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A randomized clinical trial of urinary incontinence in older women: cost-effectiveness of protocolized assessment and evidence-based treatment

A randomized clinical trial of urinary incontinence in older women: cost-effectiveness of protocolized assessment and evidence-based treatment - Urinary incontinence in older women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31408
Enrollment
246
Registered
2008-11-26
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

involuntary loss of urine urinary incontinence

Interventions

The intervention will consist of a protocolized assessment of urinary incontinence and an evidence-based treatment, targeted to the patient. In the control group, women will receive standard care.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients are eligible for the study if they have symptoms of involuntary loss of urine, if they are able to fill in a questionnaire in Dutch, and if they have given informed consent

Exclusion criteria

Exclusion criteria: Patients will be excluded if they have urinary tract infections or overflow incontinence, are suffering from malignancies, are currently treated for urogynaecological conditions, have an indwelling catheter or are severely demented or in a poor physical condition (according to their GP). In cases of urinary tract infections subjects will be offered treatment and reconsidered at a later date if the incontinence persists.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the reduction in the severity of involuntary loss of urine after 12 months according to the Incontinence Severity Index (ISI). This index places women in one out of four categories of severity: slight, moderate, severe and very severe. We define success as improvement by at least one category on this index.

Secondary

MeasureTime frame
Secondary outcomes are the combination of severity and impact (ICIQ-score), the number of incontinent episodes (documented in the bladder diaries), the patient*s perception of improvement (GPI), the incontinence specific quality of life measured by the IIQ-7, the general health status (for which the EQ-5d and the MOS SF-20 are used) and the costs of the incontinence. Medical costs will be derived form the case record form (for general practice and hospital-related medical costs) and from patient questionnaires (use of absorbent pads).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)