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Enrolling by invitation NCT06979583

Impact of Ureteral Stent and Sheaths Size on Post-Operative Pain

No phase Interventional Ureteral Stent-Related Symptom Retrograde Intra-renal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4.8 Fr Ureteral stents, 7 Fr Ureteral stents.
Who it may be relevant to
Registry conditions: Ureteral Stent-Related Symptom, Retrograde Intra-renal Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Ureteral Stent Size on the Management of Post Ureteroscopy Pain: a Randomized Single Blind Trial

Overview

The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort.

Interventions

  • Device 4.8 Fr Ureteral stents
    After surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed.
  • Device 7 Fr Ureteral stents
    After surgery, patients will have the Bard 7 Fr ureteral stent placed.

Primary outcome measures

  • Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string [Time frame: Starting post-operatively, daily, until stent is removed (estimated 7-14 days)]
Secondary outcome measures (1)
  • Volume of post-operative correspondence between patients and medical system. [Time frame: 14 days]

Eligibility criteria

Inclusion criteria

  • Patients undergoing a retrograde intra-renal surgery (RIRS) (only patients undergoing the procedure for stone treatment will be included) who will require post-operative indwelling ureteral stent placement on a string at the conclusion of the procedure.

Exclusion criteria

  • Patients with intra-operative ureteral injury who will require ureteral stent for extended time (more than 10 days, in that case a stent without a string will be used).
  • Patient undergoing ureteroscopy for any indication other than stone extraction.
  • Patients who are currently pregnant as determined by clinical presurgical screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06979583 · 24-009000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