Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709992
Recruitment Status : Suspended (Because of COVID-19 Crisis)
First Posted : October 17, 2018
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Amiri Hospital
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, Mansoura University

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 18, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Omnic




Primary Outcome Measures :
  1. Ureteral Stent Symptoms Questionnaire (USSQ) score [ Time Frame: 14 days ]
    Quantitative assessment of quality of life score


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 14 days ]
    Assessment of side effects of the drug used



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709992


Locations
Layout table for location information
Kuwait
Al-Amiri Hospital
Kuwait, Kuwait
Sponsors and Collaborators
Mansoura University
Amiri Hospital
Investigators
Layout table for investigator information
Study Chair: Abdullatif AL-Terki, MD Amiri Hospital - Kuwait
Layout table for additonal information
Responsible Party: Ahmed R. EL-Nahas, Professor of Urology, Mansoura University
ClinicalTrials.gov Identifier: NCT03709992    
Other Study ID Numbers: Trospium vs Tamsulosin
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed R. EL-Nahas, Mansoura University:
ureteral stent
USSQ
Tamsulosin
Trospium Chloride
Additional relevant MeSH terms:
Layout table for MeSH terms
Ureteral Obstruction
Ureteral Diseases
Urologic Diseases
Tamsulosin
Trospium chloride
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents