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

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ClinicalTrials.gov Identifier: NCT03709992
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : December 29, 2020
Sponsor:
Collaborator:
Amiri Hospital
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, Mansoura University

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 17, 2018
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE December 18, 2020
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Ureteral Stent Symptoms Questionnaire (USSQ) score [ Time Frame: 14 days ]
Quantitative assessment of quality of life score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Adverse events [ Time Frame: 14 days ]
Assessment of side effects of the drug used
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
Official Title  ICMJE Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Ureter Stone
  • Quality of Life
  • Ureter Obstruction
Intervention  ICMJE
  • Drug: Trospium Chloride
    30 mg of Trospium chloride tablet twice daily
    Other Name: Spasmix
  • Drug: Tamsulosin
    0.4 mg of Tamsulosin tablet once daily
    Other Name: Omnic
Study Arms  ICMJE
  • Active Comparator: Trospium
    Patients will receive 30 mg of Trospium chloride tablet twice daily
    Intervention: Drug: Trospium Chloride
  • Active Comparator: Tamsulosin
    Patients will receive 0.4 mg of Tamsulosin tablet once daily
    Intervention: Drug: Tamsulosin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed R Elnahas, MD 0096555754386 ar_el_nahas@yahoo.com
Contact: Majd M Alkabbani, MD 0096596987198 majd.qabbani@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries Kuwait
 
Administrative Information
NCT Number  ICMJE NCT03709992
Other Study ID Numbers  ICMJE Trospium vs Tamsulosin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed R. EL-Nahas, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Amiri Hospital
Investigators  ICMJE
Study Chair: Abdullatif AL-Terki, MD Amiri Hospital - Kuwait
PRS Account Mansoura University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP