Contact information
Type
Scientific
Primary contact
Ms M Du Moulin
ORCID ID
Contact details
University of Maastricht (UM)
Faculty of Health Sciences
Department of Nursing Studies
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 1829
m.dumoulin@zw.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Approval received from the Ethics Committee of the Atrium Medical Centre on the 28th November 2002 (ref: 02-P-46).
Study design
Randomised, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/05/2003
Overall trial end date
01/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 18 years or older
2. Consulting their General Practitioner (GP) with symptoms of stress, urge or mixed incontinence
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
228
Participant 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
Recruitment start date
01/05/2003
Recruitment end date
01/03/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University of Maastricht (UM)
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
University Maastricht (UM) (The Netherlands)
Sponsor details
Faculty of Health Sciences
Department of Nursing Studies
P.O. Box 616
Maastricht
6200 MD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Central Sickfund (CZ) health care insurance (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Maastricht (UM) (The Netherlands)
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
Basic results (scientific)
Publication list
Du Moulin M., Hamers J. Paulus A., Berendsen C., Halfens R. (2005). The role of the nurse in community continence care: a systematic review. International Journal of Nursing Studies 42 (4), 479-492.