Effects of introducing a specialised nurse in the care of community-dwelling women suffering from urinary incontinence

ISRCTN	ISRCTN15553880
DOI	https://doi.org/10.1186/ISRCTN15553880
Secondary identifying numbers	N/A

Submission date: 16/01/2007
Registration date: 16/01/2007
Last edited: 06/01/2021

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

Ms M Du Moulin
Scientific

University of Maastricht (UM)
Faculty of Health Sciences
Department of Nursing Studies
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 388 1829
Email	m.dumoulin@zw.unimaas.nl

Study information

Study design	Randomised controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Effects of introducing a specialised nurse in the care of community-dwelling women suffering from urinary incontinence
Study objectives	It is hypothesised that care given by a continence nurse will lead to a reduction in episodes of urinary incontinence and an improvement in quality of life.
Ethics approval(s)	Approval received from the Ethics Committee of the Atrium Medical Centre on the 28/11/2002, ref: 02-P-46
Health condition(s) or problem(s) studied	Urinary incontinence
Intervention	Intervention: The intervention involved a registered nurse specialised in the care of incontinent patients. Over a period of one year, this nurse advised and guided patients suffering from stress, urge or mixed incontinence. Based on her knowledge and experience, the nurse assessed the patients, using history-taking and post-void residual urine measurement. The nurse advised the patient about the best treatment, guided by a protocol written by a multidisciplinary team. This protocol presented a management plan including evidence-based interventions for the treatment of stress, urge and mixed incontinence. Also the nurse provided lifestyle and behavioural interventions tailored to the individual patient as well as information about pads. All patients returned after three, six, and 12 months for follow-up and review of bladder diaries and questionnaires. After each visit, the nurse reported her findings to the patient's GP, who remained responsible for the care of the patient. Control: Usual care comprised care delivered by the GP and access to health care workers in the field of continence care (e.g., physiotherapist, urologist). In most cases a physiotherapist gives pelvic floor muscle exercises. Depending on the GP women are asked to return after three or six months for follow up.
Intervention type	Other
Primary outcome measure	Number of incontinent episodes: measured by a three-day bladder diary recording the frequency and volume of the incontinent episodes as well as the number of pads used throughout the day and night.
Secondary outcome measures	1. Quality of life: measured with the Incontinence Impact Questionnaire (30 items covering five domains: mobility, emotional functioning, physical activity, social functioning and embarrassment) 2. Amount of bother caused by incontinence is measured by the Urogenital Distress Inventory (19 items covering five domains: discomfort/pain, urinary incontinence, overactive bladder, genital prolapse, obstructive micturition) 3. EuroQol (EQ-5D): a generic questionnaire to measure quality of life (the EQ-5D defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) 4. Patient satisfaction with care: measured on a ten-point scale ranging from 'very poor' (1) to 'excellent' (10)
Overall study start date	01/05/2003
Completion date	01/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	228
Total final enrolment	38
Key inclusion criteria	1. Women aged 18 years or older 2. Consulting their General Practitioner (GP) with symptoms of stress, urge or mixed incontinence
Key exclusion criteria	1. Women suffering from gynecological diseases (e.g., malignancy), dysuria, cystocele, fistula, neurological diseases (e.g., Cerebral Vascular Accident [CVA], Multiple Sclerosis [MS], Parkinson's Disease), urinary tract infection 2. Not being able to fill in the questionnaires or to follow treatment 3. Women who had given birth within three months preceding recruitment
Date of first enrolment	01/05/2003
Date of final enrolment	01/03/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

University of Maastricht (UM)

Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (UM) (The Netherlands)
Hospital/treatment centre

Faculty of Health Sciences
Department of Nursing Studies
PO Box 616
Maastricht
6200 MD
Netherlands

Website	http://www.unimaas.nl/default.asp?taal=en
"ROR"	https://ror.org/02jz4aj89

Funders

Funder type

Other

Central Sickfund (CZ) health care insurance (The Netherlands)

No information available

University Maastricht (UM) (The Netherlands)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2007	06/01/2021	Yes	No

Editorial Notes

06/01/2021: Publication reference and total final enrolment added.