NCT02501525

Brief Summary

This study will include patients aged between 18 and 70 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 40 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the level of pain felt by patients in the postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

July 11, 2015

Last Update Submit

November 15, 2019

Conditions

Urolithiasis

Keywords

renal stoneretrograde intrarenal surgeryureteral access sheathpain

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain level

    Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).

    Within the first 2 hours after the surgery (RIRS)

  • Postoperative pain level

    Postoperative pain levels of the patients in both groups will be evaluated by using verbal rating score (VRS).

    Within the first 2 hours after the surgery (RIRS)

Study Arms (2)

UAS (+)

ACTIVE COMPARATOR

RIRS with ureteral access sheath: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Device: RIRS with ureteral access sheath

UAS (-)

EXPERIMENTAL

RIRS without ureteral access sheath: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Device: RIRS without ureteral access sheath

Interventions

RIRS with ureteral access sheathDEVICE

Ureteral access sheath will be used during RIRS.

UAS (+)
RIRS without ureteral access sheathDEVICE

Ureteral access sheath will not be used during RIRS.

UAS (-)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 18-70 years old
  • Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone

You may not qualify if:

  • Patients with uncontrolled diabetes mellitus and diabetic nephropathy
  • Patients with blood pressure \> 140/80 mmHg despite regular use of antihypertensive agent(s)
  • Patients with chronic kidney failure who need dialysis
  • Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
  • Patients who have had pyelonephritis 3 months or much earlier
  • Patients younger than 18 years or older than 70 years
  • Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
  • Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
  • Patients using any kind of medication that can affect his/her perception of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

Location

Related Publications (8)

  • Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.

    PMID: 22840867BACKGROUND

  • Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish.

    PMID: 24881777BACKGROUND

  • Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. doi: 10.1089/089277904322836631.

    PMID: 15006050BACKGROUND

  • Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.

    PMID: 11176469BACKGROUND

  • L'esperance JO, Ekeruo WO, Scales CD Jr, Marguet CG, Springhart WP, Maloney ME, Albala DM, Preminger GM. Effect of ureteral access sheath on stone-free rates in patients undergoing ureteroscopic management of renal calculi. Urology. 2005 Aug;66(2):252-5. doi: 10.1016/j.urology.2005.03.019.

    PMID: 16040093BACKGROUND

  • Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. doi: 10.1089/end.2007.9997.

    PMID: 17338606BACKGROUND

  • Lallas CD, Auge BK, Raj GV, Santa-Cruz R, Madden JF, Preminger GM. Laser Doppler flowmetric determination of ureteral blood flow after ureteral access sheath placement. J Endourol. 2002 Oct;16(8):583-90. doi: 10.1089/089277902320913288.

    PMID: 12470467BACKGROUND

  • Torricelli FC, De S, Hinck B, Noble M, Monga M. Flexible ureteroscopy with a ureteral access sheath: when to stent? Urology. 2014 Feb;83(2):278-81. doi: 10.1016/j.urology.2013.10.002. Epub 2013 Nov 12.

    PMID: 24231214BACKGROUND

MeSH Terms

Conditions

UrolithiasisNephrolithiasisPain

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ozcan Kilic, M.D.

    Selcuk University, School of Medicine, Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Assoc. Prof. Dr.

Study Record Dates

First Submitted

July 11, 2015

First Posted

July 17, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)