Transperineal Ultrasound as a Biofeedback Tool for Pelvic Floor Muscle Therapy in Postpartum Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorSingapore General Hospital

About this trial

Regular and effective pelvic floor muscle exercises after vaginal birth are crucial in reducing the risk of pelvic floor disorders in women. Pelvic floor muscle exercises are generally encouraged by healthcare providers to their patients after birth. However, it is often difficult to confirm whether a patient is performing pelvic floor muscle contractions correctly. A supervised pelvic floor physiotherapy session allows a professional to assess the pelvic floor and give their verbal feedback to patients. However even in this setting, patient's are reliant on the physiotherapist and have no way to assess their own performance. The 'biofeedback approach' allows for the clinician and patient to visually assess and modify their performance and can potentially allow for more effective therapy and better engagement. Transperineal ultrasonography is a widely available, safe and non-invasive biofeedback tool that can used at the bedside in order to assess pelvic floor muscle contractions. Our aim is to assess if using transperineal ultrasound can enhance the ability of postpartum patients to perform effective pelvic floor muscle therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female participants

Aged 21 - 45 years old.

Within 4 months of a singleton, vaginal delivery

Disqualifiers

Currently pregnant

Over 4 months since vaginal birth.

Previous caesarean delivery.

Previous pelvic floor surgery (eg. pelvic floor repair, continence surgery, cervicetomy,cosmetic pelvic floor procedures)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Visual biofeedback using transperineal ultrasound

    Diagnostic test

    Transperineal ultrasound with visual biofeedback

  • Transperineal ultrasound without visual biofeedback

    Diagnostic test

    Transperineal ultrasound without visual biofeedback

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Control ArmActive comparator 1 intervention
Group B: Study ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Does visual feedback with transperineal ultrasound improve the effectiveness of pelvic floor muscle therapy in postpartum patients?

Is the change in antero-posterior pelvic hiatal diameter between rest and pelvic floor contraction better in the study arm compared to the control arm?

Time frame
Baseline

Secondary outcomes

1

Are postpartum patients who have trained with visual biofeedback more likely to continue to perform pelvic floor muscle therapy than those who do not train with visual biofeedback?

What is the reported change in frequency of pelvic floor contractions in the study group compared to the control group at the 3 month follow up?

Time frame
Baseline and 3 months later
2

Do postpartum patients who train with visual biofeedback continue to perform effective pelvic floor muscle contractions 3 months after pelvic floor muscle training

In the study group, is change in anteroposterior diameter maintained at the 3-month follow up?

Time frame
Baseline and at 3 months
3

Does pelvic floor contraction strength improve after 3 months of pelvic floor muscle therapy with visual biofeedback compared to those who did not receive visual biofeedback

Does the change in antero-posterior pelvic hiatal diameter continue to be effective in the study group compared to the control group at the 3-month follow up?

Time frame
Baseline and 3 months

Other outcomes

Sponsors and contacts

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