Ureter StoneNCT04602403
Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
A study testing rigid ureteroscopy in people with Ureter Stone, run by Assiut University at 1 site in Egypt.
Trial summary
Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi. Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ureter Stone
- What is being tested?
- rigid ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 15 Oct 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower ureteral stone.
- Age: 18 - 75 years.
- normal renal function.
- single sided ureteral stone with normal other kideny.
- sign the informed consent.
- Be willing/able to adhere to follow up visits.
Who cannot join
- Upper and middle ureteral stones.
- renal impairment.
- Age < 18 years or 75 < years.
- female who were pregnant
- bilateral ureteric stone or solitary kidney.
- urinary tract infection need drainage.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahmoud Ahmed Gaber
Asyut, Asyut Governorate, 71511
mahmoud a gaber, ph, +201129248656, aboshika52@gmail.com
About this study
Official title: Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study
Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.
Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.
Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.
Read the detailed description
Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.
- Conditions
- Ureter Stone
- Being tested
- rigid ureteroscopy
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rigid ureteroscopyProcedure or surgery
Also called endoscopic treatment of ureteric stone
endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | people who given placebo to become agroup of comparison with the other group Receives: Procedure: rigid ureteroscopy |
| tamsulosin group | Active comparator | people who given tamsulosin to know the effect on ureteroscopy and compare with the control group Receives: Procedure: rigid ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients develop spontaneous expulsion of stone
the stone spontaneously expelled without intervension
Measured: up to 3 weeks pre operative
Number of patients showing dilated ureteric orifice
during ureteroscopy easy introduction in the ureter
Measured: intraoperative
Number of patients need dilatation below stone
difficult introduce the ureteroscope and reach the stone
Measured: intraoperative
Number of patients need dormia extraction or forceps without disintegration
that is due to dilated ureter so easy remove the stone
Measured: intraoperative
Time of operation from introduction of ureteroscope until stone extraction
to know how easy introduction and expulsion of the ureteroscope
Measured: intraoperative
Secondary outcomes (4)
Rate of patients developed side effect from tamsulosin
any side effect from alpha blocker
Measured: up to 3 weeks pre operative
Rate of patients developed complication
any compliction during ureteroscopy such as perforation
Measured: intraoperative
Number of patients show failure of ureteroscopy
failed introduction or extraction of stone
Measured: intraoperative
Number of patients show residual stone post ureteroscopy
difficulty in expulsion of all stones
Measured: postoperative 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start15 Oct 2020
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
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 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Gaber, Assiut University
- Investigators
- ahmed m abdel hamed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602403
- Sponsor's protocol ID
- tamsulosin and uretroscopy
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT04602403
- Acronym / sponsor ID
- tamsulosin and uretroscopy
- Conditions
- Ureter Stone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 26 Oct 2020 (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.
Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.
Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.
Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.
Detailed description
Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Procedure: rigid ureteroscopypeople who given placebo to become agroup of comparison with the other group |
| tamsulosin group | Active comparator | Procedure: rigid ureteroscopypeople who given tamsulosin to know the effect on ureteroscopy and compare with the control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lower ureteral stone.
- Age: 18 - 75 years.
- normal renal function.
- single sided ureteral stone with normal other kideny.
- sign the informed consent.
Key exclusion criteria (6 listed)
- Upper and middle ureteral stones.
- renal impairment.
- Age < 18 years or 75 < years.
- female who were pregnant
- bilateral ureteric stone or solitary kidney.
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 |
|---|---|---|
| rigid ureteroscopyAlso: endoscopic treatment of ureteric stoneendoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser | Procedure or surgery | placebo group, tamsulosin group |
Primary outcome
Rate of patients develop spontaneous expulsion of stone
Time frame: up to 3 weeks pre operative
the stone spontaneously expelled without intervension
Number of patients showing dilated ureteric orifice
Time frame: intraoperative
during ureteroscopy easy introduction in the ureter
Number of patients need dilatation below stone
Time frame: intraoperative
difficult introduce the ureteroscope and reach the stone
Number of patients need dormia extraction or forceps without disintegration
Time frame: intraoperative
that is due to dilated ureter so easy remove the stone
Time of operation from introduction of ureteroscope until stone extraction
Time frame: intraoperative
to know how easy introduction and expulsion of the ureteroscope
4 secondary outcomes
Rate of patients developed side effect from tamsulosin
Time frame: up to 3 weeks pre operative
Rate of patients developed complication
Time frame: intraoperative
Number of patients show failure of ureteroscopy
Time frame: intraoperative
Number of patients show residual stone post ureteroscopy
Time frame: postoperative 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
ahmed m abdel hamed study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rigid ureteroscopy in people with Ureter Stone, run by Assiut 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 6 inclusion and 6 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 26 Oct 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 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. 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.
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 a gaber (+201129248656, aboshika52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients develop spontaneous expulsion of stone (time frame: up to 3 weeks pre operative). The study lists 5 primary outcomes in all. 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 26 Oct 2020.