Condition category
Urological and Genital Diseases
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
16/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unimaas.nl/default.asp?taal=en

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes