Ureter StoneNCT03709992
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
A study testing Trospium Chloride and Tamsulosin in people with Ureter Stone and Quality of Life, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ureter Stone, Quality of Life, Ureter Obstruction
- What is being tested?
- Trospium Chloride and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2020to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.
Read the 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.
- Conditions
- Ureter Stone, Quality of Life, Ureter Obstruction
- Being tested
- Trospium Chloride, Tamsulosin
- Keywords
- ureteral stent, USSQ, Tamsulosin, Trospium Chloride
- Medical subject headings
- Ureterolithiasis, Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trospium ChlorideDrug
Also called Spasmix
30 mg of Trospium chloride tablet twice daily
TamsulosinDrug
Also called Omnic
0.4 mg of Tamsulosin tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Trospium | Active comparator | Patients will receive 30 mg of Trospium chloride tablet twice daily Receives: Drug: Trospium Chloride |
| Tamsulosin | Active comparator | Patients will receive 0.4 mg of Tamsulosin tablet once daily Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral Stent Symptoms Questionnaire (USSQ) score
Quantitative assessment of quality of life score
Measured: 14 days
Secondary outcomes (1)
Adverse events
Assessment of side effects of the drug used
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start18 Dec 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Why it stopped: Because of COVID-19 Crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter StoneStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Amiri Hospital
- Responsible party
- Principal investigator, Ahmed R. EL-Nahas, Mansoura University
- Investigators
- Abdullatif AL-Terki, MD, Study chair, Amiri Hospital - Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709992
- Sponsor's protocol ID
- Trospium vs Tamsulosin
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2018
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03709992
- Acronym / sponsor ID
- Trospium vs Tamsulosin
- Conditions
- Ureter Stone, Quality of Life, Ureter Obstruction
- Keywords
- ureteral stent, USSQ, Tamsulosin, Trospium Chloride
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because of COVID-19 Crisis
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Amiri Hospital
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trospium | Active comparator | Drug: Trospium ChloridePatients will receive 30 mg of Trospium chloride tablet twice daily |
| Tamsulosin | Active comparator | Drug: TamsulosinPatients will receive 0.4 mg of Tamsulosin tablet once daily |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trospium ChlorideAlso: Spasmix30 mg of Trospium chloride tablet twice daily | Drug | Trospium |
| TamsulosinAlso: Omnic0.4 mg of Tamsulosin tablet once daily | Drug | Tamsulosin |
Primary outcome
Ureteral Stent Symptoms Questionnaire (USSQ) score
Time frame: 14 days
Quantitative assessment of quality of life score
1 secondary outcome
Adverse events
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullatif AL-Terki, MD study chair
Amiri Hospital - Kuwait
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trospium Chloride and Tamsulosin in people with Ureter Stone and Quality of Life, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral Stent Symptoms Questionnaire (USSQ) score (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.