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ESWL for Distal Ureteric Stone: Supine Versus Prone

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ClinicalTrials.gov Identifier: NCT02298465
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Brian Ho, Queen Mary Hospital, Hong Kong

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE November 24, 2014
Last Update Posted Date September 16, 2020
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Stone-free rate [ Time Frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks. ]
To review KUB to determine if distal ureteric stone have been passed
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
  • Complications rates concerning the two approaches of ESWL [ Time Frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks. ]
    To see if any complications arise from the procedures
  • Pain associated with the procedure for the two approaches of ESWL [ Time Frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks. ]
    • Using visual analogue scale to determine the pain scores of each intervention on the day of intervention
    • Number of tablets of analgesics used in-between follow up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ESWL for Distal Ureteric Stone: Supine Versus Prone
Official Title  ICMJE Randomized Controlled Study on Extracorporeal Shockwave Lithotripsy for Distal Ureteric Stone: Transgluteal Versus Traditional Prone Approach
Brief Summary

Extracorporeal shockwave lithotripsy (ESWL) for urinary stone is common and widespread nowadays. Approximately 80% of urinary stones are treated by ESWL. Traditionally distal ureteric stones are treated with ESWL in the prone position. However, as some patients cannot tolerate lying in the prone due to medical illness such as chronic obstructive pulmonary disease (COPD), some authors have reported using the supine approach of ESWL for treatment of distal ureter stones. No serious complications had developed in the patients who underwent supine approach. Only minor complications such as self-limiting blood in the urine, painful passage of urine, or local pain that had responded to oral painkillers. There were no serious complications encountered in children as well. In the most recent retrospective review by Tolley et al, they had revealed that patients who had underwent supine ESWL for distal ureteric stones had an improved stone-free rate compared with the traditional prone approach.

Patient with radio-opaque distal ureteric stones (stones below the sacroiliac joint) on KUB X-ray, who have opted for ESWL treatment, are randomized into two groups: one undergoing ESWL in the supine position and the other undergoing ESWL in the prone position. Patients will be observed for two hours after ESWL before being discharged. Oral painkillers as necessary will be provided to the patient. The patients will have a KUB Xray at 2 weeks post-ESWL, and then monthly afterwards if required. If there are residual stones at the 2-week follow-up, the patient will be offered ESWL again. Patients are free to withdraw from the study at any time and will continue to be managed as per usual.

The investigators aim to have 130 patients, with 65 patients in each group with an interim analyses to be performed when 66 patients have been recruited (33 patients in each group).

Detailed Description Previous authors have reported using the greater and lesser sciatic foramina as a pathway for the shockwaves to reach the distal ureter. No serious complications had developed in the patients who underwent transgluteal approach. Only minor complications such as self-limiting hematuria, dysuria, or pain that had responded to oral analgesics. There were no serious complications encountered in children as well. In the most recent retrospective review by Tolley et al, they had revealed that patients who had underwent transgluteal ESWL for distal ureteric stones had an improved stone-free rate of 78% in the transgluteal group versus 40% in the prone group after one session of shockwave lithotripsy and a stone-free rate of 92% versus 63% respectively after two sessions of shockwave lithotripsy. This has been speculated to be due to the presence of bowel gas attenuating the shockwaves as well as a long skin-to-stone distance in the prone position.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Tract Stones
  • Urinary Stones
  • Urinary Calculi
Intervention  ICMJE
  • Procedure: Supine ESWL
    ESWL to distal ureteric stone is performed in the supine position with the shockwave generator placed in the patient's buttock area. The aim is to direct the shockwaves through the greater and lesser sciatic foramina to reach the distal ureter.
  • Procedure: Prone ESWL
    ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen
    Other Name: Transgluteal
  • Device: Extracorporeal Shockwave Lithotripsy (ESWL)
    The ESWL machine we use is the Dornier S2 lithotriptor. ESWL is performed without any sedation or anesthesia under fluoroscopy. Painkillers are given upon request.
Study Arms  ICMJE
  • Active Comparator: Prone ESWL
    ESWL for distal ureteric stone is performed in the traditional prone position
    Interventions:
    • Procedure: Prone ESWL
    • Device: Extracorporeal Shockwave Lithotripsy (ESWL)
  • Experimental: Supine ESWL
    ESWL for distal ureteric stone is performed in the supine position, with the shockwave generator head placed at a 30 degree angle to the vertical at the patient's gluteal muscles. Thus, the shockwaves will travel via the greater and lesser sciatic foramina to reach the stone
    Interventions:
    • Procedure: Supine ESWL
    • Device: Extracorporeal Shockwave Lithotripsy (ESWL)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2014)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2027
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients, over 18 years of age, with distal ureteric stones with stone size of ≥3mm on kidney-ureter-bladder (KUB) X-ray who opted for ESWL treatment

Exclusion Criteria:

  • Patients who are unable to provide consent
  • radiolucent stones
  • active urinary tract infections
  • pregnancy
  • uncontrolled hypertension
  • uncontrolled bleeding tendencies
  • severe skeletal malformations
  • arterial aneurysms within the vicinity of the stone (such as iliac artery aneurysms)
  • unable to assume the appropriate position (prone or supine) for ESWL
  • solitary kidneys
  • transplanted kidneys
  • presence of ureteric stents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brian Ho, MBBS (852)2255-3023 brianshho@gmail.com
Contact: Sau Loi Ng, BN, DN (852)2255-3625 ngsauloi2009@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02298465
Other Study ID Numbers  ICMJE QueenMaryH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Ho, Queen Mary Hospital, Hong Kong
Study Sponsor  ICMJE Queen Mary Hospital, Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Ho, MBBS Queen Mary Hospital, Hong Kong
PRS Account Queen Mary Hospital, Hong Kong
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP