The Impact of Ureteral Stents on Peristalsis

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).

Study Overview

• Status: Withdrawn
• Conditions: Tumor; Hydronephrosis; Kidney Stones
• Intervention / Treatment: Device: Ureteral Stent

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.

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of stent on ureteral peristalsis in stented ureter	before and after stent insertion (approximately 30 minutes)	before and after stent insertion (approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of stent on ureteral peristalsis in non-stented ureter	Effect of stent on ureteral peristalsis in non-stented ureter pre and post stenting	30 minutes (pre and post stenting)

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: peristalsis, kidney stones, hydronephrosis, ureteral stent
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Hydronephrosis
• Other Study ID Numbers: H12-03027