ong 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

Phase 3

Recruiting

Conditions: pre-partum incontinence
urine loss during physical effort
10010273

Registration Number: NL-OMON47306

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

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

* 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 (< 6 months)
* refusal to use a mApp or webApp

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-OUTCOME PARAMETERS/TIME (endpoints)<br /><br>Primary: 18 months post partum<br /><br>- ICIQ-UI-SF<br /><br>at baseline, at 34 weeks gestation and post partum at 6 weeks, 6, and 18<br /><br>months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: 18 months post partum<br /><br>- Patient global impression of severity (PGI-S),<br /><br>- Incontinence Impact Questionnaire-7(IIQ-7); generic QoL (EQ-5D-5L)<br /><br>- Costs, costs questionnaire<br /><br>at baseline, at 34 weeks gestation and post partum at 6 weeks, 6, and 18 months.<br /><br><br /><br>- Patient satisfaction<br /><br>at 34 weeks </p><br>