Clinical trial

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

Name
Trospium vs Tamsulosin
Description
This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.
Trial arms
Trial start
2020-12-18
Estimated PCD
2024-08-01
Trial end
2024-11-01
Treatment
Trospium Chloride
30 mg of Trospium chloride tablet twice daily
Arms:
Trospium
Other names:
Spasmix
Tamsulosin
0.4 mg of Tamsulosin tablet once daily
Arms:
Tamsulosin
Other names:
Omnic
Size
200
Primary endpoint
Ureteral Stent Symptoms Questionnaire (USSQ) score
14 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-10-12

1 organization

2 products

3 indications

Indication
Ureter Stones
Indication
Quality of Life
Product
Tamsulosin