UrolithiasisNCT07868874
Comparison of Two Versus Four Weeks of Ureteral Stenting Prior to Ureteroscopy After Failed Primary Ureteral Access
A study testing Preoperative DJ Ureteral Stenting in people with Urolithiasis, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial summary
This study proposes a non-randomized controlled trial comparing 2 weeks versus 4 weeks of DJ ureteral stenting in patients whose primary ureteral access failed during an initial attempt at FURS. The purpose is to determine whether a longer stenting period improves subsequent ureteral access. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Preoperative DJ Ureteral Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to 31 Mar 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years of either gender presenting with renal and/or upper ureteric calculi ≤20 mm requiring flexible ureteroscopy (FURS).
- Patients in whom primary ureteral access has failed because of a tight or tortuous ureter.
- Patients in whom a DJ ureteral stent has been placed following failed primary ureteral access.
- Patients willing to undergo repeat FURS after two or four weeks of preoperative ureteral stenting.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients with lower ureteric stones or renal/upper ureteric stones >20 mm.
- Patients with active urinary tract infection, defined as urine culture showing ≥10⁵ CFU/mL of a pathogenic organism or body temperature ≥38°C at the time of repeat FURS.
- Patients with uncorrected coagulopathy, defined as INR >1.5, platelet count <50,000/µL, or aPTT >1.5 times the laboratory upper limit of normal.
- Patients with significant renal impairment, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Patients with a history of major ureteric surgery or ureteral reconstruction on the affected side.
- Patients requiring emergency intervention because of obstructed infected urinary tract, defined by fever ≥38°C with radiological evidence of urinary obstruction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study proposes a non-randomized controlled trial comparing 2 weeks versus 4 weeks of DJ ureteral stenting in patients whose primary ureteral access failed during an initial attempt at FURS. The purpose is to determine whether a longer stenting period improves subsequent ureteral access.
Participants: Adults aged 18-65 years with renal/upper ureteric stones ≤20 mm and failed primary access.
Read more
Sample size: 198 patients - 99 in each group. Group A: Repeat FURS after 2 weeks of DJ stenting. Group B: Repeat FURS after 4 weeks of DJ stenting. Primary outcome: Successful placement of a 10/12-Fr ureteral access sheath during repeat FURS without additional dilation.
Secondary outcomes: Stone-free rate and USSQ score. Stone-free definition: No residual stone fragment ≥4 mm on NCCT at 4 weeks after FURS.
Analysis: t-test/Mann-Whitney U for numerical variables and Chi-square/Fisher's exact test for categorical variables, with p < 0.05 considered significant.
- Conditions
- Urolithiasis
- Being tested
- Preoperative DJ Ureteral Stenting
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative DJ Ureteral StentingDevice
Placement of a double-J (DJ) ureteral stent following failed primary ureteral access to allow passive ureteral dilatation before repeat flexible ureteroscopy. The duration of preoperative stenting will be approximately two weeks in Group 1 and four weeks in Group 2.
| Study group | Role | What they receive |
|---|---|---|
| 2-Week Stenting Group | Experimental | Patients with failed primary ureteral access who undergo repeat flexible ureteroscopy (FURS) after approximately two weeks of preoperative DJ ureteral stenting. Receives: Device: Preoperative DJ Ureteral Stenting |
| 4-Week Stenting Group | Active comparator | Patients with failed primary ureteral access who undergo repeat flexible ureteroscopy (FURS) after approximately four weeks of preoperative DJ ureteral stenting. Receives: Device: Preoperative DJ Ureteral Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful ureteral access during repeat flexible ureteroscopy
Successful ureteral access will be defined as successful advancement and placement of a predetermined 10/12-Fr ureteral access sheath during repeat flexible ureteroscopy without requiring additional preoperative ureteral dilatation or abandoning the procedure. The outcome will be recorded as Yes/No.
Measured: At repeat flexible ureteroscopy, approximately 2 or 4 weeks after initial failed ureteral access.
Secondary outcomes (1)
Ureteral Stent Symptom Questionnaire (USSQ) score
Comparison of the mean Ureteral Stent Symptom Questionnaire (USSQ) score between patients undergoing repeat FURS after two versus four weeks of preoperative DJ ureteral stenting.
Measured: At repeat FURS, approximately 2 or 4 weeks after DJ stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Model description
- Participants with failed primary ureteral access will undergo DJ ureteral stenting and will be allocated to two groups. Group A will undergo repeat flexible ureteroscopy after 2 weeks of stenting, while Group B will undergo repeat flexible ureteroscopy after 4 weeks. Successful ureteral access during repeat FURS will be assessed as the primary outcome, with USSQ score and stone-free rate assessed as secondary outcomes.
