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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47306

Enrollment

150

Registered

2018-08-08

Start date

2018-03-20

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

pre-partum incontinence urine loss during physical effort

Interventions

-INTERVENTION DURING PREGNANCY At 12 weeks gestation participants receive UI counselling by their midwife/obstetrician/gynaecologist. A short assessment of a correct contraction of PFMs by observatio

group training

pelvic floor muscle training

pre-partum

stress urinary incontinence

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * adult gravid woman * 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 during pregnancy * high-risk pregnancy giving, resulting in a contra-indication for performing intensive PFM exercises (f.i. placenta praevia, vaginal blood loss, partus prematurus imminens) * 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

Measure	Time frame
-OUTCOME PARAMETERS/TIME (endpoints) Primary: 18 months post partum - ICIQ-UI-SF at baseline, at 34 weeks gestation and post partum at 6 weeks, 6, and 18 months.	—

Secondary

Measure	Time 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 baseline, at 34 weeks gestation and post partum at 6 weeks, 6, and 18 months. - Patient satisfaction at 34 weeks	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)