Ureteric Stone of Lower Third of UreterPhase 4NCT05977647
Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi
A Phase 4 study testing Tamsulosin Oral Capsule in people with Ureteric Stone of Lower Third of Ureter, run by Getz Pharma at 1 site in Pakistan.
Trial summary
As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. There is high evidence of the therapeutic benefit of α-blockers in the treatment of Distal ureteric stone (DUS); also endorsed by international guidelines. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteric Stone of Lower Third of Ureter
- What is being tested?
- Tamsulosin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2024to 30 Jun 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults male and female aged 18 to 70 years
- Patients who give informed consent
- Stone located in the distal 1/3rd of ureter (Single, unilateral and radiopaque ureteral calculus 5 to 10 mm visible on the CT-KUB± X-ray KUB within the ureter
- Serum creatinine level within the normal range (adult men, 0.74 to 1.35 mg/dL \& 0.59 to 1.04 mg/dL)
- Ability to tolerate oral fluids and oral pain medication
Who cannot join
- Patients already taking an alpha-adrenergic antagonist medication for 4 weeks
- Evidence of any other renal stone simultaneously present or at any location
- Hydronephrosis Grade 3 (Moderate) \& Grade 4 (Severe) Patients with eGFR <60 ml/min/1.73m2
- Signs of infection including temperature >38ºC or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count >5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of >100,000 CFU)
- Patients with chronic pain already undergoing treatment with narcotic medications or drug abusers
- Pregnant or lactating women
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- Patient suffering from urinary tract infection, ureteral surgery, and existing DJ stents.
- Clinical jaundice
- Any forms of anatomical obstructions in the urinary tract
- The previously suffering from postural hypotension
- Any other disease jeopardizing participation in trial and could lead to increase patient health risks
- History of allergic reactions with the study drugs (Silodosin or Tamsulosin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Silodosin Versus Tamsulosin on Passage of Acutely Obstructing Ureteral Calculi (History of Last 4 Weeks) in Medical Expulsive Therapy
As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. There is high evidence of the therapeutic benefit of α-blockers in the treatment of Distal ureteric stone (DUS); also endorsed by international guidelines.
However, limited data is available worldwide, on the effect of silodosin to treat DUS. A multi-center study is needed to confirm the efficacy and safety of therapy.
Read the detailed description
A kidney stone is a crystal formed inside the kidney. It is one of the commonest conditions of kidney disease affecting 12% of the world's population. Out of 12% Ureteric stones, around 20% represent cases of urolithiasis, of which 70% are situated in the lower third of the ureter and are termed as 'Distal Ureteric Stones' (DUS). Kidney stone aggravates the risk of end-stage kidney disease and increases the risk of multiple complications. including chronic kidney disease hypertension, diabetes, and cardiovascular diseases. The commonest type of kidney stone is calcium oxalate, which is present in around 70 to 80% of the total reported cases of kidney stones.
There are multiple approaches to the management of ureteric stones, which has evolved over the last 20 years, specifically due to advancements in technology, use of ureteroscopy and shockwave lithotripsy (SWL) as minimally invasive treatment options. However, these interventions are quite expensive and may lead to multiple complications. According to the complication rate of minimally invasive interventions is 2.5%.
As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. As observed through two meta-analyses there is high evidence of the therapeutic benefit of α-blockers in the treatment of DUS seen to be 52% and 44% higher than those patients who have not received any treatment.
There is an endorsement of the use of a-blockers as a management option for ureteric stones by the American Urology Association (AUA) and the European Association of Urology. The α1A- adrenoceptors have proven to play an important effect in intervening contraction of the human ureter, induced by phenylephrine. Silodosin (selective α1-adrenoceptor blocker) in the human ureter was found more efficacious than Tamsulosin (1D-adrenoceptor blocker) in non-adrenaline-induced contractions.
However, limited data is available worldwide, on the effect of silodosin to treat DUS. To the best of our knowledge, there has been no study done on the use of silodosin as MET for DUS in the context of Pakistan. Therefore, this study will be able to provide meaningful data to find the efficacy and safety of silodosin in comparison to Tamsulosin as MET in ureteric stone.
