Trials Sponsors Conditions Drugs Pricing

Conditions

Retrograde Intra-renal Surgery Ureteral Stent-Related Symptom

Outcome Measures

Primary Outcomes (1)

Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string
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.
Starting post-operatively, daily, until stent is removed (estimated 7-14 days)

Secondary Outcomes (1)

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

Study Arms (2)

Group A: 4.8 Fr Ureteral stents

EXPERIMENTAL

Device: 4.8 Fr Ureteral stents

Group B: 7 Fr Ureteral stents

EXPERIMENTAL

Device: 7 Fr Ureteral stents

Interventions

4.8 Fr Ureteral stentsDevice

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

Group A: 4.8 Fr Ureteral stents

7 Fr Ureteral stentsDevice

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

Group B: 7 Fr Ureteral stents

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Study Officials

Meghan A. Cooper, DO
Mayo Clinic
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 20, 2025

Study Start

March 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

May 2027

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group A: 4.8 Fr Ureteral stents

Group B: 7 Fr Ureteral stents

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group A: 4.8 Fr Ureteral stents

Group B: 7 Fr Ureteral stents

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Data Sharing

Source record

Locations