Ureteric StoneEarly Phase 1NCT03274700
The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms
A Early Phase 1 study testing Tamsulosin. in people with Ureteric Stone, run by Assiut University.
Trial summary
To estimate the efficacy of tamsulosin in: A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal). B - Pain relief and hyronephrosis improvement (secondary goal). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteric Stone
- What is being tested?
- Tamsulosin.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to Oct 2018
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lower ureteric stones from(10-15) mm diameters.
- Age group equal or more than 18 years.
- Normal renal function.
Who cannot join
- Lower ureteric stones less than 10mm and more than 15 mm diameters.
- Age group less than 18 years.
- Associated ureteric strictures.
- Febrile urinary tract infections.
- Severe hydronephrosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms: A Prospective Randomized Study
To estimate the efficacy of tamsulosin in:
A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).
B - Pain relief and hyronephrosis improvement (secondary goal).
Read the detailed description
Urolithiasis affects 4-15% of world population and the incidence of this disease is increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of these ureteral stones are found in the distal part of the ureters . The goal of treatment of patients suffering from ureteral calculi is to achieve complete stone clearance with minimal morbidity .
Ureteral calculi of any size may be associated with renal obstruction and care must be taken to prevent irreversible damage to kidney, whether patient selects expectant or active treatment . An expectant treatment or watchful waiting approach may be expected to produce spontaneous stone expulsion up to 50% of cases but some complications such as urinary infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative approach proves to be unsuccessful, interventional treatment becomes necessary. After a period of conservative treatment, however, intervention is often inefficient or has a higher risk for complications due to stone impaction and the associated inflammatory reaction of the ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but these procedures are not risk free and they require some experience and not cost effective .
The therapeutic potential of α-blockers for ureteral stone disease has been investigated, prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus on tamsulosin because it is the most frequently studied α-blocker, recommended in urology treatment guidelines, and, in our experience, the most common medical expulsive therapy used by emergency physicians .
The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral stones from 10-15 mm diameter in a randomised, placebo-controlled setting.
- Conditions
- Ureteric Stone
- Being tested
- Tamsulosin., Placebo.
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin.Drug
Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
Placebo.Drug
Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients receive tamsulosin | Active comparator | Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones. Receives: Drug: Tamsulosin. |
| Patients receive placebo. | Placebo comparator | Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following:
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones. Receives: Drug: Placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.
Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ureteric StoneStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud eldardery, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274700
- Sponsor's protocol ID
- tamsulosin in ureteric stones
- Status last verified
- Aug 2017
- First submitted
- 27 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pearle MS. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. Int Braz J Urol. 2004 Nov-Dec;30(6):546-547. No abstract available.
PubMed 15748331Wang RC, Smith-Bindman R, Whitaker E, Neilson J, Allen IE, Stoller ML, Fahimi J. Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis. Ann Emerg Med. 2017 Mar;69(3):353-361.e3. doi: 10.1016/j.annemergmed.2016.06.044. Epub 2016 Sep 8.
PubMed 27616037Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H. The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones. J Urol. 2005 Jun;173(6):2010-2. doi: 10.1097/01.ju.0000158453.60029.0a.
PubMed 15879806
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03274700
- Acronym / sponsor ID
- tamsulosin in ureteric stones
- Conditions
- Ureteric Stone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 7 Sep 2017 (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.
To estimate the efficacy of tamsulosin in:
A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).
B - Pain relief and hyronephrosis improvement (secondary goal).
Detailed description
Urolithiasis affects 4-15% of world population and the incidence of this disease is increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of these ureteral stones are found in the distal part of the ureters . The goal of treatment of patients suffering from ureteral calculi is to achieve complete stone clearance with minimal morbidity .
Ureteral calculi of any size may be associated with renal obstruction and care must be taken to prevent irreversible damage to kidney, whether patient selects expectant or active treatment . An expectant treatment or watchful waiting approach may be expected to produce spontaneous stone expulsion up to 50% of cases but some complications such as urinary infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative approach proves to be unsuccessful, interventional treatment becomes necessary. After a period of conservative treatment, however, intervention is often inefficient or has a higher risk for complications due to stone impaction and the associated inflammatory reaction of the ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but these procedures are not risk free and they require some experience and not cost effective .
The therapeutic potential of α-blockers for ureteral stone disease has been investigated, prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus on tamsulosin because it is the most frequently studied α-blocker, recommended in urology treatment guidelines, and, in our experience, the most common medical expulsive therapy used by emergency physicians .
The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral stones from 10-15 mm diameter in a randomised, placebo-controlled setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients receive tamsulosin | Active comparator | Drug: Tamsulosin.Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones. |
| Patients receive placebo. | Placebo comparator | Drug: Placebo.Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lower ureteric stones from(10-15) mm diameters.
- Age group equal or more than 18 years.
- Normal renal function.
Key exclusion criteria (5 listed)
- Lower ureteric stones less than 10mm and more than 15 mm diameters.
- Age group less than 18 years.
- Associated ureteric strictures.
- Febrile urinary tract infections.
- Severe hydronephrosis.
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.Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration. | Drug | Group 1: Patients receive tamsulosin |
| Placebo.Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration. | Drug | Patients receive placebo. |
Primary outcome
Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.
Time frame: 1year
Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Background: PubMed 15748331Pearle MS. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. Int Braz J Urol. 2004 Nov-Dec;30(6):546-547. No abstract available.
- Background: PubMed 27616037Wang RC, Smith-Bindman R, Whitaker E, Neilson J, Allen IE, Stoller ML, Fahimi J. Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis. Ann Emerg Med. 2017 Mar;69(3):353-361.e3. doi: 10.1016/j.annemergmed.2016.06.044. Epub 2016 Sep 8.
- Background: PubMed 15879806Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H. The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones. J Urol. 2005 Jun;173(6):2010-2. doi: 10.1097/01.ju.0000158453.60029.0a.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tamsulosin. in people with Ureteric Stone, run by Assiut University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact mahmoud eldardery, resident (01008763519, meldardery91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274700, which also lists 3 linked publications.
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 7 Sep 2017.