Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones (ENORC)

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ClinicalTrials.gov Identifier: NCT03657667

Recruitment Status : Recruiting

First Posted : September 5, 2018

Last Update Posted : July 27, 2022

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Brigham and Women's Hospital

Henry Ford Health System

Milton S. Hershey Medical Center

Baylor Scott and White Health

Indiana University

University of Minnesota

University of California, Davis

Vanderbilt University Medical Center

University of California, San Diego

University of California, Los Angeles

Mayo Clinic

Information provided by (Responsible Party):

Centre hospitalier de l'Université de Montréal (CHUM)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kidney Stone	Procedure: Ureteroscopy	Not Applicable

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Detailed Description:

Research Protocol

Title of research project: Evaluation of pain before and after removal of non-obstructing renal calculi.
Identification of Principal Investigator: Dr. Naeem Bhojani
Multicentric study

Rationale & background information Renal stone disease is a common condition representing a lifetime occurrence risk of 10% in men and 7% in women. Renal stone disease is a chronic condition with a high recurrence rate. Additionally, renal stone disease is associated with considerable morbidity including pain. 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. This increases the intraluminal pressure of the urinary collecting system and stretches nerve ending in the ureteral mucosa and renal capsule. Non-obstructing renal calculi that do not cause renal collecting system dilatation are thought to be painless. There is however, some evidence that non-obstructing renal calculi located within the renal calyces actually do cause pain. In a small (n=13) retrospective study, it was found that ureteroscopic removal of non-obstructing renal calyceal stones achieved complete or partial resolution of pain in all patients. The reason for this pain is unknown.

Objective and hypothesis Objective 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.

Hypothesis We hypothesize that the removal of non-obstructing renal calculi will decrease or eliminate the participant's pain and will improve their quality of life.

Design and methodology

Study type:

o Prospective multicentric study

Study population:

o Patients with non-obstructing renal calculi

Inclusion criteria:

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)

Exclusion criteria:

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

Methodology Our experimental plan begins with the identification of patients with non-obstructing kidney stones (< =10 mm (maximum length; measured via CT) with associated flank pain. Once all other causes of the pain have been eliminated, these patients will undergo ureteroscopy (URS) (standard treatment) to remove the offending kidney stones.

URS will be performed in the standard fashion including the use of a guide wire +/- a ureteral access sheath. Laser lithotripsy will be performed if necessary and all fragments will be extracted with the use of a basket and will be sent for stone analysis. Once the offending stone(s) has/have been removed a double J ureteral stent will be placed if deemed necessary by the surgeon. The duration of the double J ureteral stent will be determined by the surgeon.

All consented patients will undergo 3 evaluations preoperatively; The Brief Pain Inventory (BPI) (short version)[3], the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain inference/form 6b and the Wisconsin stone quality of life questionnaire (WSQOL). After removal of the renal calculi, these 3 forms will be completed by the participant at the time of stent removal or if no stent was placed, at 2 weeks post-operatively. Thereafter, the forms will be completed again at 6-8 weeks (+/- 1 week) after the initial procedure or 4 weeks (+/- 1 week) after the removal of their double J stent. Finally, the evaluations will be repeated at 12 weeks. Additionally, as with standard care at 6-8 weeks each patient will undergo post-operative imaging to determine if any renal calculi remain.

Analysis of Data With regards to the BPI, if removal of the offending kidney stone(s) is the cause of the patient's pain we expect a decrease in pain ("pain at its worst in the last 24 hours") of at least 20%. Patients included in this study should experience moderate to elevated flank pain in order to be able to detect a decrease of 20% of this pain post-intervention. This decrease will be considered clinically significant. In order to test our hypothesis, we plan to recruit a minimum of 53 patients to achieve a power of 80%. Patients will be their own control.

Sample size calculation Sample size calculation was performed using GPower software, version 3.1. Considering a baseline means Visual Analog Scale (VAS) of 7, we conservatively supposed a correlation of 0 and a standard deviation of 2.5. The standard deviation was estimated with the range (i.e. σ ≈ range/4), assuming the VAS to be normally distributed. Thus, a sample size of n = 53 is required to ensure at least 80% power to detect a clinically significant difference of 20 % (post-mean = 5.6), at a significance level of 5 %.

