Condition category
Urological and Genital Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes