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
Protocol serial number	N0234175450
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	North Bristol NHS Trust (UK) NHS R&D Support Funding (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Added 28 July 2008: Compare health related QOL (using the USSQ) between the two groups at 2 weeks post insertion of stent
Key secondary outcome measure(s)	Added 28 July 2008: Difference in GP and hospital visits, UTI and antibiotic use between two groups with stent in situ
Completion date	01/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Lithotripsy Unit

Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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