A randomised controlled trial of educational group sessions and conventional individual management in the physiotherapeutic treatment of female urinary incontinence (FUI)

ISRCTN	ISRCTN23418270
DOI	https://doi.org/10.1186/ISRCTN23418270
Secondary identifying numbers	593

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Sara Demain
Scientific

Physiotherapy Department
Victoria Hospital
Friary Road
Lichfield
WS13 6QN
United Kingdom

Phone	+44 (0)1543 414 555 ext 2154
Email	abc@email.com

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	A randomised controlled trial of educational group sessions and conventional individual management in the physiotherapeutic treatment of female urinary incontinence (FUI)
Study objectives	To test the hypothesis that the new treatment approach of an educational group has a significantly greater effect on: 1. Physical symptoms 2. Life quality in women with FUI than the individual home help method
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and genital diseases: Incontinence
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	Pad test, pelvic floor muscle power, Incontinence report questionnaire, Symptom severity Index and Visual Analogue Scale.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/1996
Completion date	01/03/1998

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Female
Target number of participants	Not provided at time of registration
Total final enrolment	44
Key inclusion criteria	All female patients aged 18-75 years with a clinical diagnosis of stress and/or urge incontinence will be considered for inclusion.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1996
Date of final enrolment	01/03/1998

Physiotherapy Department

Lichfield
WS13 6QN
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive West Midlands (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2001	09/08/2021	Yes	No

09/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.