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Multicentered randomized controlled trial to test the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.

Multicentered randomized controlled trial to test the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. - Urodynamics prior to stress urinary incontinence surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30485
Enrollment
290
Registered
2007-09-28
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Urinary incontinence. Unintentional urinary loss.

Interventions

Intervention: stress urinary incontinence therapy based on history, clinical examination, pad test and 48h voiding diary versus therapy based on the same parameters AND urodynamic findings

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All women, not previously operated for stress incontinence, seeking help for urinary stress incontinence where conservative therapy in particular physiotherapy has failed and are opting and candidates for surgical therapy can participate in the study. Incontinence must have been demonstrated on physical examination and/or micturition diary. Patients can be included by gynaecologists or urologists who are cooperating in the study.

Exclusion criteria

Exclusion criteria: Women with a history of urge incontinence. Women with previous urinary incontinence surgery. Women incapable to read and speak Dutch. Women not giving informed consent.

Design outcomes

Primary

MeasureTime frame
Primary outcome: Non inferiority of the improvement of the UDI one year after treatment in the non urodynamics group.

Secondary

MeasureTime frame
Secondary outcomes: Cure of incontinence as measured with pad test and voiding diary. Complications of surgery for stress incontinence in particular re-operation and overactive bladder symptoms of quality of life as measured by validated questionnaires.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)