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Enrolling by Invitation

NCT Number: NCT06979583

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

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

Enrolling by Invitation

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Key information

Conditions

Ureteral Stent-Related Symptom Retrograde Intra-renal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4.8 Fr Ureteral stents

Device

After surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed.

7 Fr Ureteral stents

Device

After surgery, patients will have the Bard 7 Fr ureteral stent placed.

Primary outcomes

  1. 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)

    Post-operatively, patient will be contacted by study coordinators every day until stent is removed (usually 7-14 days after the surgery) to scale their stent pain on a scale from 1-5 as following: No pain: 1; Mild pain with no need for additional medication: 2; Mild pain with need for additional medication (anticholinergics): 3; Moderate stent pain (requiring narcotics): 4; Severe stent pain (requiring ER visit): 5.

Secondary outcomes

  1. Volume of post-operative correspondence between patients and medical system.

    Time frame: 14 days

    Total number of communications received from patient post-operatively.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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