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WithdrawnNCT01739738Updated Mar 25, 2020

The Impact of Ureteral Stents on Peristalsis

An observational study in Kidney Stones, Tumor and Hydronephrosis, sponsored by University of British Columbia. Withdrawn at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of British Columbia · Observational

Why this study was withdrawn
Study did not start
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of the study is to investigate the impact of ureteral stents on the functioning of ureteral peristalsis (normal contractions in the ureteral organ muscle).

Read the detailed description

Ureteral stents are commonly used in the field of urology to maintain urinary drainage and are inserted into ureters of patients who suffer from kidney stones, urinary tract infections or cancer. Usually the muscle cells of the ureter contract in a coordinated fashion (peristalsis) in order to provide urinary flow from the kidney into the bladder. By inserting a stent these contractions are disrupted, eventually resulting in a loss of peristalsis. This phenomena is accompanied by swelling of the kidney and pain, which are well-known negative side effects of stents. To avoid stent-related morbidity and improve patients care this issue needs to be investigated further. A first step is to analyse the impact of stents on peristalsis and to possibly bring these results into context with hypothesised molecular mechanisms involved in peristalsis.

02

Conditions studied

  • Kidney Stones
  • Tumor
  • Hydronephrosis

Keywords

  • peristalsis, kidney stones, hydronephrosis, ureteral stent
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who require unilateral insertion of a ureteral stent for the following indications will be included in this clinical trial:

  1. stone disease
  2. localized tumor disease
  3. hydronephrosis of unknown ethiology
  4. patients who receive a prophylactic stent before a planned operation

Eligibility criteria

Inclusion Criteria:

  1. stone disease
  2. localized tumor disease
  3. hydronephrosis of unknown ethiology
  4. patients who receive a prophylactic stent before a planned operation.

Exclusion Criteria:

  1. Patients being septic and in a life-threatening condition before or after stent-insertion
  2. patients with tumors in a progressive state that affect the retroperitoneum (contralateral ureter might be affected and can not serve as a control for the stented side)
  3. patients with Morbus Ormond (same reason as above)
  4. patients requiring ureteral stents bilaterally (same reason as above)
  5. long-term stented patients will be excluded as we are interested in evaluating the onset of changes in peristalsis rate which are expected to be most significant in an acute setting.
  6. patients with preexisting abnormalities/pathologies of the urinary tract e.g. reflux disease, megaureter or bladder dysfunctions as these will likely affect our results
  7. non English-speaking patients will be excluded as they will not be able to understand the letter of consents.

Exclusion criteria for control group:

  1. known preexisting pathology in the urinary tract (see above)
  2. volunteers who underwent previous surgical procedures on kidney, ureter or bladder within the past 5 years as this may change the starting position of our study
  3. patients currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin) because these medications are known to affect peristalsis
  4. patients currently taking calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil) because these medications are known to affect peristalsis
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • no Ureteral Stent - control group

    non-stented volunteers to receive ultrasound for peristalsis changes detection

  • Ureteral stent

    patients who receive stent, and to receive ultrasound for peristalsis changes detection in their stented and non-stented ureter

    Device: Ureteral Stent

Interventions

  • DeviceUreteral Stent

    patients who need to receive stent as per standard of care

05

What researchers measure

Primary outcomes

  1. Effect of stent on ureteral peristalsis in stented ureter

    before and after stent insertion (approximately 30 minutes)

    Time frame: before and after stent insertion (approximately 30 minutes)

Secondary outcomes

  1. Effect of stent on ureteral peristalsis in non-stented ureter

    Effect of stent on ureteral peristalsis in non-stented ureter pre and post stenting

    Time frame: 30 minutes (pre and post stenting)

06

Study locations

1 site
  • University of British Columbia/Vancouver General Hospital
    Vancouver, British Columbia V5Z 1M9, Canada
07

Registry details

Key details

Study ID
NCT01739738
Lead sponsor
University of British Columbia
Responsible party
Ben Chew, MD (Associate Professor, University of British Columbia) — Principal investigator
First posted
Dec 3, 2012
Start date
Dec 2012
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Mar 25, 2020

Study contacts

Ben Chew, MD
principal investigator · University of British Columbia

Oversight

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

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This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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