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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26828
Enrollment
246
Registered
2008-01-15
Start date
2008-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Urinary incontinence (NLD: incontinentie voor urine).

Interventions

All included women will be interviewed about their clinical history and asked to complete a three-day bladder diary and to fill in self-report questionnaires. The additional assesments for the interv

Sponsors

University Medical Center Groningen (UMCG)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The source population consists of women aged 55 or older who are registered in the practices of 26 general practitiones in the northern part of The Netherlands. Patients are eligible for the study if the 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: Patient 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.

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).

Secondary

MeasureTime frame
Secondary outcomes are the combination of severity and impact, the number of incontinent episodes, the patient’s perception of improvement, the incontinence specific quality of life, the general health status and the costs of the incontinence.

Contacts

Public ContactE. Visser

UMCG, huisartsgeneeskunde, sector F Postbus 196

els.visser@med.umcg.nl050-3632989

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)