NCT03657667

Brief Summary

Pain associated with renal stone disease is typically caused by an obstructing stone that obstructs the flow of urine, which results in renal collecting system dilatation. Non-obstructing renal calculi that do not cause renal collecting system dilatation are thought to be painless. The objective of this study is to prospectively determine if the removal of non-obstructing renal calculi can reduce or eliminate participant's pain and/or improve their quality of life.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

4.1 years

First QC Date

August 30, 2018

Last Update Submit

April 3, 2023

Conditions

Kidney Stone

Keywords

Renal StoneNephrolithiasisPainful stone in kidneyKidney stone pain

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pain

    evaluated using The Brief Pain Inventory; scale from 0-10; worst pain is 10

    12 weeks

Study Arms (1)

Ureteroscopy (URS) (standard treatment)

OTHER

Endoscopic procedure used to remove kidney stones

Procedure: Ureteroscopy

Interventions

UreteroscopyPROCEDURE

Endoscopic removal of kidney stones

Ureteroscopy (URS) (standard treatment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with renal colic and non-obstructing renal calculi. No stone greater than 10 mm in longest diameter
  • All other causes of pain have been eliminated (by clinical judgment; if the cause of pain is in doubt: assessment by a family doctor or medical specialist will be obtained)
  • Patients older than 18 years old
  • Moderate to severe pain (\> or = 5 on BPI pain scale: pain at its worst in the last 24hrs)

You may not qualify if:

  • Patient's with anatomic abnormalities (calyceal diverticulum)
  • Ureteral calculi
  • Nephrocalcinosis
  • RTA, medullary sponge kidney, sarcoidosis
  • Hydronephrosis or hydrocalycosis
  • Minimal pain (\<5 on BPI pain scale: pain at its worst in the last 24 hrs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California, Davis

Davis, California, 95616, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Indiana University

Bloomington, Indiana, 47405, United States

Location

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Scott and White Health

Temple, Texas, 76508, United States

Location

Centre Hospitalier de l'université de Montréal (CHUM)

Montreal, Quebec, H2X0A9, Canada

Location

Related Publications (8)

  • Travaglini F, Bartoletti R, Gacci M, Rizzo M. Pathophysiology of reno-ureteral colic. Urol Int. 2004;72 Suppl 1:20-3. doi: 10.1159/000076586.

    PMID: 15133328RESULT

  • Jura YH, Lahey S, Eisner BH, Dretler SP. Ureteroscopic treatment of patients with small, painful, non-obstructing renal stones: the small stone syndrome. Clin Nephrol. 2013 Jan;79(1):45-9. doi: 10.5414/CN107637.

    PMID: 23006342RESULT

  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PMID: 8080219RESULT

  • Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.

    PMID: 27889419RESULT

  • Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

    PMID: 16320034RESULT

  • Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain. 2000 Dec 1;88(3):287-294. doi: 10.1016/S0304-3959(00)00339-0.

    PMID: 11068116RESULT

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PMID: 11690728RESULT

  • Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005 Apr 20;5:13. doi: 10.1186/1471-2288-5-13.

    PMID: 15840177RESULT

MeSH Terms

Conditions

Kidney CalculiNephrolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Naeem Bhojani, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 5, 2018

Study Start

August 28, 2018

Primary Completion

October 6, 2022

Study Completion

March 9, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(8)