A randomised controlled trial comparing physiotherapy to electromagnetic stimulation for urinary incontinence

A randomised controlled trial comparing physiotherapy to electromagnetic stimulation for urinary incontinence - The PIE study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38783

Enrollment

240

Registered

2014-01-14

Start date

2018-08-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

urinary loss

Interventions

Physiotherapy / bladdertraining versus electromagnetic stimulation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: urinary incontience

Exclusion criteria

Exclusion criteria: Metal or electronic inplants Pregnancy Cardiac arrhythmia Neurological disease History of anti-incontinece surgery Pelvic malignancy History of pelvic radiotherapy Physiotherapy for incontinence in the last 6 months

Design outcomes

Primary

Measure	Time frame
Primary objective: Subjective improvement of urinary incontinence (PGI-I)	—

Secondary

Measure	Time frame
Secondary objectives: Objective (using stress test, padtest, bladder diaries, Sandvik score) and subjective cure of incontinence (questionnaires) Complicaties en de novo urogenital symptoms Effect on defaecation (questionnaires) Effect on dyspareunia (questionnaires) Discomfort of treatment (VAS Scores) Cost/ effectiveness analysis	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)