Impact of the Proposed Research The results of this study will conceivably provide significant evidence on whether small non-obstructing renal calculi can cause flank pain.

Ethical considerations

All personal identifiers, such as patients' names, will be removed and replaced with a unique numerical code.
Only the principal investigator and approved study staff will be able to identify the patients and have access to the study files.
The consent will be kept in a locked office at the Research Center of the University of Montéral Hospital Center (CRCHUM).
The data collected will be protected in files with a password on secure servers (computers).
The data will be kept during a period of 10 years on secured computers with passwords by the principal investigator of this research project at the CRCHUM. After that, they will be destroyed.
The combined results from this study may be used to prepare reports and summaries for scientific publications and presentations at scientific meetings. If they are, identity of the patients will remain confidential.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	53 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones
Actual Study Start Date :	August 28, 2018
Estimated Primary Completion Date :	April 28, 2023
Estimated Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Kidney stones

MedlinePlus related topics: Kidney Stones

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Ureteroscopy (URS) (standard treatment) Endoscopic procedure used to remove kidney stones	Procedure: Ureteroscopy Endoscopic removal of kidney stones

Outcome Measures

Primary Outcome Measures :

Evaluation of pain [ Time Frame: 12 weeks ]
evaluated using The Brief Pain Inventory; scale from 0-10; worst pain is 10

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657667

Contacts

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Contact: Naeem Bhojani, MD	514-890-8000 ext 14069	naeem.bhojani@gmail.com
Contact: Kahina Bensaadi, DESS	514-890-8000 ext 30824	kahina.bensaadi.chum@ssss.gouv.qc.ca

Locations

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United States, California
University of California, Davis	Recruiting
Davis, California, United States, 95616
Contact: Noah Convasser, MD avij@ucdavis.edu
University of California, San Diego	Recruiting
San Diego, California, United States, 92093
Contact: Seth Bechis, MD sbechis@ucsd.edu
United States, Indiana
Indiana University	Recruiting
Bloomington, Indiana, United States, 47405
Contact: Marcelino Rivera, MD cstoughton@iuhealth.org
United States, Massachusetts
Brigham And Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Daniel Wollin, MD daniel.wollin@gmail.com
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Micheal Borofsky, MD mborofsk@umn.edu
United States, Pennsylvania
Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: John Knoedler, MD jknoedler@pennstatehealth.psu.edu
United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ryan Hsi, MD ryan.hsi@vanderbilt.edu
United States, Texas
Baylor Scott and White Health	Recruiting
Temple, Texas, United States, 76508
Contact: Marawan El Tayeb, MD marawan.eltayeb@bswhealth.org
Canada, Quebec
Centre Hospitalier de l'université de Montréal (CHUM)	Recruiting
Montréal, Quebec, Canada, H2X0A9
Contact: Kahina Bensaadi, DESS 5148908000 ext 30824 kahina.bensaadi.chum@ssss.gouv.qc.ca
Contact: Amal Nadiri, PhD 5148908000 ext 26074 amalnadiri@gmail.com

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Brigham and Women's Hospital

Henry Ford Health System

Milton S. Hershey Medical Center

Baylor Scott and White Health

Indiana University

University of Minnesota

University of California, Davis

Vanderbilt University Medical Center

University of California, San Diego

University of California, Los Angeles

Mayo Clinic

Investigators

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Principal Investigator:	Naeem Bhojani, MD	Centre hospitalier de l'Université de Montréal (CHUM)

More Information

Publications of Results:

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.

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.

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

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.

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.

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.

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.

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.

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Responsible Party:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT03657667
Other Study ID Numbers:	17.314
First Posted:	September 5, 2018 Key Record Dates
Last Update Posted:	July 27, 2022
Last Verified:	March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):


Renal Stone Nephrolithiasis Painful stone in kidney Kidney stone pain

Additional relevant MeSH terms:

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Kidney Calculi Nephrolithiasis Calculi Pathological Conditions, Anatomical	Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi

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