motherfit

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23435

Enrollment

240

Registered

2016-07-18

Start date

2016-12-01

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

stress urinary incontinence, pelvic floor muscle training, peri-partum, pre-partum, post partum, grouptraining, randomized clinical trial, pregnancy

Interventions

INTERVENTION DURING PREGNANCY Study I: At 12 weeks gestation participants receive UI counselling by their midwife/obstetrician/gynaecologist or general practioner (GP). A short assessment of a correc

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • primi gravid woman • urinary incontinence (stress or mixed with predominant stress UI factor, according to Haylen (2010)(5) • motivated for participation in the motherfit program • written 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: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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 minimal 1 year hbac1 > 10 mmol/l) • 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 (< 6 months) • refusal to use a mApp or webApp

Design outcomes

Primary

Measure	Time frame
Study I and II primary: 18 months post partum - ICIQ-UI-SF	—

Secondary

Measure	Time frame
18 months post partum - Patient global impression of severity (PGI-S), - Incontinence Impact Questionnaire-7(IIQ-7); generic QoL (EQ-5D-5L) - Costs - Patient satisfaction	—

Contacts

Public ContactBary Berghmans

Pelvic care Center Maastricht Maastricht University Medical Center + P.O.Box 5800

bary.berghmans@mumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)