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

Mayo Clinic

Status: Not yet enrolling

Conditions: Retrograde Intra-renal Surgery; Ureteral Stent-Related Symptom

Treatments: Device: 4.8 Fr Ureteral stents; Device: 7 Fr Ureteral stents

Study type: Interventional

Funder types: Other

Identifiers

NCT06979583

24-009000

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group A: 4.8 Fr Ureteral stents

Experimental group

Treatment:

Device: 4.8 Fr Ureteral stents

Group B: 7 Fr Ureteral stents

Experimental group

Treatment:

Device: 7 Fr Ureteral stents