Health TrialsbyHealthPanel

Pelvic Floor Muscle Training During Pregnancy

ConditionsUrinary IncontinenceAnal IncontinencePelvic Organ ProlapseSexual DysfunctionPelvic Floor Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Southern Denmark

About this trial

The project seeks to investigate effectiveness of PFMT during pregnancy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

up to 12+6 weeks of gestation to receive invitation and up to 16+0 weeks of gestation to be enrolled

Para 0 (no previous birth or pregnancy > 16 weeks of gestation)

Understands, writes, and reads fluently in Danish or English

Has a smart phone or computer/tablet to reach the training program

Disqualifiers

Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety)

Active substance abuse

Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support)

Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers)

Trial design

Design model

Parallel

Treatments tested in this trial

  • PFMT

    Behavioral

    A structured home-based pelvic floor muscle training programme consisting of progressive pelvic floor muscle exercises, training reminders as well as supportive information with educational materials and habit-building strategies. Participants are advised to perform pelvic floor muscle training three to five times per week during pregnancy and continue after birth.

  • Standard care

    Behavioral

    Routine antenatal care provided according to local clinical practice. This may include general information about pelvic floor muscle training but does not include access to the study programme, study application, structured training support, or study-specific reminders.

Treatment groups

804 Participants
are divided into 2 treatment groups
Group A: Pelvic Floor Muscle Training (PFMT)Experimental treatment 1 intervention
Group B: Standard carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The presence of urinary incontinence (UI) at 3 months postpartum

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score \> 0.

Time frame
At 3 months follow-up after giving birth

Secondary outcomes

1

The presence of urinary incontinence at inclusion

ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome)

Time frame
At baseline: inclusion
2

Urinary incontinence severity at inclusion

ICIQ-UI SF score between 0-21. Outcome is continuous

Time frame
At baseline: inclusion
3

The presence of urinary incontinence at the 2nd trimester of pregnancy

ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome)

Time frame
At follow-up gestational age 26 weeks and 0 days
4

Urinary incontinence severity at the 2nd trimester of pregnancy

ICIQ-UI SF score between 0-21. Outome is continuous

Time frame
At follow-up gestational age 26 weeks and 0 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Kolding Sygehus

Collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

Collaborator

Odense University Hospital

Collaborator

Hospital Sønderjylland

Collaborator

Source ClinicalTrials.gov
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