Stones, KidneyNCT06830577
Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure
A study testing Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy, Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy and Aminophylline instillation and Ureteral dilators together in people with Stones, Kidney and Ureteric Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stones, Kidney, Ureteric Injury
- What is being tested?
- Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy, Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy and Aminophylline instillation and Ureteral dilators together
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Upper ureteric stones or renal stones < 2 cm
Who cannot join
- Ureteric strictures.
- anatomic renal disorders
- functional renal disorders
- Urinary tract infection.
- Coagulopathy and uncorrected bleeding disorders.
- Prior DJ stenting
- any contraindication for aminophylline use: (hypersensitivity to theophylline, ethylenediamine, or any component of the drug formulation, pregnancy or lactation, active peptic ulcer, presence of cardiologic diseases, presence of neurologic diseases, presence of renal impairment and presence of hepatic dysfunction)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, Abassia, 11517
Ali Khaled Mohammed Ali M. Dr. Ali Khaled, MSc., 201099978174, ali.khaled94@gmail.com
Younan R. Lecturer Dr. Younan Ramsis Samir, PhD., 201255511
About this study
Official title: Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study
in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.
Read the detailed description
Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries.
patients will be divided into 3 groups:
- Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline
- Group B (Ureteral Dilator Group): Traditional ureteral dilators
- Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)
- Conditions
- Stones, Kidney, Ureteric Injury
- Being tested
- Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy, Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy, Aminophylline instillation and Ureteral dilators together
- Keywords
- Aminophylline, Ureteric access sheath, ureteric injury, Flexible Uretroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopyDrug
Also called Intraureteric Aminophylline instillation prior to access sheath insertion
Intraureteric aminophylline installation prior to ureteric dilatation
Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopyDevice
Also called ureteric teflon dilators prior to access sheath insertion
traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
Aminophylline instillation and Ureteral dilators togetherOther
Also called combination of aminophylline instillation and ureteric teflon dilators prior to access sheath insertion
Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath
| Study group | Role | What they receive |
|---|---|---|
| Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline | Experimental | a ureteric catheter 6 Fr will be used for instillation of normal saline supplemented with aminophylline 250 mg/10 mL at three points (Pelvi-ureteric junction, upper sacroiliac joint level and proximal to uretero-vesical junction by 5 cm) then wait for 5 minutes Receives: Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy |
| Group B: Ureteral Dilator Group: Traditional ureteral dilators | Active comparator | traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr Receives: Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy |
| Group C: Combination Group: Aminophylline instillation and Ureteral dilators | Other | Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) Receives: Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy; Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy; Other: Aminophylline instillation and Ureteral dilators together |
What is being measured
The primary outcome is the main question the study is designed to answer.
The successful placement of ureteric access sheath
we will assess the successful placement of ureteric access sheath in patients (that the access sheath is passed on the guide wire till the pelviureteric junction portion of the ureter after the usage of intraureteric aminophylline or teflon dilators or the usage of both.
Measured: intraoperative application of the access sheath
Secondary outcomes (1)
successful stone clearance
the stone free rate following intervention
Measured: 3 weeks postoperative follow up with urinary tract multislice CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stones, KidneyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Younan Samir, PhD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830577
- Sponsor's protocol ID
- Intraureteric aminophylline
- Status last verified
- Jun 2025
- First submitted
- 3 Feb 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shabayek M, Osman T, Wahb M, Elmoazen M, Osman D, Saafan A. Intravesical aminophylline instillation as an alternative for balloon dilatation prior to semi-rigid ureteroscopic management of distal ureteral stones. World J Urol. 2022 Jul;40(7):1805-1811. doi: 10.1007/s00345-022-04039-7. Epub 2022 May 26.
PubMed 35618855
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06830577
- Acronym / sponsor ID
- Intraureteric aminophylline
- Conditions
- Stones, Kidney, Ureteric Injury
- Keywords
- Aminophylline, Ureteric access sheath, ureteric injury, Flexible Uretroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.
Detailed description
Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries.
patients will be divided into 3 groups:
- Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline
- Group B (Ureteral Dilator Group): Traditional ureteral dilators
- Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline | Experimental | Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopya ureteric catheter 6 Fr will be used for instillation of normal saline supplemented with aminophylline 250 mg/10 mL at three points (Pelvi-ureteric junction, upper sacroiliac joint level and proximal to uretero-vesical junction by 5 cm) then wait for 5 minutes |
| Group B: Ureteral Dilator Group: Traditional ureteral dilators | Active comparator | Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopytraditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr |
| Group C: Combination Group: Aminophylline instillation and Ureteral dilators | Other | Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy, Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy, Other: Aminophylline instillation and Ureteral dilators togetherAminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Upper ureteric stones or renal stones < 2 cm
Key exclusion criteria (7 listed)
- Ureteric strictures.
- anatomic renal disorders
- functional renal disorders
- Urinary tract infection.
- Coagulopathy and uncorrected bleeding disorders.
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 |
|---|---|---|
| Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopyAlso: Intraureteric Aminophylline instillation prior to access sheath insertionIntraureteric aminophylline installation prior to ureteric dilatation | Drug | Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline, Group C: Combination Group: Aminophylline instillation and Ureteral dilators |
| Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopyAlso: ureteric teflon dilators prior to access sheath insertiontraditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr | Device | Group B: Ureteral Dilator Group: Traditional ureteral dilators, Group C: Combination Group: Aminophylline instillation and Ureteral dilators |
| Aminophylline instillation and Ureteral dilators togetherAlso: combination of aminophylline instillation and ureteric teflon dilators prior to access sheath insertionAminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath | Other | Group C: Combination Group: Aminophylline instillation and Ureteral dilators |
Primary outcome
The successful placement of ureteric access sheath
Time frame: intraoperative application of the access sheath
we will assess the successful placement of ureteric access sheath in patients (that the access sheath is passed on the guide wire till the pelviureteric junction portion of the ureter after the usage of intraureteric aminophylline or teflon dilators or the usage of both.
1 secondary outcome
successful stone clearance
Time frame: 3 weeks postoperative follow up with urinary tract multislice CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 35618855Shabayek M, Osman T, Wahb M, Elmoazen M, Osman D, Saafan A. Intravesical aminophylline instillation as an alternative for balloon dilatation prior to semi-rigid ureteroscopic management of distal ureteral stones. World J Urol. 2022 Jul;40(7):1805-1811. doi: 10.1007/s00345-022-04039-7. Epub 2022 May 26.
- Individual participant dataSharing planned: No
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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.
Younan Samir, PhD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy, Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy and Aminophylline instillation and Ureteral dilators together in people with Stones, Kidney and Ureteric Injury, 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 7 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc. (+201099978174, ali.khaled94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The successful placement of ureteric access sheath (time frame: intraoperative application of the access sheath). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830577, which also lists 1 linked publication.
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 12 Jun 2025.