Non-stented Ureteroscopic Laser Lithotripsy for Ureteric StonesPhase 3NCT04557202
Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones: A Randomized Controlled Trial
A Phase 3 study testing Tamsulosin Oral Capsule in people with Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones, run by Ain Shams University at 1 site in Egypt.
Trial summary
To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
- What is being tested?
- Tamsulosin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Dec 2018
- Phase
- Phase 3
- 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 single lower ureteric stones of size range between 0.5 and 2 cm
Who cannot join
- Patients under the age of 18, pregnant women, or those with urinary tract infections, uncorrected bleeding disorders or coagulopathies, bilateral ureteric stones, single kidney, ureteral stricture, multiple ipsilateral ureteric stones were excluded from our study. Also, any patients who required ureteric stenting were excluded from our study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Read the detailed description
Objective: To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Patients and Methods: A randomized control trial was conducted at two high volume urological centers from September 2017 to December 2018. We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
- Being tested
- Tamsulosin Oral Capsule, Placebo
- Keywords
- Uretroscopic lithotripsy, non-stented, alpha1-blocker, LUTS, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Oral CapsuleDrug
To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
PlaceboDrug
Placebo - control group
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively Receives: Drug: Tamsulosin Oral Capsule |
| Group B | Placebo comparator | 62 patients who underwent non-stented ureteroscopy and laser and received placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for dilatation
( to evaluate whether the ureteroscope will pass easily through the ureter if not , serial ureteric dilatation will be done and documented ) it is a yes or no evaluation
Measured: intraoperative assessment
Secondary outcomes (6)
Time of operation (min)
duration of the procedure in minutes
Measured: intraoperative assessment
Lower urinary tract symptoms "LUTs"
(frequency, urgency and dysuria) (Yes/NO)
Measured: early postoperative period ( 2 weeks)
Need for analgesia
need for analgesics for postoperative pain according to the numeric rating scale (yes/no)
Measured: first day postoperative
Gross Hematuria
post operative hematuria (present or not )
Measured: first day postoperative
Fever
elevated body temperature post operative in degree Celsius
Measured: early postoperative (2 weeks)
hospital stay
duration in hours
Measured: from few hours up to 2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Sep 2017
- Primary completion1 Aug 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-stented Ureteroscopic Laser Lithotripsy for Ureteric StonesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557202
- Sponsor's protocol ID
- fwa00001989
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
- ClinicalTrials.gov ID
- NCT04557202
- Acronym / sponsor ID
- fwa00001989
- Keywords
- Uretroscopic lithotripsy, non-stented, alpha1-blocker, LUTS, postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 21 Sep 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.
To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Detailed description
Objective: To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Patients and Methods: A randomized control trial was conducted at two high volume urological centers from September 2017 to December 2018. We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Tamsulosin Oral CapsuleGroup A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively |
| Group B | Placebo comparator | Drug: Placebo62 patients who underwent non-stented ureteroscopy and laser and received placebo. |
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 single lower ureteric stones of size range between 0.5 and 2 cm
Key exclusion criteria (1 listed)
- Patients under the age of 18, pregnant women, or those with urinary tract infections, uncorrected bleeding disorders or coagulopathies, bilateral ureteric stones, single kidney, ureteral stricture, multiple ipsilateral ureteric stones were excluded from our study. Also, any patients who required ureteric stenting were excluded from our study.
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 Oral CapsuleTo assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones. | Drug | Group A |
| PlaceboPlacebo - control group | Drug | Group B |
Primary outcome
Need for dilatation
Time frame: intraoperative assessment
( to evaluate whether the ureteroscope will pass easily through the ureter if not , serial ureteric dilatation will be done and documented ) it is a yes or no evaluation
6 secondary outcomes
Time of operation (min)
Time frame: intraoperative assessment
Lower urinary tract symptoms "LUTs"
Time frame: early postoperative period ( 2 weeks)
Need for analgesia
Time frame: first day postoperative
Gross Hematuria
Time frame: first day postoperative
Fever
Time frame: early postoperative (2 weeks)
hospital stay
Time frame: from few hours up to 2 days postoperative
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 21 Sep 2020.
- Individual participant dataSharing planned: Undecided
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 Phase 3 study testing Tamsulosin Oral Capsule in people with Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones, run by Ain Shams 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 1 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 21 Sep 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Need for dilatation (time frame: intraoperative assessment). 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 21 Sep 2020.