Condition category
Urological and Genital Diseases
Date applied
10/10/2005
Date assigned
13/10/2005
Last edited
19/10/2009
Prospective/Retrospective
Prospectively 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 Peter Elton

ORCID ID

Contact details

Public Health Department
Bury Primary Care Trust
Bury
BL9 0EN
United Kingdom
+44 (0)161 762 3138
peter.elton@burypct.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The trial aims to see if lead-in questions will affect the reported rate of urinary incontinence

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Condition

Urinary incontinence

Intervention

The control group will be asked:
Do you ever leak any water (urine) when you don't mean to? Yes/No

The intervention group will be asked some related questions preceding the urinary incontinence question i.e.
1. Do you have to pass water (urine) at least once during the night? Yes/No
2. Do you have to pass water at least five times per day? Yes/No
3. Do you need to pass water when you hear running water? Yes/No
4. Do you sometimes have the sensation of not emptying your bladder after you have finished passing water? Yes/No
5. Do you get a sudden strong urge to pass water? Yes/No
6. Do you have difficulty in controlling your water? Yes/No
7. Do you ever leak any water when you don't mean to? Yes/No

Differences in the response rate between the two groups will be analysed for statistical significance.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Information on the effect of leading questions on urinary incontinence.

Secondary outcome measures

The survey also contains questions relating to a range of health and lifestyle issues e.g smoking, alcohol use and diet.

Overall trial start date

17/10/2005

Overall trial end date

25/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients registered with Bury General Practitioners.
2. People over the age of 18.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1430

Participant exclusion criteria

People under the age of 18.

Recruitment start date

17/10/2005

Recruitment end date

25/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Public Health Department
Bury
BL9 0EN
United Kingdom

Sponsor information

Organisation

Bury Primary Care Trust (UK)

Sponsor details

21 Silver Street
Bury
BL9 0EN
United Kingdom
+44 (0)161 762 3136
paul.campbell@burypct.nhs.uk

Sponsor type

Government

Website

http://www.burypct.nhs.uk

Funders

Funder type

Government

Funder name

Funding provided by the public health department at Bury Primary Care Trust (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

No publication intended as of 19/10/2009

Publication citations

Additional files

Editorial Notes