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Long term effects of multidisciplinary assessment and post partum Pelvic Floor Muscle Group Treatment in women with stress urinary incontinence after vaginal delivery compared to care-as-usual: a randomized controlled trial

Long term effects of multidisciplinary assessment and post partum Pelvic Floor Muscle Group Treatment in women with stress urinary incontinence after vaginal delivery compared to care-as-usual: a randomized controlled trial - motherfit post partum

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47366
Enrollment
90
Registered
2016-12-22
Start date
2017-11-13
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

post partum incontinence urine loss during physical effort

Interventions

Intervention after vaginal delivery At week 6-8 post-partum routine control all women with UI besides those women who (still) participate in study I of motherfit are counselled by their midwife/obs

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * adult woman after vaginal delivery * urinary incontinence (stress or mixed with predominant stress UI factor) * motivated for participation in the motherfit program * signed informed consent * competent to speak and understand Dutch language and to read and fill in forms independent * mApps on tablet (Apple or Android) or webApp available

Exclusion criteria

Exclusion criteria: - UI prior to pregnancy, still existing after vaginal delivery * suffering from significant exercise limitations or co-morbidities (physical or psychological) that would restrain a woman from participation in motherfit (group) training * history of chronic neurological disorders or diseases related to UI (f.i_ multiple sclerosis, cerebro-vascular accident, diabetes mellitus) * urinary tract infection (urine-sediment, urine culture) * history of anti-incontinence or urogynecological surgery * women who are expected to be lost to follow-up (e.g. because of a planned change of residency) * recent pelvic physiotherapy (

Design outcomes

Primary

MeasureTime frame
primary: 18 months post partum - ICIQ-UI-SF at 6 weeks (baseline), 4 months (end training), 9, and 18 months.

Secondary

MeasureTime frame
Secondary: 18 months post partum - Patient global impression of severity (PGI-S), - Incontinence Impact Questionnaire-7(IIQ-7): generic QoL (EQ-5D-5L) - Costs, costs questionnaire at 6 weeks post partum (baseline), 4 months (end training), 9, and 18 months. - Patient satisfaction at 4 months

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)