Quality of LifeNCT00919386
Ureteral Stent Size Measurement Study
An observational study of Quality of Life, run by CAMC Health System at 1 site in United States.
Trial summary
To examine a patient's quality of life using three methods for measuring stent size: (a) direct measurement, (b) patient height, and (c) a standardized formula. The intent of the study is to show if there is a difference in a patient's quality of life, postoperative symptoms, pain medication and anticholinergic use by… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community patients who present to Charleston area Medical Center (CAMC) or the private urology clinics of Drs. Davalos,Martinez,Tierney with the requirement of ureteral stent would be screened for possible enrillment in the study.
Who may be able to join
- All patients presenting to Charleston Area Medical Center between the ages of 18 and 90 years old who will undergo cytoscopy or ureteroscopy with ureteral stent placement will be eligible for the study.
Who cannot join
- Patients excluded from this study will be those who are less than 18 years of age, pregnant women, and patients who are septic on presentation, as well as patients who have had lower extremity amputations or are wheelchair bound.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urology center of charleston
Charleston, West Virginia, 25301
About this study
Official title: Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?
To examine a patient's quality of life using three methods for measuring stent size: (a) direct measurement, (b) patient height, and (c) a standardized formula. The intent of the study is to show if there is a difference in a patient's quality of life, postoperative symptoms, pain medication and anticholinergic use by using one of these specific methods for stent size determination. No method is interventional in this study.
Read the detailed description
Ureteral stent placement is common in Urologic practice and many studies have been done looking at factors to improve stent related symptoms, but few have used a validated questionnaire to assess these symptoms affect on quality of life.We plan to prospectively randomize patients to three separate techniques such as (a) direct measurement,(b) patient height, and (c) a standardized formula for the determination of stent size. Using a validated questionnaire, the Ureteral Stent Symptoms Questionnaire (USSQ), we will assess whether there is a difference in outcome measures such as patient quality of life, need for pain medications and anticholinergics, and in postoperative symptoms based on one of these techniques. The USSQ was developed by Joshi et al to assess the impact of health-related quality of life issues related to ureteral stents. Data from USSQ questionnaire will be collected 7-10 days post-operatively as well as 4 weeks post-op and then this will be aggregated for our outcome measures to determine which method of stent size give better outcomes.
- Conditions
- Quality of Life
- Keywords
- Ureteric Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 Direct ureteric measurement | This is determined by using a 5 French Pollack Open-Ended Flexi-Tip Ureteral catheter (Cook, Spencer, Indiana) to cannulate the ureteral orifice. A retrograde pyelogram will be done at the conclusion of the procedure and the Pollack will be advanced to the pyeloureteral junction (PUJ) under fluoroscopy. At this point the length of the distance between the PUJ and vesicoureteral junction (VUJ) will be recorded and stent length determined based on this measurement. | |
| 2 Based on patient height | We will use the height measurement criteria used by Lee et al in their study. Patients less than 5'2" will receive a 22 cm stent, 5'3"-5'7" will get a 24 cm stent, 5'8"-5'10" will get a 26 cm stent, 5'11" to 6'1" will get a 28 cm stent, and all patients greater than 6'2" will receive a 30 cm stent. | |
| 3 Based on a predetermined formula | We will use the formula described by Wieder. Stent length in cm= patients height in inches - 42. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference in patient quality of life (QOL), post-op symptoms, and pain medication and anticholinergic use in patients who receive ureteral stents where size is determined by direct measurement, patient height,a standardized formula.
Measured: within 4 weeks post-porcedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Deem, DO, CAMC Health System
- Investigators
- Samuel Deem, M.D., Principal investigator, CAMC Medical Staff - with admitting privileges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919386
- Sponsor's protocol ID
- 09-03-2137
- Status last verified
- Jul 2015
- First submitted
- 15 May 2009
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?
- ClinicalTrials.gov ID
- NCT00919386
- Acronym / sponsor ID
- 09-03-2137
- Conditions
- Quality of Life
- Keywords
- Ureteric Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Jun 2009 (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.
To examine a patient's quality of life using three methods for measuring stent size: (a) direct measurement, (b) patient height, and (c) a standardized formula. The intent of the study is to show if there is a difference in a patient's quality of life, postoperative symptoms, pain medication and anticholinergic use by using one of these specific methods for stent size determination. No method is interventional in this study.
Detailed description
Ureteral stent placement is common in Urologic practice and many studies have been done looking at factors to improve stent related symptoms, but few have used a validated questionnaire to assess these symptoms affect on quality of life.We plan to prospectively randomize patients to three separate techniques such as (a) direct measurement,(b) patient height, and (c) a standardized formula for the determination of stent size. Using a validated questionnaire, the Ureteral Stent Symptoms Questionnaire (USSQ), we will assess whether there is a difference in outcome measures such as patient quality of life, need for pain medications and anticholinergics, and in postoperative symptoms based on one of these techniques. The USSQ was developed by Joshi et al to assess the impact of health-related quality of life issues related to ureteral stents. Data from USSQ questionnaire will be collected 7-10 days post-operatively as well as 4 weeks post-op and then this will be aggregated for our outcome measures to determine which method of stent size give better outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Direct ureteric measurement | – | –This is determined by using a 5 French Pollack Open-Ended Flexi-Tip Ureteral catheter (Cook, Spencer, Indiana) to cannulate the ureteral orifice. A retrograde pyelogram will be done at the conclusion of the procedure and the Pollack will be advanced to the pyeloureteral junction (PUJ) under fluoroscopy. At this point the length of the distance between the PUJ and vesicoureteral junction (VUJ) will be recorded and stent length determined based on this measurement. |
| 2 Based on patient height | – | –We will use the height measurement criteria used by Lee et al in their study. Patients less than 5'2" will receive a 22 cm stent, 5'3"-5'7" will get a 24 cm stent, 5'8"-5'10" will get a 26 cm stent, 5'11" to 6'1" will get a 28 cm stent, and all patients greater than 6'2" will receive a 30 cm stent. |
| 3 Based on a predetermined formula | – | –We will use the formula described by Wieder. Stent length in cm= patients height in inches - 42. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community patients who present to Charleston area Medical Center (CAMC) or the private urology clinics of Drs. Davalos,Martinez,Tierney with the requirement of ureteral stent would be screened for possible enrillment in the study.
Key inclusion criteria (1 listed)
- All patients presenting to Charleston Area Medical Center between the ages of 18 and 90 years old who will undergo cytoscopy or ureteroscopy with ureteral stent placement will be eligible for the study.
Key exclusion criteria (1 listed)
- Patients excluded from this study will be those who are less than 18 years of age, pregnant women, and patients who are septic on presentation, as well as patients who have had lower extremity amputations or are wheelchair bound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the difference in patient quality of life (QOL), post-op symptoms, and pain medication and anticholinergic use in patients who receive ureteral stents where size is determined by direct measurement, patient height,a standardized formula.
Time frame: within 4 weeks post-porcedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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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.
Samuel Deem, M.D. principal investigator
CAMC Medical Staff - with admitting privileges
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 Quality of Life, run by CAMC Health System at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2015. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the difference in patient quality of life (QOL), post-op symptoms, and pain medication and anticholinergic use in patients who receive ureteral stents where size is determined by direct measurement, patient height,a standardized formula. (time frame: within 4 weeks post-porcedure). 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 31 Jul 2015.