Lower Ureteric StonesDJNCT05823662
Double J Stenting and Sildosin After URSL for Lower Ureteric Stones
A study testing DJ stent and Silodosin in people with Lower Ureteric Stones and Ureteroscopic Lithotripsy, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this prospective comparative clinical study to compare DJ stenting and Sildosin after ureteroscopic lithotripsy for lower ureteric stones. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Ureteric Stones, Ureteroscopic Lithotripsy, DJ Stenting
- What is being tested?
- DJ stent and Silodosin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2022to 2 Mar 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 to 60 years,
- Diagnosed with lower ureteric stone and those patients willing to participate and follow up in the study.
Who cannot join
- Patients having a previous or present history of prostatic or bladder surgery, malignancy, neurological disorder, pelvic irradiation, and diabetes.
- Acute or chronic renal insufficiency, solitary kidney or congenital urinary abnormality, cardiac disease, postoperative residual stone fragments, multiple or bilateral ureteral stones, patients with bilateral stents or long-term stenting with frequent change of stents, history of interstitial cystitis, chronic cystitis or prostatitis.
- Medical treatment (α blockers, beta-blockers, calcium antagonists, 5 alfa reductase inhibitors, phosphodiesterase type 5 inhibitors, anticholinergics and cholinergic, nitrates).
- Pregnant and lactating women and patients not available for follow-up will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between DJ Stenting and Sildosin After Uretroscopic Lithotripsy for Lower Ureteric Stones
The aim of this prospective comparative clinical study to compare DJ stenting and Sildosin after ureteroscopic lithotripsy for lower ureteric stones.
Read the detailed description
Ureteric calculi are known to affect approximately 10 - 15% of the overall population. The incidence of urolithiasis is rising over time. Most of these stones are known to pass spontaneously with or without expulsive medical therapy. The expulsion of calculus depends on the following factors: the calculus size and the location in the ureter (Alelign and Petros, 2018). The calculi expulsion rates change depending on these factors, with the expulsion rate ranging from 40% to 98% for calculi less than 5 mm. The calculi, which measure 6 mm or more have a spontaneous expulsion rate ranging between 35% to 50%.
Semirigid ureteroscopy (URS) lithotripsy has been shown to have high success rates for treating distal ureteric stones in many studies. However, URS is associated with some drawbacks, which may be risky and sometimes problematic.
The use of Double J (DJ) stent after ureteroscopy helps in the passage of residual fragments and prevents pain caused due to mucosal edema and obstruction. However, many patients complain of stent-related discomfort in the postoperative period. There is an additional need for stent removal, which is another surgical procedure adding to the cost of treatment. Despite its usefulness, the morbidity associated with these stents has been considered a potential health problem. However, many patients complain of stent-related discomfort in the postoperative period. There is an additional need for stent removal, which is another surgical procedure adding to the cost of treatment.
Silodosin is a highly selective alpha-1 adrenergic receptor antagonist which is used in the treatment of lower urinary tract symptoms (LUTS). Alpha-1 adrenergic receptors are densely found in the smooth muscle cells of the lower urinary tract, and silodosin relaxes them and improves the stent-related symptoms (SRS), and various studies have also shown similar effects. It has documented its use in the therapy of ureteric calculus.
- Being tested
- DJ stent, Silodosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DJ stentProcedure or surgery
A 5 Fr DJ stent will be inserted and then removed after three weeks.
SilodosinDrug
Patients will be given one capsule of silodosin 8 mg at the night for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| DJ stent group | Experimental | A 5 Fr double J stent will be inserted and then removed after three weeks. Receives: Procedure: DJ stent |
| Silodosin group | Experimental | Patients will be given one capsule of silodosin 8 mg at the night for three weeks. Receives: Drug: Silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
Stone free rate 24 hours and stone free rate 73 hours Stone free rate 73 hours Stone free rate 24 hours Stone free rate 73 hours Stone free rate will be recorded
Measured: 3 weeks
Secondary outcomes (2)
Operative time
Operative time in minutes will be recorded
Measured: Intraoperatively
Comlications
Complications as fever, flank pain, Lower Urinary lower urinary tract Symptoms or hematuria
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start2 Mar 2022
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Ureteric StonesStudies of the same condition, open and under way.
