Renal StoneNCT05725122
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
A study testing Extracorporeal shock wave lithotripsy and Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy. in people with Renal Stone, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Stone
- What is being tested?
- Extracorporeal shock wave lithotripsy and Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2018to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single upper ureteric stone
- size ranging from 6-15 mm
- stones history less than 6 months
Who cannot join
- Patients with urinary tract infection
- multiple ureteric stones,
- presence of a ureteric stricture distal to the stone,
- previous unsuccessful ESWL,
- concomitant use of calcium channel blockers or alpha-adrenergic antagonists
- patients with abnormal coagulation profile
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
services Institute of Medical Sciences
Lahore, Punjab Province
About this study
Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones
- Conditions
- Renal Stone
- Being tested
- Extracorporeal shock wave lithotripsy, Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave lithotripsyProcedure or surgery
Extracorporeal shock wave lithotripsy will given to the patients
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.Procedure or surgery
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients
| Study group | Role | What they receive |
|---|---|---|
| ESWL alone | Active comparator | Extracorporeal shock wave lithotripsy will be given to the patient Receives: Procedure: Extracorporeal shock wave lithotripsy |
| ESWL combined with tamsulosin therapy | Active comparator | Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient Receives: Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone clearance
Number of patients cleared from ureteric stones
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725122
- Sponsor's protocol ID
- S23
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
- ClinicalTrials.gov ID
- NCT05725122
- Acronym / sponsor ID
- S23
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Feb 2023 (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.
Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL alone | Active comparator | Procedure: Extracorporeal shock wave lithotripsyExtracorporeal shock wave lithotripsy will be given to the patient |
| ESWL combined with tamsulosin therapy | Active comparator | Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- single upper ureteric stone
- size ranging from 6-15 mm
- stones history less than 6 months
Key exclusion criteria (6 listed)
- Patients with urinary tract infection
- multiple ureteric stones,
- presence of a ureteric stricture distal to the stone,
- previous unsuccessful ESWL,
- concomitant use of calcium channel blockers or alpha-adrenergic antagonists
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 |
|---|---|---|
| Extracorporeal shock wave lithotripsyExtracorporeal shock wave lithotripsy will given to the patients | Procedure or surgery | ESWL alone |
| Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients | Procedure or surgery | ESWL combined with tamsulosin therapy |
Primary outcome
stone clearance
Time frame: 4 weeks
Number of patients cleared from ureteric stones
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 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Stone
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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 Extracorporeal shock wave lithotripsy and Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy. in people with Renal Stone, run by Services Hospital, Lahore at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 13 Feb 2023. 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 Pakistan. 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. 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 clearance (time frame: 4 weeks). 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 13 Feb 2023.