Quality of Life Clinical Trial
Official title:
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
Verified date | October 2023 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ahmed R EL-Nahas | Mansoura | Kuwait |
Lead Sponsor | Collaborator |
---|---|
Mansoura University | Amiri Hospital |
Egypt,
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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