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

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03709992

Enrollment

200

Registered

2018-10-17

Start date

2020-12-18

Completion date

2024-11-01

Last updated

2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureter Stone, Quality of Life, Ureter Obstruction

Keywords

ureteral stent, USSQ, Tamsulosin, Trospium Chloride

Brief summary

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

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.

Interventions

DRUGTrospium Chloride

30 mg of Trospium chloride tablet twice daily

DRUGTamsulosin

0.4 mg of Tamsulosin tablet once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Ureteral Stent Symptoms Questionnaire (USSQ) score	14 days	Quantitative assessment of quality of life score

Secondary

Measure	Time frame	Description
Adverse events	14 days	Assessment of side effects of the drug used

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026