The Impact of Ureteral Stents on Peristalsis

NCT01739738 | Withdrawn

• 1 other identifier: H12-03027
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Kidney Stones; Tumor; Hydronephrosis

Keywords

peristalsis, kidney stones, hydronephrosis, ureteral stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of stent on ureteral peristalsis in non-stented ureter

  30 minutes (pre and post stenting)

Study Arms (2)

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

Ureteral Stent DEVICE

patients who need to receive stent as per standard of care

Ureteral stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• stone disease
• localized tumor disease
• hydronephrosis of unknown ethiology
• patients who receive a prophylactic stent before a planned operation.

You may not qualify if:

• Patients being septic and in a life-threatening condition before or after stent-insertion
• 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)
• patients with Morbus Ormond (same reason as above)
• patients requiring ureteral stents bilaterally (same reason as above)
• 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.
• patients with preexisting abnormalities/pathologies of the urinary tract e.g. reflux disease, megaureter or bladder dysfunctions as these will likely affect our results
• non English-speaking patients will be excluded as they will not be able to understand the letter of consents.
• known preexisting pathology in the urinary tract (see above)
• 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
• patients currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin) because these medications are known to affect peristalsis
• patients currently taking calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil) because these medications are known to affect peristalsis

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia/Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Kidney Calculi; Neoplasms; Hydronephrosis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Chew, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)