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NCT03709992 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03709992
Other study ID # Trospium vs Tamsulosin
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date December 18, 2020
Est. completion date November 1, 2024

Study information
Verified date October 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Suspended
Enrollment 200
Est. completion date November 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Trospium Chloride
30 mg of Trospium chloride tablet twice daily
• Tamsulosin
0.4 mg of Tamsulosin tablet once daily

Locations
Country Name City State
Egypt Ahmed R EL-Nahas Mansoura Kuwait

Sponsors (2)
Lead Sponsor Collaborator
Mansoura University Amiri Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ureteral Stent Symptoms Questionnaire (USSQ) score Quantitative assessment of quality of life score 14 days
Secondary Adverse events Assessment of side effects of the drug used 14 days
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