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van CCT (UK)

van CCT (UK)

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

- candidate number2356
- NTR NumberNTR829
- Date ISRCTN created16-jan-2007
- date ISRCTN requested29-dec-2006
- Date Registered NTR7-dec-2006
- Secondary IDsN/A 
- Public TitleEffects of introducing a specialized nurse in the care of community-dwelling women suffering from urinary incontinence.
- Scientific TitleEffects of introducing a specialized nurse in the care of community-dwelling women suffering from urinary incontinence.
- hypothesisIt is hypothesized that care given by a continence nurse will lead to a reduction in episodes of urinary incontinence and an improvement in quality of life.
- Healt Condition(s) or Problem(s) studiedUrinary incontinence
- Inclusion criteriaWomen aged 18 years or older, consulting their GP with symptoms of stress, urge or mixed incontinence.
- Exclusion criteriaExcluded 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2003
- planned closingdate1-mrt-2005
- Target number of participants228
- InterventionsThe 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.

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 outcomeNumber 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 outcome1. 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).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Maastricht (UM), Faculty of Health Sciences, Department of Nursing Studies
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM), Central Sickfund (CZ) health care insurance
- Publications1. J Wound Ostomy Continence Nurs. 2007 Nov-Dec;34(6):631-40.

2. 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.
- Brief summaryResearch shows that urinary incontinence often remains inadequately treated. Clinicians fail to diagnose the underlying cause or to recommend treatment. In the literature, there are indications that the continence nurses' diagnoses and the treatment advices are beneficial in terms of clinical outcomes. However, the precise short and long term effects are unclear. This study investigates the short and long term effects of the introduction of a continence nurse in the care of community-dwelling women suffering from urinary incontinence. In a cluster randomized study 101 GPs were randomly assigned to the intervention (50 GPs) and control group (51 GPs). Patients visiting their GP in the intervention group received care by the continence nurse. Patients visiting their GP in the control group received usual care. At baseline, after 3, 6 and 12 months data on frequency and volume of incontinence, quality of life, and patient satisfaction were collected.
- Main changes (audit trail)
- RECORD7-dec-2006 - 2-jul-2008

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