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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2024-11-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ureter Stone Quality of Life Ureter Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Trospium

Patients will receive 30 mg of Trospium chloride tablet twice daily

Group Type ACTIVE_COMPARATOR

Trospium Chloride

Intervention Type DRUG

30 mg of Trospium chloride tablet twice daily

Tamsulosin

Patients will receive 0.4 mg of Tamsulosin tablet once daily

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

0.4 mg of Tamsulosin tablet once daily

Interventions

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Trospium Chloride

30 mg of Trospium chloride tablet twice daily

Intervention Type DRUG

Tamsulosin

0.4 mg of Tamsulosin tablet once daily

Intervention Type DRUG

Other Intervention Names

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Spasmix Omnic

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No