Urologic DiseasesNCT05032287
Medical Expulsive Therapy Post-SWL For Renal Stones
A study testing Tamsulosin in people with Urologic Diseases and Urolithiasis, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Urolithiasis, Stone, Kidney
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal stone ≤ 20 mm.
- Lower calyceal stone ≤ 15 mm
Who cannot join
- Women with known or suspected pregnancy or breastfeeding.
- History of alpa-blockers (more than 7 days prior to study participation)
- History of ureteral stricture
- Multiple (that is more than 2) stones
- Stone in solitary kidney (either anatomically or functionally).
- Presence of urinary sepsis.
- Estimated glomerular filtration rate < 30 ml/min
- Contraindication or allergy to tamsulosin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial
To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm
- Conditions
- Urologic Diseases, Urolithiasis, Stone, Kidney
- Being tested
- Tamsulosin, Placebo
- Medical subject headings
- Urologic Diseases, Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Tamsulosin 0.4 mg once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin | Active comparator | tamsulosin 0.4 mg once daily Receives: Drug: Tamsulosin |
| Placeb | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate defined as patient free of any stone residual
assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032287
- Sponsor's protocol ID
- MET SWL
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial
- ClinicalTrials.gov ID
- NCT05032287
- Acronym / sponsor ID
- MET SWL
- Conditions
- Urologic Diseases, Urolithiasis, Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 2 Sep 2021 (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 evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamsulosin | Active comparator | Drug: Tamsulosintamsulosin 0.4 mg once daily |
| Placeb | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Renal stone ≤ 20 mm.
- Lower calyceal stone ≤ 15 mm
Key exclusion criteria (8 listed)
- Women with known or suspected pregnancy or breastfeeding.
- History of alpa-blockers (more than 7 days prior to study participation)
- History of ureteral stricture
- Multiple (that is more than 2) stones
- Stone in solitary kidney (either anatomically or functionally).
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 |
|---|---|---|
| TamsulosinTamsulosin 0.4 mg once daily | Drug | tamsulosin |
| PlaceboPlacebo once daily | Drug | Placeb |
Primary outcome
Stone free rate defined as patient free of any stone residual
Time frame: at 3 months
assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin in people with Urologic Diseases and Urolithiasis, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 defined as patient free of any stone residual (time frame: at 3 months). 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 2 Sep 2021.