UreterolithiasisPhase 4NCT03614052
Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy
A Phase 4 study testing Tamsulosin Hydrochloride 0.4 milligrams in people with Ureterolithiasis and Ureteral Calculi, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureterolithiasis, Ureteral Calculi, Urolithiasis
- What is being tested?
- Tamsulosin Hydrochloride 0.4 milligrams
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2018to 26 Jan 2020
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with urolithiasis undergoing to endoscopic ureterolithotomy
Who cannot join
- Patients with previous ureteral catheter
- Patients with allergy to tamsulosin
- Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis
- Multiple ureterolithiasis
- Patients with impairment of their mental status
- Patients with open surgeries in the affected ureter or urinary diversion
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Pontificia Universidad católica de Chile
Santiago, Santiago Metropolitan
About this study
Official title: Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
This a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.
Read the detailed description
Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.
Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.
- Conditions
- Ureterolithiasis, Ureteral Calculi, Urolithiasis
- Being tested
- Tamsulosin Hydrochloride 0.4 milligrams, Placebo Oral Tablet
- Medical subject headings
- Ureterolithiasis, Ureteral Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Hydrochloride 0.4 milligramsDrug
Also called tamsulosin0,4mg
Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis
Placebo Oral TabletDrug
Also called placebo
Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin hydrochloride | Experimental | Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy Receives: Drug: Tamsulosin Hydrochloride 0.4 milligrams |
| Placebo oral tablet | Placebo comparator | Placebo oral tablets by mouth per day for 5 days before ureteroscopy Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
stone free rate after ureteroscopic management of urolithiasis
Measured: 30 days
Secondary outcomes (1)
failed ureteroscopy rate
failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter
Measured: 05 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jun 2018
- Primary completion26 Jan 2020
- Study completion26 Jan 2020
Why it stopped: Problems with the number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreterolithiasisStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaston Astroza, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614052
- Sponsor's protocol ID
- 171229002
- Status last verified
- Jan 2020
- First submitted
- 30 Jul 2018
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
- ClinicalTrials.gov ID
- NCT03614052
- Acronym / sponsor ID
- 171229002
- Conditions
- Ureterolithiasis, Ureteral Calculi, Urolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems with the number of participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 26 Jan 2020 (actual)
- First posted
- 3 Aug 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 a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.
Detailed description
Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.
Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamsulosin hydrochloride | Experimental | Drug: Tamsulosin Hydrochloride 0.4 milligramsTamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy |
| Placebo oral tablet | Placebo comparator | Drug: Placebo Oral TabletPlacebo oral tablets by mouth per day for 5 days before ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with urolithiasis undergoing to endoscopic ureterolithotomy
Key exclusion criteria (7 listed)
- Patients with previous ureteral catheter
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 |
|---|---|---|
| Tamsulosin Hydrochloride 0.4 milligramsAlso: tamsulosin0,4mgTamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis | Drug | tamsulosin hydrochloride |
| Placebo Oral TabletAlso: placeboPlacebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis | Drug | Placebo oral tablet |
Primary outcome
stone free rate
Time frame: 30 days
stone free rate after ureteroscopic management of urolithiasis
1 secondary outcome
failed ureteroscopy rate
Time frame: 05 days
Results and safety
The study was stopped early (reason given: Problems with the number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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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.
Gaston Astroza, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin Hydrochloride 0.4 milligrams in people with Ureterolithiasis and Ureteral Calculi, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 7 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: stopped early, as of the sponsor's last update on 31 Jan 2020. 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 Chile. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Problems with the number of participants). 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?
stone free rate (time frame: 30 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 31 Jan 2020.