Retrograde Intra-renal Surgery, Ureteral Stent-Related Symptom
Conditions
Brief summary
The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort.
Interventions
DEVICE4.8 Fr Ureteral stents
After surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed.
DEVICE7 Fr Ureteral stents
After surgery, patients will have the Bard 7 Fr ureteral stent placed.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string | 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
| Measure | Time frame | Description |
|---|---|---|
| Volume of post-operative correspondence between patients and medical system. | 14 days | Total number of communications received from patient post-operatively. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeghan A. Cooper, DO
Mayo Clinic
Outcome results
None listed