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

Not Applicable

Suspended

• Conditions: Ureter Stone; Quality of Life; Ureter Obstruction
• Interventions: Drug: Trospium Chloride; Drug: Tamsulosin

• Registration Number: NCT03709992
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2020-12-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Primary Completion: 2024-08-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trospium	Trospium Chloride	Patients will receive 30 mg of Trospium chloride tablet twice daily
Tamsulosin	Tamsulosin	Patients will receive 0.4 mg of Tamsulosin tablet once daily

Primary Outcome Measures

Name	Time	Method
Ureteral Stent Symptoms Questionnaire (USSQ) score	14 days	Quantitative assessment of quality of life score

Secondary Outcome Measures

Name	Time	Method
Adverse events	14 days	Assessment of side effects of the drug used

Trial Locations

Locations (1)

Ahmed R EL-Nahas; 🇪🇬 Mansoura, Kuwait, Egypt