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

NCT07868874 | Enrolling By Invitation

• 1 other identifier: PGHI-IRB (DME)-RCD-06-D112
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Ureteral Stent Symptom Questionnaire (USSQ) score

  At repeat FURS, approximately 2 or 4 weeks after DJ stent placement

Study Arms (2)

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.

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.

Device: Preoperative DJ Ureteral Stenting

Interventions

Preoperative DJ Ureteral Stenting DEVICE

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.

2-Week Stenting Group; 4-Week Stenting Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

PAEC General Hospital Islamabad

Islamabad, Fedral, 44000, Pakistan

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

PA (1)