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
Scientific
Lithotripsy Unit
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Phone | +44 |
---|---|
drkimdav@aol.com |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | 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(s) | Added 28 July 2008: Granted by North Bristol NHS Trust Research Ethics Committee. |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/01/2002 |
Completion date | 01/02/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Not Specified |
Target number of participants | 100 |
Key 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. |
Key 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 |
Date of first enrolment | 01/01/2002 |
Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lithotripsy Unit
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |