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CompletedNCT02501525Updated Nov 18, 2019

Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing RIRS

An interventional study of RIRS with ureteral access sheath and RIRS without ureteral access sheath in Urolithiasis, sponsored by Selcuk University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Selcuk University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The level of pain of the patients in both groups will be evaluated by using visual analog score (VAS) and verbal rating score (VRS) in the postoperative 0 min (the moment patients gets consciousness after he/she wakes up from general anesthesia), 10th min, 30th min, 60th min and 120th min.

02

Conditions studied

  • Urolithiasis

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Keywords

  • renal stone
  • retrograde intrarenal surgery
  • ureteral access sheath
  • pain
03

In context

Urolithiasis

278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 197 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Selcuk University is the lead sponsor of 248 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    UAS (+)

    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

  • Experimental
    UAS (-)

    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

  • DeviceRIRS with ureteral access sheath

    Ureteral access sheath will be used during RIRS.

  • DeviceRIRS without ureteral access sheath

    Ureteral access sheath will not be used during RIRS.

06

What researchers measure

Primary outcomes

  1. Postoperative pain level

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

    Time frame: Within the first 2 hours after the surgery (RIRS)

  2. Postoperative pain level

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

    Time frame: Within the first 2 hours after the surgery (RIRS)

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Study locations

1 site
  • Selcuk University, School of Medicine, Department of Urology
    Konya, 42075, Turkey
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References and documents

Publications

  • 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. PubMed 22840867 ↗
  • 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. PubMed 24881777 ↗
  • 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. PubMed 15006050 ↗
  • Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93. PubMed 11176469 ↗
  • 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. PubMed 16040093 ↗
  • 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. PubMed 17338606 ↗
  • 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. PubMed 12470467 ↗
  • 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. PubMed 24231214 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02501525
Lead sponsor
Selcuk University
Responsible party
Ozcan Kilic (M.D., Assoc. Prof. Dr., Selcuk University) — Principal investigator
First posted
Jul 17, 2015
Start date
Aug 2015
Primary completion
May 2016
Completion
May 2016
Last update
Nov 18, 2019

Study contacts

Ozcan Kilic, M.D.
principal investigator · Selcuk University, School of Medicine, Department of Urology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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