- More trials run by Benha 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abou Elezz Abdel Fattah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823662
- Sponsor's protocol ID
- RC 6-2-2023
- Acronym
- DJ
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available under a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between DJ Stenting and Sildosin After Uretroscopic Lithotripsy for Lower Ureteric Stones
- ClinicalTrials.gov ID
- NCT05823662
- Acronym / sponsor ID
- DJ / RC 6-2-2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 21 Apr 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.
The aim of this prospective comparative clinical study to compare DJ stenting and Sildosin after ureteroscopic lithotripsy for lower ureteric stones.
Detailed description
Ureteric calculi are known to affect approximately 10 - 15% of the overall population. The incidence of urolithiasis is rising over time. Most of these stones are known to pass spontaneously with or without expulsive medical therapy. The expulsion of calculus depends on the following factors: the calculus size and the location in the ureter (Alelign and Petros, 2018). The calculi expulsion rates change depending on these factors, with the expulsion rate ranging from 40% to 98% for calculi less than 5 mm. The calculi, which measure 6 mm or more have a spontaneous expulsion rate ranging between 35% to 50%.
Semirigid ureteroscopy (URS) lithotripsy has been shown to have high success rates for treating distal ureteric stones in many studies. However, URS is associated with some drawbacks, which may be risky and sometimes problematic.
The use of Double J (DJ) stent after ureteroscopy helps in the passage of residual fragments and prevents pain caused due to mucosal edema and obstruction. However, many patients complain of stent-related discomfort in the postoperative period. There is an additional need for stent removal, which is another surgical procedure adding to the cost of treatment. Despite its usefulness, the morbidity associated with these stents has been considered a potential health problem. However, many patients complain of stent-related discomfort in the postoperative period. There is an additional need for stent removal, which is another surgical procedure adding to the cost of treatment.
Silodosin is a highly selective alpha-1 adrenergic receptor antagonist which is used in the treatment of lower urinary tract symptoms (LUTS). Alpha-1 adrenergic receptors are densely found in the smooth muscle cells of the lower urinary tract, and silodosin relaxes them and improves the stent-related symptoms (SRS), and various studies have also shown similar effects. It has documented its use in the therapy of ureteric calculus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DJ stent group | Experimental | Procedure: DJ stentA 5 Fr double J stent will be inserted and then removed after three weeks. |
| Silodosin group | Experimental | Drug: SilodosinPatients will be given one capsule of silodosin 8 mg at the night for three weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age >18 to 60 years,
- Diagnosed with lower ureteric stone and those patients willing to participate and follow up in the study.
Key exclusion criteria (4 listed)
- Patients having a previous or present history of prostatic or bladder surgery, malignancy, neurological disorder, pelvic irradiation, and diabetes.
- Acute or chronic renal insufficiency, solitary kidney or congenital urinary abnormality, cardiac disease, postoperative residual stone fragments, multiple or bilateral ureteral stones, patients with bilateral stents or long-term stenting with frequent change of stents, history of interstitial cystitis, chronic cystitis or prostatitis.
- Medical treatment (α blockers, beta-blockers, calcium antagonists, 5 alfa reductase inhibitors, phosphodiesterase type 5 inhibitors, anticholinergics and cholinergic, nitrates).
- Pregnant and lactating women and patients not available for follow-up will be excluded from this 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 |
|---|---|---|
| DJ stentA 5 Fr DJ stent will be inserted and then removed after three weeks. | Procedure or surgery | DJ stent group |
| SilodosinPatients will be given one capsule of silodosin 8 mg at the night for three weeks. | Drug | Silodosin group |
Primary outcome
Stone-free rate
Time frame: 3 weeks
Stone free rate 24 hours and stone free rate 73 hours Stone free rate 73 hours Stone free rate 24 hours Stone free rate 73 hours Stone free rate will be recorded
2 secondary outcomes
Operative time
Time frame: Intraoperatively
Comlications
Time frame: 24 hours 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 24 Apr 2023.
- Individual participant dataSharing planned: Yes. The study will be available under a reasonable request from the corresponding author.
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 DJ stent and Silodosin in people with Lower Ureteric Stones and Ureteroscopic Lithotripsy, run by Benha 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 4 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 24 Apr 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 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. 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 (time frame: 3 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 24 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.