A prospective randomised controlled trial comparing two ureteric stents (CE marked) using a validated quality of life (HRQoL) questionnaire

ISRCTN ISRCTN85311380
DOI https://doi.org/10.1186/ISRCTN85311380
Secondary identifying numbers N0234175450
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
28/07/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr K Davenport
Scientific

Lithotripsy Unit
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Phone +44
Email drkimdav@aol.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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(s)Added 28 July 2008:
Granted by North Bristol NHS Trust Research Ethics Committee.
Health condition(s) or problem(s) studiedUrological and Genital Diseases:
InterventionInformed 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 typeOther
Primary outcome measureAdded 28 July 2008:
Compare health related QOL (using the USSQ) between the two groups at 2 weeks post insertion of stent
Secondary outcome measuresAdded 28 July 2008:
Difference in GP and hospital visits, UTI and antibiotic use between two groups with stent in situ
Overall study start date01/01/2002
Completion date01/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants100
Key inclusion criteriaAdded 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.
Key exclusion criteriaAdded 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
Date of first enrolment01/01/2002
Date of final enrolment01/02/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Lithotripsy Unit
Bristol
BS10 5NB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Bristol NHS Trust (UK) NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results 01/03/2008 No No