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The Impact of Ureteral Stents on Peristalsis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01739738
First received: November 29, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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).


Condition Intervention
Kidney Stones,
Tumor,
Hydronephrosis
Device: Ureteral Stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Ureteral Stents on Peristalsis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Effect of stent on ureteral peristalsis in stented ureter [ Time Frame: before and after stent insertion (approximately 30 minutes) ] [ Designated as safety issue: No ]
    before and after stent insertion (approximately 30 minutes)


Secondary Outcome Measures:
  • Effect of stent on ureteral peristalsis in non-stented ureter [ Time Frame: 30 minutes (pre and post stenting) ] [ Designated as safety issue: No ]
    Effect of stent on ureteral peristalsis in non-stented ureter pre and post stenting


Estimated Enrollment: 55
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
patients who need to receive stent as per standard of care

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739738

Contacts
Contact: Olga Arsovska 6048754111 ext 62421 olga.arsovska@ubc.ca

Locations
Canada, British Columbia
University of British Columbia/Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Olga Arsovska    6048754111 ext 62421    olga.arsovska@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Ben Chew, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01739738     History of Changes
Other Study ID Numbers: H12-03027
Study First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
peristalsis, kidney stones, hydronephrosis, ureteral stent

Additional relevant MeSH terms:
Hydronephrosis
Kidney Calculi
Nephrolithiasis
Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014