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

Mansoura University

Status: Suspended

Conditions: Quality of Life; Ureter Obstruction; Ureter Stone

Treatments: Drug: Trospium Chloride; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT03709992

Trospium vs Tamsulosin

Details and patient eligibility

About

This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Trospium

Active Comparator group

Description:

Patients will receive 30 mg of Trospium chloride tablet twice daily

Treatment:

Drug: Trospium Chloride

Tamsulosin

Active Comparator group

Description:

Patients will receive 0.4 mg of Tamsulosin tablet once daily

Treatment:

Drug: Tamsulosin