The Impact of Ureteral Stents on Peristalsis

NCT ID: NCT01739738

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

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).

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.

Conditions

Kidney Stones; Tumor; Hydronephrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ureteral stent

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

Ureteral Stent

Intervention Type: DEVICE

patients who need to receive stent as per standard of care

no Ureteral Stent - control group

non-stented volunteers to receive ultrasound for peristalsis changes detection

No interventions assigned to this group

Interventions

Ureteral Stent

patients who need to receive stent as per standard of care

Intervention Type: DEVICE

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.

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ben Chew, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Chew, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia/Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-03027

Identifier Type: -

Identifier Source: org_study_id