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuhd Tariq, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868874
- Sponsor's protocol ID
- PGHI-IRB (DME)-RCD-06-D112
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Versus Four Weeks of Ureteral Stenting Prior to Ureteroscopy After Failed Primary Ureteral Access
- ClinicalTrials.gov ID
- NCT07868874
- Acronym / sponsor ID
- PGHI-IRB (DME)-RCD-06-D112
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Oct 2026 (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.
This study proposes a non-randomized controlled trial comparing 2 weeks versus 4 weeks of DJ ureteral stenting in patients whose primary ureteral access failed during an initial attempt at FURS. The purpose is to determine whether a longer stenting period improves subsequent ureteral access.
Participants: Adults aged 18-65 years with renal/upper ureteric stones ≤20 mm and failed primary access.
Sample size: 198 patients - 99 in each group. Group A: Repeat FURS after 2 weeks of DJ stenting. Group B: Repeat FURS after 4 weeks of DJ stenting. Primary outcome: Successful placement of a 10/12-Fr ureteral access sheath during repeat FURS without additional dilation.
Secondary outcomes: Stone-free rate and USSQ score. Stone-free definition: No residual stone fragment ≥4 mm on NCCT at 4 weeks after FURS.
Analysis: t-test/Mann-Whitney U for numerical variables and Chi-square/Fisher's exact test for categorical variables, with p < 0.05 considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with failed primary ureteral access will undergo DJ ureteral stenting and will be allocated to two groups. Group A will undergo repeat flexible ureteroscopy after 2 weeks of stenting, while Group B will undergo repeat flexible ureteroscopy after 4 weeks. Successful ureteral access during repeat FURS will be assessed as the primary outcome, with USSQ score and stone-free rate assessed as secondary outcomes.
| Arm | Type | Receives |
|---|---|---|
| 2-Week Stenting Group | Experimental | Device: Preoperative DJ Ureteral StentingPatients with failed primary ureteral access who undergo repeat flexible ureteroscopy (FURS) after approximately two weeks of preoperative DJ ureteral stenting. |
| 4-Week Stenting Group | Active comparator | Device: Preoperative DJ Ureteral StentingPatients with failed primary ureteral access who undergo repeat flexible ureteroscopy (FURS) after approximately four weeks of preoperative DJ ureteral stenting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-65 years of either gender presenting with renal and/or upper ureteric calculi ≤20 mm requiring flexible ureteroscopy (FURS).
- Patients in whom primary ureteral access has failed because of a tight or tortuous ureter.
- Patients in whom a DJ ureteral stent has been placed following failed primary ureteral access.
- Patients willing to undergo repeat FURS after two or four weeks of preoperative ureteral stenting.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Patients with lower ureteric stones or renal/upper ureteric stones >20 mm.
- Patients with active urinary tract infection, defined as urine culture showing ≥10⁵ CFU/mL of a pathogenic organism or body temperature ≥38°C at the time of repeat FURS.
- Patients with uncorrected coagulopathy, defined as INR >1.5, platelet count <50,000/µL, or aPTT >1.5 times the laboratory upper limit of normal.
- Patients with significant renal impairment, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Patients with a history of major ureteric surgery or ureteral reconstruction on the affected side.
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 |
|---|---|---|
| Preoperative DJ Ureteral StentingPlacement of a double-J (DJ) ureteral stent following failed primary ureteral access to allow passive ureteral dilatation before repeat flexible ureteroscopy. The duration of preoperative stenting will be approximately two weeks in Group 1 and four weeks in Group 2. | Device | 2-Week Stenting Group, 4-Week Stenting Group |
Primary outcome
Successful ureteral access during repeat flexible ureteroscopy
Time frame: At repeat flexible ureteroscopy, approximately 2 or 4 weeks after initial failed ureteral access.
Successful ureteral access will be defined as successful advancement and placement of a predetermined 10/12-Fr ureteral access sheath during repeat flexible ureteroscopy without requiring additional preoperative ureteral dilatation or abandoning the procedure. The outcome will be recorded as Yes/No.
1 secondary outcome
Ureteral Stent Symptom Questionnaire (USSQ) score
Time frame: At repeat FURS, approximately 2 or 4 weeks after DJ stent placement
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 13 Oct 2026.
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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.
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 Preoperative DJ Ureteral Stenting in people with Urolithiasis, run by PAEC General Hospital, Islamabad 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 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: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. 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?
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?
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?
Successful ureteral access during repeat flexible ureteroscopy (time frame: At repeat flexible ureteroscopy, approximately 2 or 4 weeks after initial failed ureteral access.). 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 Oct 2026.