Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02298465

ESWL for Distal Ureteric Stone: Supine Versus Prone

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urinary Tract Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urinary Stones Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supine ESWL

Procedure

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.

Prone ESWL

Procedure

ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen

Other names: Transgluteal

Extracorporeal Shockwave Lithotripsy (ESWL)

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Ho, MBBS

CONTACT

[email protected]

(852)2255-3023

Sau Loi Ng, BN, DN

CONTACT

[email protected]

(852)2255-3625

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Official study title

Randomized Controlled Study on Extracorporeal Shockwave Lithotripsy for Distal Ureteric Stone: Transgluteal Versus Traditional Prone Approach

Important dates

Study start
2014
Primary completion
2025
Study completion
2027
First posted
Nov 24, 2014
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.