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

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03709992

Collaborator

Amiri Hospital (Other)

200

Enrollment

Location

Arms

10.4

Anticipated Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureter Stone Quality of Life Ureter Obstruction	Drug: Trospium Chloride Drug: Tamsulosin	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 18, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Trospium Patients will receive 30 mg of Trospium chloride tablet twice daily	Drug: Trospium Chloride 30 mg of Trospium chloride tablet twice daily Other Names: Spasmix
Active Comparator: Tamsulosin Patients will receive 0.4 mg of Tamsulosin tablet once daily	Drug: Tamsulosin 0.4 mg of Tamsulosin tablet once daily Other Names: Omnic

Arm

Intervention/Treatment

Active Comparator: Trospium

Patients will receive 30 mg of Trospium chloride tablet twice daily

Drug: Trospium Chloride

30 mg of Trospium chloride tablet twice daily

Other Names:

Spasmix

Active Comparator: Tamsulosin

Patients will receive 0.4 mg of Tamsulosin tablet once daily

Drug: Tamsulosin

0.4 mg of Tamsulosin tablet once daily

Other Names:

Omnic

Outcome Measures

Primary Outcome Measures

Ureteral Stent Symptoms Questionnaire (USSQ) score [14 days]
Quantitative assessment of quality of life score

Secondary Outcome Measures

Adverse events [14 days]
Assessment of side effects of the drug used

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.