Back to resultsTrospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
Primary Purpose
Ureter Stone, Quality of Life, Ureter Obstruction
Status
Suspended
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Trospium Chloride
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Ureter Stone focused on measuring ureteral stent, USSQ, Tamsulosin, Trospium Chloride
Eligibility Criteria
Inclusion Criteria:
- Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney
Exclusion Criteria:
- 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.
Sites / Locations
- Ahmed R EL-Nahas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Trospium
Tamsulosin
Arm Description
Patients will receive 30 mg of Trospium chloride tablet twice daily
Patients will receive 0.4 mg of Tamsulosin tablet once daily
Outcomes
Primary Outcome Measures
Ureteral Stent Symptoms Questionnaire (USSQ) score
Quantitative assessment of quality of life score
Secondary Outcome Measures
Adverse events
Assessment of side effects of the drug used
Full Information
NCT ID
NCT03709992
First Posted
October 15, 2018
Last Updated
October 10, 2023
Sponsor
Mansoura University
Collaborators
Amiri Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03709992
Brief Title
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
Official Title
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Because of COVID-19 Crisis
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
Amiri Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureter Stone, Quality of Life, Ureter Obstruction
Keywords
ureteral stent, USSQ, Tamsulosin, Trospium Chloride
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trospium
Arm Type
Active Comparator
Arm Description
Patients will receive 30 mg of Trospium chloride tablet twice daily
Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Description
Patients will receive 0.4 mg of Tamsulosin tablet once daily
Intervention Type
Drug
Intervention Name(s)
Trospium Chloride
Other Intervention Name(s)
Spasmix
Intervention Description
30 mg of Trospium chloride tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Omnic
Intervention Description
0.4 mg of Tamsulosin tablet once daily
Primary Outcome Measure Information:
Title
Ureteral Stent Symptoms Questionnaire (USSQ) score
Description
Quantitative assessment of quality of life score
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Adverse events
Description
Assessment of side effects of the drug used
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullatif AL-Terki, MD
Organizational Affiliation
Amiri Hospital - Kuwait
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed R EL-Nahas
City
Mansoura
State/Province
Kuwait
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
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