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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ureter Stone, Quality of Life, Ureter Obstruction

Intervention / Treatment
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* Drug: Trospium Chloride
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trospium<br>Patients will receive 30 mg of Trospium chloride tablet twice daily | Drug: Trospium Chloride<br>* 30 mg of Trospium chloride tablet twice daily<br>* Other names: Spasmix;|
| Active Comparator: Tamsulosin<br>Patients will receive 0.4 mg of Tamsulosin tablet once daily | Drug: Tamsulosin<br>* 0.4 mg of Tamsulosin tablet once daily<br>* Other names: Omnic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral stent, USSQ, Tamsulosin, Trospium Chloride