Contact information
Type
Scientific
Primary contact
Dr K Davenport
ORCID ID
Contact details
Lithotripsy Unit
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44
drkimdav@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234175450
Study information
Scientific title
Acronym
Study hypothesis
To study and compare the effect of 2 different indwelling ureteric stents on patients symptoms and quality of life. Ureteric stents need to be stuff enough for east of insertion and soft enough for increased comfort whilst in situ. Previous studies have shown that ureteric stents cause side effects in the majority of patients. We aim to assess the difference between side effects with the present stent compared to a newer developed stent. The main objective is to see whether either stent is superior with regard to the frequency and severity of side effects.
Ethics approval
Added 28 July 2008:
Granted by North Bristol NHS Trust Research Ethics Committee.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and Genital Diseases:
Intervention
Informed written consent will be obtained from 100 prospective patients. Pre stent symptom questionnaire will be completed pre-procedure. Each patient will be randomised to receive either the Bard Inlay stent of the Microvasice Polaris stent. The type of stent used will be blinded from the patient and the researcher recording information. Once the stent has been indwelling for one week, the stent in situ questionnaire will be completed. Following removal of the stent the post stent questionnaire will be completed. On completion of the questionnaires, comparative scores from the 2 groups will undergo statistical analysis.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Added 28 July 2008:
Compare health related QOL (using the USSQ) between the two groups at 2 weeks post insertion of stent
Secondary outcome measures
Added 28 July 2008:
Difference in GP and hospital visits, UTI and antibiotic use between two groups with stent in situ
Overall trial start date
01/01/2002
Overall trial end date
01/02/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Added 28 July 2008:
Patients (aged 16 yrs or over) requiring the placement of a ureteric stent for stone disease, including obstructing ureteric stones, large stones prior to lithotripsy or post ureteroscopy plus or minus stone fragmentation.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Added 28 July 2008:
Those with pelvi-ureteric junction obstruction, upper tract malignancy, indwelling stent, concurrent urinary tract infection, pregnancy, bilateral instrumentation or aged less than 16 yrs of age
Recruitment start date
01/01/2002
Recruitment end date
01/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lithotripsy Unit
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Bristol NHS Trust (UK) NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results presented at British Association of Urological Surgeons 2008 Annual Scientific Meeting, 23-27 June 2008, Manchester, UK in un-moderated poster presentation section ((http://www3.interscience.wiley.com/journal/120088988/issue):
Prospective randomised trial comparing the Bard Inlay ureteric stent with the Boston Scientific Polaris stent using the validated ureteric stent symptom questionnaire. K Davenport, V Kumar, J Collins, R Melotti, FX Keeley, AG Timoney. BJU Int 2008; 101 (5): 52