Trial | NCT03709992  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    200
This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.
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 Started
Dec 18
2020
Primary Completion
Aug 01
2024
Anticipated
Study Completion
Nov 01
2024
Anticipated
Last Update
Oct 12
2023

Drug Trospium Chloride

30 mg of Trospium chloride tablet twice daily

  • Other names: Spasmix

Drug Tamsulosin

0.4 mg of Tamsulosin tablet once daily

  • Other names: Omnic

Trospium Active Comparator

Patients will receive 30 mg of Trospium chloride tablet twice daily

Tamsulosin Active Comparator

Patients will receive 0.4 mg of Tamsulosin tablet once daily

Criteria 

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.
No Results Posted