NCT03709992

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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

October 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 18, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

October 15, 2018

Last Update Submit

October 10, 2023

Conditions

Ureter StoneQuality of LifeUreter Obstruction

Keywords

ureteral stentUSSQTamsulosinTrospium Chloride

Outcome Measures

Primary Outcomes (1)

  • Ureteral Stent Symptoms Questionnaire (USSQ) score

    Quantitative assessment of quality of life score

    14 days

Secondary Outcomes (1)

  • Adverse events

    14 days

Study Arms (2)

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

Trospium ChlorideDRUG

30 mg of Trospium chloride tablet twice daily

Also known as: Spasmix
Trospium
TamsulosinDRUG

0.4 mg of Tamsulosin tablet once daily

Also known as: Omnic
Tamsulosin

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed R EL-Nahas

Al Mansurah, Kuwait, Egypt

Location

MeSH Terms

Conditions

UreterolithiasisUreteral Obstruction

Interventions

trospium chlorideTamsulosin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Abdullatif AL-Terki, MD

    Amiri Hospital - Kuwait

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 17, 2018

Study Start

December 18, 2020

Primary Completion

August 1, 2024

Study Completion

November 1, 2024

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)