involuntary loss of urine urinary incontinence
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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