Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:

October 10, 2023 updated by: Ahmed R. EL-Nahas, Mansoura University

Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial

This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive 30 mg of Trospium chloride tablet twice daily, while group 2 patients will receive 0.4 mg of Tamsulosin tablet once daily, until the stent is removed. Ureteral Stent Symptoms Questionnaire (USSQ) will be used to evaluate the symptoms of the patients with DJ stent after 2 weeks of inserting the stent.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kuwait
      • Mansoura, Kuwait, Egypt
        • Ahmed R EL-Nahas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with hypersensitivity to either Trospium chloride or Tamsulosin
  2. Patients with complications after DJ insertion (such as fever, hematuria, perforation, stent migration).
  3. Patients receiving alpha blockers or anticholinergic medications for any other reason.
  4. Patients with history of orthostatic hypotension.
  5. Pregnant or breastfeeding females.
  6. Patients with hepatic impairment (Child-Pugh score >9).
  7. Patients with severe renal impairment with creatinine clearance of less than 15 mL/min.
  8. Patients with narrow-angle glaucoma.
  9. Patients with history of urinary retention or gastric retention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trospium
Patients will receive 30 mg of Trospium chloride tablet twice daily
Drug: Trospium Chloride
30 mg of Trospium chloride tablet twice daily
Other Names:
  • Spasmix
Active Comparator: Tamsulosin
Patients will receive 0.4 mg of Tamsulosin tablet once daily
Drug: Tamsulosin
0.4 mg of Tamsulosin tablet once daily
Other Names:
  • Omnic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ureteral Stent Symptoms Questionnaire (USSQ) score
Time Frame: 14 days
Quantitative assessment of quality of life score
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 14 days
Assessment of side effects of the drug used
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Collaborators

Amiri Hospital

Investigators

  • Study Chair: Abdullatif AL-Terki, MD, Amiri Hospital - Kuwait

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trospium vs Tamsulosin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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