The Impact of Ureteral Stents on Peristalsis

• Sponsor: University of British Columbia (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01739738
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones; Tumor; Hydronephrosis	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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Ureteral Stents on Peristalsis
• Study Start Date: Dec 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Effect of stent on ureteral peristalsis in non-stented ureter [30 minutes (pre and post stenting)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of British Columbia/Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Ben Chew, MD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ben Chew, MD, Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01739738
• Other Study ID Numbers: H12-03027
• First Posted: Dec 3, 2012
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Ben Chew, MD, Associate Professor, University of British Columbia: peristalsis, kidney stones, hydronephrosis, ureteral stent
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Hydronephrosis

Study Results

No Results Posted as of Mar 25, 2020