- Conditions
- Ureteric Stone of Lower Third of Ureter
- Being tested
- Tamsulosin Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Oral CapsuleDrug
Also called silodosin Oral Capsule
Patient will be enrolled in one of study arm through randomization.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | Patients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on tamsulosin 0.4 mg once daily, therapy will be given for a maximum of 4 weeks. Receives: Drug: Tamsulosin Oral Capsule |
| Silodosin | Active comparator | Patients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on Silodosin 8 mg once daily. Therapy will be given for a maximum of 4 weeks. Receives: Drug: Tamsulosin Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of stone expulsion
The primary outcome measure will be the passage of stone expulsion self-reported definitive passage of calculus or the first day of pain-free to 48 hours period with calculus absent of X - ray KUB.
Measured: 4 weeks
Secondary outcomes (6)
Time in days to stone expulsion
Time in days to stone expulsion: Self-reported definitive passage of calculus or the first day of pain-free to 48 hours period with calculus absent of X - ray.
Measured: 4 weeks
Frequency of pain reported by patients
Patient will mark the number of episodes of pain in 24 hours on daily basis in patient dairy..
Measured: 4 weeks
Change in intensity of pain
Patient dairy will be provided to all the patients. Which will have pain log scale. They will self-report the intensity of pain (highest intensity) in 24 hours on daily basis. The pain scale ranges are mentioned below.
- 0 means no pain
- 1 to 2 means mild pain
- 2 to 4 means moderate pain
- 4 to 6 means severe pain
- 6 to 8 means very severe pain
- 8 to 10 means worst pain ever
Measured: 4 weeks
Usage of analgesics
The subject will be given a standardized pain medication (diclofenac sodium) prescription at their initial visit and will be asked to keep track of how much pain medication they used each day in patient's dairy. This information will be collected at every week on follow up visits.
Measured: 4 weeks
Frequency of ER visits
Patient will report if he/she had visited ER in last 24 hours on daily basis in patient's dairy along with the medication prescribed in ER.
Measured: 4 weeks
Frequency of adverse events (Postural hypotension, retrograde ejaculation, etc.)
Patient will be briefed about the known adverse events of study drugs. If any side effects is observed by the patient will be reported in patient dairy.
If any unknown side effects happen that will also be reported in patient diary.
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 posted4 Aug 2023
- Study start1 Sep 2024
- Primary completion30 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric Stone of Lower Third of UreterStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two groups. 1. A permuted block randomization technique will be used 2. A block represents a separate center/site of enrollment. 3. There will be 19 recruitment centers 4. Each center will enroll total 20-25 subjects
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salman El Khalid, MBBS, Principal investigator, The Kidney Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977647
- Sponsor's protocol ID
- GTZ-MSE-001-23
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Silodosin Versus Tamsulosin on Passage of Acutely Obstructing Ureteral Calculi (History of Last 4 Weeks) in Medical Expulsive Therapy
- ClinicalTrials.gov ID
- NCT05977647
- Acronym / sponsor ID
- GTZ-MSE-001-23
- Conditions
- Ureteric Stone of Lower Third of Ureter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 4 Aug 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.
As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. There is high evidence of the therapeutic benefit of α-blockers in the treatment of Distal ureteric stone (DUS); also endorsed by international guidelines.
However, limited data is available worldwide, on the effect of silodosin to treat DUS. A multi-center study is needed to confirm the efficacy and safety of therapy.
Detailed description
A kidney stone is a crystal formed inside the kidney. It is one of the commonest conditions of kidney disease affecting 12% of the world's population. Out of 12% Ureteric stones, around 20% represent cases of urolithiasis, of which 70% are situated in the lower third of the ureter and are termed as 'Distal Ureteric Stones' (DUS). Kidney stone aggravates the risk of end-stage kidney disease and increases the risk of multiple complications. including chronic kidney disease hypertension, diabetes, and cardiovascular diseases. The commonest type of kidney stone is calcium oxalate, which is present in around 70 to 80% of the total reported cases of kidney stones.
