Enrolling by invitationNCT07868874Updated Oct 13, 2026

Comparison of Two Versus Four Weeks of Ureteral Stenting Prior to Ureteroscopy After Failed Primary Ureteral Access

An interventional study of Preoperative DJ Ureteral Stenting in Urolithiasis, sponsored by PAEC General Hospital, Islamabad. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by PAEC General Hospital, Islamabad · Not applicable, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 198
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

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.

Conditions studied

Urolithiasis

Browse trials for

Urolithiasis 281

In context

Urolithiasis

281 studies on the registry are indexed under Urolithiasis; 71 are open to participants now.

This study's planned enrollment of 198 is above the median of 102 across 200 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

PAEC General Hospital, Islamabad is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 198 participants (estimated)

Study arms

Experimental
2-Week Stenting Group
Patients with failed primary ureteral access who undergo repeat flexible ureteroscopy (FURS) after approximately two weeks of preoperative DJ ureteral stenting.
Device: Preoperative DJ Ureteral Stenting
Active comparator
4-Week Stenting Group
Patients with failed primary ureteral access who undergo repeat flexible ureteroscopy (FURS) after approximately four weeks of preoperative DJ ureteral stenting.
Device: Preoperative DJ Ureteral Stenting

Interventions

DevicePreoperative DJ Ureteral Stenting
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.

What researchers measure

Primary outcomes

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.
Time frame: At repeat flexible ureteroscopy, approximately 2 or 4 weeks after initial failed ureteral access.

Secondary outcomes

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.
Time frame: At repeat FURS, approximately 2 or 4 weeks after DJ stent placement

Study locations

1 site

PAEC General Hospital Islamabad
Islamabad, Fedral 44000, Pakistan

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.

Of 94 non-industry interventional studies with no phase under Urolithiasis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 5 months is below that.

Counting every sponsor, half of 104 studies reached it within 20 months; a quarter within 11 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 4, 2026
First posted: Oct 9, 2026
StartActual: Oct 1, 2026
Primary completionEst.: Mar 31, 2027
CompletionEst.: Mar 31, 2027
Last update: Oct 13, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 9, 2026

Show all 1 update

Oct 9, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07868874
Lead sponsor: PAEC General Hospital, Islamabad
Responsible party: Zuhd Tariq (Principle Investigator, PAEC General Hospital, Islamabad) — Principal investigator
First posted: Oct 9, 2026
Start date: Oct 1, 2026
Primary completion: Mar 31, 2027 (estimated)
Completion: Mar 31, 2027 (estimated)
Last update: Oct 13, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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