The measurement of urinary incontinence via survey questionnaires

ISRCTN	ISRCTN15411586
DOI	https://doi.org/10.1186/ISRCTN15411586
Protocol serial number	N/A
Sponsor	Bury Primary Care Trust (UK)
Funder	Funding provided by the public health department at Bury Primary Care Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Peter Elton
Scientific

Public Health Department
Bury Primary Care Trust
Bury
BL9 0EN
United Kingdom

Phone	+44 (0)161 762 3138
Email	peter.elton@burypct.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The trial aims to see if lead-in questions will affect the reported rate of urinary incontinence
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Information on the effect of leading questions on urinary incontinence.
Key secondary outcome measure(s)	The survey also contains questions relating to a range of health and lifestyle issues e.g smoking, alcohol use and diet.
Completion date	25/11/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1430
Key inclusion criteria	1. Patients registered with Bury General Practitioners. 2. People over the age of 18.
Key exclusion criteria	People under the age of 18.
Date of first enrolment	17/10/2005
Date of final enrolment	25/11/2005

Public Health Department

Bury
BL9 0EN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan