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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR829
• Date of registration: 07/12/2006
• Primary sponsor: University Maastricht (UM), Faculty of Health Sciences, Department of Nursing Studies
• Public title: Effects of introducing a specialized nurse in the care of community-dwelling women suffering from urinary incontinence.
• Scientific title: Effects of introducing a specialized nurse in the care of community-dwelling women suffering from urinary incontinence. - N/A
• Date of first enrolment: 1/5/2003
• Target sample size: 228
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=829
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: M. Moulin, Du

• Name: M. Moulin, Du

Key inclusion & exclusion criteria

Inclusion criteria: Women aged 18 years or older, consulting their GP with symptoms of stress, urge or mixed incontinence.
Exclusion criteria: Excluded are women suffering from gynecological diseases (e.g., malignancy), dysuria, cystocele, fistula, neurological diseases (e.g., CVA, MS, Parkinson), urinary tract infection, not being able to fill in the questionnaires or to follow treatment. Also women who had given birth within 3 months preceding recruitment were excluded.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Urinary incontinence

Intervention(s)

The intervention involved a registered nurse specialized 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 postvoid 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 3,6, 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
pelvic floor muscle exercises are given by a physiotherapist). Depending on the GP
women are asked to return after 3 or 6 months for follow up.

Primary Outcome(s)

Number of incontinent episodes: measured by a 3-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(s)

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 5 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 10-point scale ranging from 'very poor' (1) to 'excellent' (10).

Secondary ID(s)

ISRCTN15553880

N/A

Source(s) of Monetary Support

University Maastricht (UM), Central Sickfund (CZ) health care insurance