Kidney StonesNCT01739738
The Impact of Ureteral Stents on Peristalsis
An observational study of Kidney Stones and Tumor, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones, Tumor, Hydronephrosis
- What is being tested?
- Ureteral Stent
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- stone disease
- localized tumor disease
- hydronephrosis of unknown ethiology
- patients who receive a prophylactic stent before a planned operation.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia/Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
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).
Read the 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
- Being tested
- Ureteral Stent
- Keywords
- peristalsis, kidney stones, hydronephrosis, ureteral stent
- Medical subject headings
- Kidney Calculi, Neoplasms, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral StentDevice
patients who need to receive stent as per standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of stent on ureteral peristalsis in stented ureter
before and after stent insertion (approximately 30 minutes)
Measured: before and after stent insertion (approximately 30 minutes)
Secondary outcomes (1)
Effect of stent on ureteral peristalsis in non-stented ureter
Effect of stent on ureteral peristalsis in non-stented ureter pre and post stenting
Measured: 30 minutes (pre and post stenting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Study did not start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben Chew, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739738
- Sponsor's protocol ID
- H12-03027
- Status last verified
- Mar 2020
- First submitted
- 29 Nov 2012
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ureteral Stents on Peristalsis
- ClinicalTrials.gov ID
- NCT01739738
- Acronym / sponsor ID
- H12-03027
- Conditions
- Kidney Stones, Tumor, Hydronephrosis
- Keywords
- peristalsis, kidney stones, hydronephrosis, ureteral stent
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no Ureteral Stent - control group | – | –non-stented volunteers to receive ultrasound for peristalsis changes detection |
| Ureteral stent | – | Device: Ureteral Stentpatients who receive stent, and to receive ultrasound for peristalsis changes detection in their stented and non-stented ureter |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- stone disease
- localized tumor disease
- hydronephrosis of unknown ethiology
- patients who receive a prophylactic stent before a planned operation.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteral Stentpatients who need to receive stent as per standard of care | Device | Ureteral stent |
Primary outcome
Effect of stent on ureteral peristalsis in stented ureter
Time frame: before and after stent insertion (approximately 30 minutes)
before and after stent insertion (approximately 30 minutes)
1 secondary outcome
Effect of stent on ureteral peristalsis in non-stented ureter
Time frame: 30 minutes (pre and post stenting)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chew, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones and Tumor, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of stent on ureteral peristalsis in stented ureter (time frame: before and after stent insertion (approximately 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.