Quality of Life in Kidney Stone Patients Undergoing Surgery

NCT02625051 | Completed

• 2 other identifiers: CHR15-17595P20DK100863
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized study, comparing quality of life in renal stone patients undergoing surgical treatment with ureteroscopy (URS) versus percutaneous nephrolithotomy (PNL).

Conditions

Kidney Calculi; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change of overall quality of life (QOL) score as measured by Short form-36 (SF-36) Questionnaire at early postoperative period

  This instrument consisted of 36 questions with response ranging from 0 (poor QOL) to 100 (best QOL).

  Change from baseline score at 1 week after surgery

Secondary Outcomes (1)

• Change of overall quality of life (QOL) score as measured by Ureteral Stent Symptom Questionnaire (USSQ) at early postoperative period

  Change from baseline score at 1 week after surgery

Other Outcomes (2)

• Change of overall quality of life (QOL) score as measured by Short form-36 (SF-36) Questionnaire at late postoperative period

  Change from baseline score at 3 months after surgery

• Change of overall quality of life (QOL) score as measured by Ureteral Stent Symptom Questionnaire (USSQ) at late postoperative period

  Change from baseline score at 3 months after surgery

Study Arms (2)

Ureteroscopy

ACTIVE COMPARATOR

Kidney stone of participants in this arm will be treated with ureteroscopy (URS). A ureteral stent will be inserted at the end of the procedure.

Procedure: Ureteroscopy

Percutaneous nephrolithotomy

ACTIVE COMPARATOR

Kidney stone of participants in this arm will be treated with percutaneous nephrolithotomy (PNL). A percutaneous nephrostomy tube will be inserted at the end of the procedure.

Procedure: Percutaneous nephrolithotomy

Interventions

Ureteroscopy PROCEDURE

Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. A safety guide-wire is then placed into renal pelvis, followed by a ureteral access sheath to maintain low intra-renal pressure, and to facilitate the procedures. Using flexible ureteroscope, renal or proximal ureteral stone is identified and fragmented with a holmium laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.

Also known as: URS

Ureteroscopy

Percutaneous nephrolithotomy PROCEDURE

Under general anesthesia, an open-ended 5 french ureteral exchange catheter is placed into the ipsilateral ureter under cystoscopic guidance. The patient is then safely turned and secured in the prone position. Percutaneous renal access is obtained under ultrasonographic or fluoroscopic guidance. Either a 24 or 30 french sheath is advanced in the kidney and nephroscopy is performed with a rigid offset nephroscope. Stone fragmentation is accomplished using a dual CyberWand lithotripter or holmium laser lithotripsy. Flexible nephroscopy is performed to look for possible residual fragments and basket extraction is done for complete clearance of stone.

Also known as: PNL

Percutaneous nephrolithotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a renal or proximal ureteral stone measuring 1-2 cm in size on preoperative ultrasound, computed tomography, or plain radiographic imaging

You may not qualify if:

• Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
• Stones with measured size larger than 2 cm or smaller than 1 cm.
• Patients with ureteral or renal anatomy or stones located in a position judged to be unsafe for randomization.
• Pregnancy.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (12)

• Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.

  PMID: 22498635 BACKGROUND

• Pearle MS, Calhoun EA, Curhan GC; Urologic Diseases of America Project. Urologic diseases in America project: urolithiasis. J Urol. 2005 Mar;173(3):848-57. doi: 10.1097/01.ju.0000152082.14384.d7.

  PMID: 15711292 BACKGROUND

• Tiselius HG, Ackermann D, Alken P, Buck C, Conort P, Gallucci M; Working Party on Lithiasis, European Association of Urology. Guidelines on urolithiasis. Eur Urol. 2001 Oct;40(4):362-71. doi: 10.1159/000049803.

  PMID: 11713390 BACKGROUND

• Kumar A, Kumar N, Vasudeva P, Kumar Jha S, Kumar R, Singh H. A prospective, randomized comparison of shock wave lithotripsy, retrograde intrarenal surgery and miniperc for treatment of 1 to 2 cm radiolucent lower calyceal renal calculi: a single center experience. J Urol. 2015 Jan;193(1):160-4. doi: 10.1016/j.juro.2014.07.088. Epub 2014 Jul 24.

  PMID: 25066869 BACKGROUND

• Duvdevani M, Chew BH, Denstedt JD. Minimizing symptoms in patients with ureteric stents. Curr Opin Urol. 2006 Mar;16(2):77-82. doi: 10.1097/01.mou.0000193375.29942.0f.

  PMID: 16479208 BACKGROUND

• Haleblian G, Kijvikai K, de la Rosette J, Preminger G. Ureteral stenting and urinary stone management: a systematic review. J Urol. 2008 Feb;179(2):424-30. doi: 10.1016/j.juro.2007.09.026.

  PMID: 18076928 BACKGROUND

• Kirac M, Bozkurt OF, Tunc L, Guneri C, Unsal A, Biri H. Comparison of retrograde intrarenal surgery and mini-percutaneous nephrolithotomy in management of lower-pole renal stones with a diameter of smaller than 15 mm. Urolithiasis. 2013 Jun;41(3):241-6. doi: 10.1007/s00240-013-0552-0. Epub 2013 Mar 13.

  PMID: 23483226 BACKGROUND

• Perez-Fentes DA, Gude F, Blanco B, Freire CG. Percutaneous nephrolithotomy: short- and long-term effects on health-related quality of life. J Endourol. 2015 Jan;29(1):13-7. doi: 10.1089/end.2014.0081.

  PMID: 24708396 BACKGROUND

• Barnes KT, Bing MT, Tracy CR. Do ureteric stent extraction strings affect stent-related quality of life or complications after ureteroscopy for urolithiasis: a prospective randomised control trial. BJU Int. 2014 Apr;113(4):605-9. doi: 10.1111/bju.12541.

  PMID: 24765679 BACKGROUND

• Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.

  PMID: 1285753 BACKGROUND

• Staios D, Andrews HO, Shaik T, Buchholz NN. Quality of life after percutaneous nephrolithotomy for caliceal diverticulum and secluded lower-pole renal stones. J Endourol. 2007 May;21(5):515-9. doi: 10.1089/end.2006.0432.

  PMID: 17523905 BACKGROUND

• Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

  PMID: 12576846 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Ureteroscopy; Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Laparoscopy

Study Officials

• Thomas Chi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 9, 2015
• Study Start: July 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 6, 2021

Record last verified: 2021-07

Locations

US (1)