There are multiple approaches to the management of ureteric stones, which has evolved over the last 20 years, specifically due to advancements in technology, use of ureteroscopy and shockwave lithotripsy (SWL) as minimally invasive treatment options. However, these interventions are quite expensive and may lead to multiple complications. According to the complication rate of minimally invasive interventions is 2.5%.
As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. As observed through two meta-analyses there is high evidence of the therapeutic benefit of α-blockers in the treatment of DUS seen to be 52% and 44% higher than those patients who have not received any treatment.
There is an endorsement of the use of a-blockers as a management option for ureteric stones by the American Urology Association (AUA) and the European Association of Urology. The α1A- adrenoceptors have proven to play an important effect in intervening contraction of the human ureter, induced by phenylephrine. Silodosin (selective α1-adrenoceptor blocker) in the human ureter was found more efficacious than Tamsulosin (1D-adrenoceptor blocker) in non-adrenaline-induced contractions.
However, limited data is available worldwide, on the effect of silodosin to treat DUS. To the best of our knowledge, there has been no study done on the use of silodosin as MET for DUS in the context of Pakistan. Therefore, this study will be able to provide meaningful data to find the efficacy and safety of silodosin in comparison to Tamsulosin as MET in ureteric stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two groups. 1. A permuted block randomization technique will be used 2. A block represents a separate center/site of enrollment. 3. There will be 19 recruitment centers 4. Each center will enroll total 20-25 subjects
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: Tamsulosin Oral CapsulePatients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on tamsulosin 0.4 mg once daily, therapy will be given for a maximum of 4 weeks. |
| Silodosin | Active comparator | Drug: Tamsulosin Oral CapsulePatients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on Silodosin 8 mg once daily. Therapy will be given for a maximum of 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults male and female aged 18 to 70 years
- Patients who give informed consent
- Stone located in the distal 1/3rd of ureter (Single, unilateral and radiopaque ureteral calculus 5 to 10 mm visible on the CT-KUB± X-ray KUB within the ureter
- Serum creatinine level within the normal range (adult men, 0.74 to 1.35 mg/dL \& 0.59 to 1.04 mg/dL)
- Ability to tolerate oral fluids and oral pain medication
Key exclusion criteria (12 listed)
- Patients already taking an alpha-adrenergic antagonist medication for 4 weeks
- Evidence of any other renal stone simultaneously present or at any location
- Hydronephrosis Grade 3 (Moderate) \& Grade 4 (Severe) Patients with eGFR <60 ml/min/1.73m2
- Signs of infection including temperature >38ºC or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count >5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of >100,000 CFU)
- Patients with chronic pain already undergoing treatment with narcotic medications or drug abusers
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 CapsuleAlso: silodosin Oral CapsulePatient will be enrolled in one of study arm through randomization. | Drug | Silodosin, Tamsulosin |
Primary outcome
% of stone expulsion
Time frame: 4 weeks
The primary outcome measure will be the passage of stone expulsion self-reported definitive passage of calculus or the first day of pain-free to 48 hours period with calculus absent of X - ray KUB.
6 secondary outcomes
Time in days to stone expulsion
Time frame: 4 weeks
Frequency of pain reported by patients
Time frame: 4 weeks
Change in intensity of pain
Time frame: 4 weeks
Usage of analgesics
Time frame: 4 weeks
Frequency of ER visits
Time frame: 4 weeks
Frequency of adverse events (Postural hypotension, retrograde ejaculation, etc.)
Time frame: 4 weeks
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 20 Aug 2025.
- Individual participant dataSharing planned: No
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.
Salman El Khalid, MBBS principal investigator
The Kidney Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin Oral Capsule in people with Ureteric Stone of Lower Third of Ureter, run by Getz Pharma 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 5 inclusion and 12 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 20 Aug 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
% of stone expulsion (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 20 Aug 2025.