Quality of Life in Kidney Stone Patients Undergoing Surgery

July 30, 2021 updated by: University of California, San Francisco

Randomized Controlled Clinical Trial Comparing Ureteroscopic to Percutaneous Removal for the 1-2 cm Calculus Measuring Quality of Life as the Primary Outcome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In United States, the prevalence of renal stone is 8.8% with slight predomination in male than female. They can be symptomatic marked by symptoms of flank pain, hematuria or urinary tract infection, or completely asymptomatic and incidentally discovered. Three modalities are accepted as treatment options for renal stone, including shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL) and ureteroscopy (URS). While some standard guidelines were proposed for appropriate treatment selection with regard to stone size, no recommendations or guidelines exist for the surgical management of 1-2 cm renal stones. Both PNL and URS are equally accepted as treatment options for stones at this size. The selection of either procedure currently is left to the treating surgeon can be influenced by anatomical or stone factors as well as patient preference. For URS, frequent requirement for postoperative ureteral stents may result in significant morbidity and a detriment to quality of life owing to irritating bladder symptoms caused by the stent itself. PNL rarely requires postoperative ureteral stent but it may bring longer operative time and hospitalization. PNL therefore may be a treatment option that preserves quality of life compared to URS for patients presenting with the 1-2 cm sized kidney or ureteral stone.

One reasonable way to evaluate efficacy of treatment options is to assess patient's quality of life resultant from the selected modality. Quality of life for renal stone formers is an important but under-studied facet of nephrolithiasis management that should be incorporated into clinical decision making.

The short form-36 health survey questionnaire (SF-36) is a patient-reported survey of health status. It has been validated and is commonly used to determine the efficacy of a given health treatment in many settings, including urologic intervention. The Ureteral Stent Symptom Questionnaire (USSQ) is a validated and widely accepted instrument to evaluate the impact of ureteral stents on quality of life. The investigators plan to use these two questionnaires as a standard outcome measurement to compare impact on quality of life in patients randomized to undergo two different modalities (PNL versus URS) of stone treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ureteroscopy
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
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.
Other Names:
  • URS
Active Comparator: Percutaneous nephrolithotomy
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
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.
Other Names:
  • PNL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of overall quality of life (QOL) score as measured by Short form-36 (SF-36) Questionnaire at early postoperative period
Time Frame: Change from baseline score at 1 week after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of overall quality of life (QOL) score as measured by Ureteral Stent Symptom Questionnaire (USSQ) at early postoperative period
Time Frame: Change from baseline score at 1 week after surgery
This instrument consisted of 38 questions in 6 non-uniformed categories with response ranging from the least (best QOL) to the most (poor QOL).
Change from baseline score at 1 week after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of overall quality of life (QOL) score as measured by Short form-36 (SF-36) Questionnaire at late postoperative period
Time Frame: Change from baseline score at 3 months after surgery
This instrument consisted of 36 questions with response ranging from 0 (poor QOL) to 100 (best QOL).
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
Time Frame: Change from baseline score at 3 months after surgery
This instrument consisted of 38 questions in 6 non-uniformed categories with response ranging from the least (best QOL) to the most (poor QOL).
Change from baseline score at 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHR15-17595
  • P20DK100863 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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