery
  • Single kidney
  • Chronic kidney disease
  • Cardiovascular or cerebrovascular disease
  • Hepatic dysfunction
  • History of pelvic surgery or irradiation
  • History of bladder or prostate surgery
  • Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
  • Preoperative indwelling of ureteral stent for relief of stone-related pain or sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Ureterolithiasis

Interventions

mirabegronTamsulosinSolifenacin Succinate

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Amr A Elsawy

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Elsawy

CONTACT

0502202222amrelsawy.unc@hotmail.com

Ahmed S Elhefnawy

CONTACT

0502202222a_s_elhefnawy@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 30, 2020

Study Start

December 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

EG(1)